Pregabalin
Generic name: pregabalin · Brand names: Lyrica, Lyrica CR (extended-release tablets): NOT covered on this record
Quick facts
Drug class
Value
anticonvulsant (per MedlinePlus). The generic label text read does not state a pharmacologic class.
Source
https://medlineplus.gov/druginfo/meds/a605045.html ("Pregabalin is in a class of medications called anticonvulsants.")
Rx or otc
Value
Rx
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display (package label text: "Rx only")
Controlled schedule
Value
Schedule V (CV)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display (section 9.1: "Pregabalin is a Schedule V controlled substance."; Highlights: "PREGABALIN capsules, for oral use CV")
Forms and strengths
- Capsules (section 3): 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
Forms source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display section 3; https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:LYRICA&limit=1; https://medlineplus.gov/druginfo/meds/a605045.html
Generic available
Value
yes
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display (this label is a generic: Aurobindo Pharma Limited, ANDA205321 per earlier DailyMed marketing-information read)
Common use one line
Anticonvulsant used for nerve pain from diabetes, shingles and spinal cord injury, for fibromyalgia, and as add-on treatment for partial-onset seizures (label section 1).
What it is used for
Pregabalin capsules are indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 1 month of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
1
Source text (exact source wording)
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
How it works
Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. The label says the mechanism has not been fully elucidated.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
12.1 (first paragraph)
Source text (exact source wording)
Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals.
Dosage: adults
Capsules are given orally with or without food. For diabetic nerve pain, begin at 150 mg/day (50 mg three times a day) and increase to 300 mg/day within 1 week; doses above 300 mg/day are not recommended. For postherpetic neuralgia, begin at 150 mg/day and increase to 300 mg/day within 1 week, with up to 600 mg/day only for patients with ongoing pain who tolerate 300 mg daily. For partial-onset seizures in adults, 150 mg/day initial and 600 mg/day maximum in 2 or 3 divided doses. For fibromyalgia, 300 to 450 mg/day, beginning at 75 mg two times a day. For spinal cord injury, 150 to 600 mg/day, beginning at 75 mg two times a day. When stopping, taper gradually over a minimum of 1 week.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
2.1-2.6
Source text (exact source wording)
2.1 Important Administration Instructions
Pregabalin capsules are given orally with or without food.
When discontinuing pregabalin capsules, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.4)].
Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7)].
2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults
The maximum recommended dose of pregabalin capsules is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Although pregabalin capsules were also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1)].
2.3 Postherpetic Neuralgia in Adults
The recommended dose of pregabalin capsules is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150 mg to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin capsules, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)].
2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older
Adults (17 years and older): Recommended Initial Dosage 150 mg/day; Recommended Maximum Dosage 600 mg/day; 2 or 3 divided doses
Pediatric patients weighing 30 kg or more: 2.5 mg/kg/day; 10 mg/kg/day (not to exceed 600 mg/day); 2 or 3 divided doses
Pediatric patients weighing less than 30 kg: 3.5 mg/kg/day; 14 mg/kg/day; 1 month to less than 4 years of age: 3 divided doses; 4 years of age and older: 2 or 3 divided doses
Both the efficacy and adverse event profiles of pregabalin capsules have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of pregabalin capsules have not been formally studied.
The efficacy of adjunctive pregabalin capsules in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin capsules with gabapentin cannot be offered.
2.5 Management of Fibromyalgia in Adults
The recommended dose of pregabalin capsules for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although pregabalin capsules were also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1)].
2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults
The recommended dose range of pregabalin capsules for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate pregabalin capsules may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)].
Pregabalin capsules are given orally with or without food.
When discontinuing pregabalin capsules, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.4)].
Because pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7)].
2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults
The maximum recommended dose of pregabalin capsules is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Although pregabalin capsules were also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1)].
2.3 Postherpetic Neuralgia in Adults
The recommended dose of pregabalin capsules is 75 mg to 150 mg two times a day, or 50 mg to 100 mg three times a day (150 mg to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate pregabalin capsules, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)].
2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older
Adults (17 years and older): Recommended Initial Dosage 150 mg/day; Recommended Maximum Dosage 600 mg/day; 2 or 3 divided doses
Pediatric patients weighing 30 kg or more: 2.5 mg/kg/day; 10 mg/kg/day (not to exceed 600 mg/day); 2 or 3 divided doses
Pediatric patients weighing less than 30 kg: 3.5 mg/kg/day; 14 mg/kg/day; 1 month to less than 4 years of age: 3 divided doses; 4 years of age and older: 2 or 3 divided doses
Both the efficacy and adverse event profiles of pregabalin capsules have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of pregabalin capsules have not been formally studied.
The efficacy of adjunctive pregabalin capsules in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin capsules with gabapentin cannot be offered.
2.5 Management of Fibromyalgia in Adults
The recommended dose of pregabalin capsules for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although pregabalin capsules were also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1)].
2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults
The recommended dose range of pregabalin capsules for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate pregabalin capsules may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)].
Dosage: children
Only partial-onset seizure use is established in children. Patients 1 month and older: pediatric patients weighing 30 kg or more start at 2.5 mg/kg/day (maximum 10 mg/kg/day, not to exceed 600 mg/day) in 2 or 3 divided doses; those under 30 kg start at 3.5 mg/kg/day (maximum 14 mg/kg/day). For the other indications, safety and effectiveness in pediatric patients have not been established.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
2.4 (incl. Table 1); 8.4
Source text (exact source wording)
2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older
Adults (17 years and older): Recommended Initial Dosage 150 mg/day; Recommended Maximum Dosage 600 mg/day; 2 or 3 divided doses
Pediatric patients weighing 30 kg or more: 2.5 mg/kg/day; 10 mg/kg/day (not to exceed 600 mg/day); 2 or 3 divided doses
Pediatric patients weighing less than 30 kg: 3.5 mg/kg/day; 14 mg/kg/day; 1 month to less than 4 years of age: 3 divided doses; 4 years of age and older: 2 or 3 divided doses
Both the efficacy and adverse event profiles of pregabalin capsules have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of pregabalin capsules have not been formally studied.
The efficacy of adjunctive pregabalin capsules in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin capsules with gabapentin cannot be offered.
8.4 Pediatric Use
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury
Safety and effectiveness in pediatric patients have not been established.
Fibromyalgia
Safety and effectiveness in pediatric patients have not been established.
Adjunctive Therapy for Partial-Onset Seizures
Safety and effectiveness in pediatric patients below the age of 1 month have not been established.
4 to Less Than 17 Years of Age with Partial-Onset Seizures
The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled study (n=295) [see Clinical Studies (14.3)].
1 Month to Less than 4 Years of Age with Partial-Onset Seizures
The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 1 month to less than 4 years of age have been established in a 14-day double-blind, placebo-controlled study (N=175) [see Clinical Studies (14.3)].
The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.
Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older
Adults (17 years and older): Recommended Initial Dosage 150 mg/day; Recommended Maximum Dosage 600 mg/day; 2 or 3 divided doses
Pediatric patients weighing 30 kg or more: 2.5 mg/kg/day; 10 mg/kg/day (not to exceed 600 mg/day); 2 or 3 divided doses
Pediatric patients weighing less than 30 kg: 3.5 mg/kg/day; 14 mg/kg/day; 1 month to less than 4 years of age: 3 divided doses; 4 years of age and older: 2 or 3 divided doses
Both the efficacy and adverse event profiles of pregabalin capsules have been shown to be dose-related.
The effect of dose escalation rate on the tolerability of pregabalin capsules have not been formally studied.
The efficacy of adjunctive pregabalin capsules in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of pregabalin capsules with gabapentin cannot be offered.
8.4 Pediatric Use
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury
Safety and effectiveness in pediatric patients have not been established.
Fibromyalgia
Safety and effectiveness in pediatric patients have not been established.
Adjunctive Therapy for Partial-Onset Seizures
Safety and effectiveness in pediatric patients below the age of 1 month have not been established.
4 to Less Than 17 Years of Age with Partial-Onset Seizures
The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled study (n=295) [see Clinical Studies (14.3)].
1 Month to Less than 4 Years of Age with Partial-Onset Seizures
The safety and effectiveness of pregabalin as adjunctive treatment for partial-onset seizures in pediatric patients 1 month to less than 4 years of age have been established in a 14-day double-blind, placebo-controlled study (N=175) [see Clinical Studies (14.3)].
Dosage adjustments
Drug interaction caps
No fixed dose cap for interactions was found. The label says to monitor and consider a low starting dose when pregabalin is co-prescribed with an opioid or other CNS depressant, or in patients with underlying respiratory impairment.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
5.5
Kidney
Dose is adjusted by creatinine clearance (Table 2). For example, at CLcr 30 to 60 mL/min the total daily doses are 75, 150, 225 or 300 mg/day, and below 15 mL/min they are 25, 25 to 50, 50 to 75 or 75 mg/day once daily. After each 4-hour hemodialysis a supplemental dose is given. Use in children with kidney impairment has not been studied.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
2.7; 8.6
Source text (exact source wording)
2.7 Dosing for Adult Patients with Renal Impairment
In view of dose-dependent adverse reactions and since pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of pregabalin capsules in pediatric patients with compromised renal function has not been studied.
Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2.
For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).
Table 2. Pregabalin Dosage Adjustment Based on Renal Function (total daily dose in mg/day; the label lists four columns, one per usual daily dose)
Greater than or equal to 60 mL/min: 150, 300, 450, 600; BID or TID
30 to 60 mL/min: 75, 150, 225, 300; BID or TID
15 to 30 mL/min: 25 to 50, 75, 100 to 150, 150; QD or BID
Less than 15 mL/min: 25, 25 to 50, 50 to 75, 75; QD
Supplementary dosage following hemodialysis (mg): Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg. Patients on the 25 mg to 50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg. Patients on the 50 mg to 75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg. Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg.
In view of dose-dependent adverse reactions and since pregabalin is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of pregabalin capsules in pediatric patients with compromised renal function has not been studied.
Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2.
For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).
Table 2. Pregabalin Dosage Adjustment Based on Renal Function (total daily dose in mg/day; the label lists four columns, one per usual daily dose)
Greater than or equal to 60 mL/min: 150, 300, 450, 600; BID or TID
30 to 60 mL/min: 75, 150, 225, 300; BID or TID
15 to 30 mL/min: 25 to 50, 75, 100 to 150, 150; QD or BID
Less than 15 mL/min: 25, 25 to 50, 50 to 75, 75; QD
Supplementary dosage following hemodialysis (mg): Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg. Patients on the 25 mg to 50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg. Patients on the 50 mg to 75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg. Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg.
Liver
No liver impairment dosing information was found in the sections read.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Elderly
Pregabalin is substantially excreted by the kidney, so elderly patients with kidney impairment need dose adjustment.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
8.5 (last paragraph)
Source text (exact source wording)
8.5 Geriatric Use
Pregabalin is known to be substantially excreted by the kidney, and the risk of toxic reactions to pregabalin may be greater in patients with impaired renal function. Because pregabalin is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment [see Dosage and Administration (2.7)].
Pregabalin is known to be substantially excreted by the kidney, and the risk of toxic reactions to pregabalin may be greater in patients with impaired renal function. Because pregabalin is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment [see Dosage and Administration (2.7)].
Missed dose
Label
If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next one at the regular time. Do not take two doses at the same time.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
17
Source text (exact source wording)
Section 17 (patient counseling) - Missed Dose
Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time.
Counsel patients if they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take two doses at the same time.
Medlineplus
MedlinePlus gives similar advice for capsules and oral solution: take it when you remember, skip it if it is almost time for the next dose, and do not double up.
Source
MedlinePlus Pregabalin (https://medlineplus.gov/druginfo/meds/a605045.html), Last Revised - 05/15/2020
Section
MedlinePlus
Source text (exact source wording)
If you are taking the capsules or the oral solution and forget to take a dose and remember a few hours later, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
There is no specific antidote. Care is supportive, with attention to the airway, and about 50% of pregabalin is cleared in 4 hours of hemodialysis. Deaths have been reported in overdose, alone or with other CNS depressants. Call poison control at 1-800-222-1222; call 911 if the person has collapsed, had a seizure, has trouble breathing or cannot be awakened.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display); MedlinePlus Pregabalin (https://medlineplus.gov/druginfo/meds/a605045.html), Last Revised - 05/15/2020
Section
10; MedlinePlus
Source text (exact source wording)
10 OVERDOSAGE
Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
In the postmarketing experience, the most commonly reported adverse events observed with pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state, agitation, and restlessness. Seizures and heart block have also been reported. Deaths have been reported in the setting of lone pregabalin overdose and in combination with other CNS depressants.
Treatment or Management of Overdose
There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Pregabalin can be removed by hemodialysis. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans
In the postmarketing experience, the most commonly reported adverse events observed with pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state, agitation, and restlessness. Seizures and heart block have also been reported. Deaths have been reported in the setting of lone pregabalin overdose and in combination with other CNS depressants.
Treatment or Management of Overdose
There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Pregabalin can be removed by hemodialysis. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Storage
Store at 20° to 25°C (68° to 77°F) in the original package, and keep out of the reach of children. This is the Aurobindo capsule label; other labelers can differ.
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Section
16; Medication Guide
Source text (exact source wording)
16 HOW SUPPLIED/STORAGE AND HANDLING
Storage and Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Medication Guide: Store pregabalin capsules at room temperature, 20° to 25°C (68° to 77°F) in its original package.
Safely throw away any pregabalin capsules that are out of date or no longer needed.
Keep pregabalin capsules and all medicines out of the reach of children.
Storage and Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Medication Guide: Store pregabalin capsules at room temperature, 20° to 25°C (68° to 77°F) in its original package.
Safely throw away any pregabalin capsules that are out of date or no longer needed.
Keep pregabalin capsules and all medicines out of the reach of children.
Boxed warning
NONE (confirmed: the full printer-friendly label text, 156,071 characters, has no BOXED WARNING heading and no 'WARNING:' box)Contraindications
Do not take pregabalin if you are known to be allergic to it or any of its components. Angioedema and hypersensitivity reactions have occurred.
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Section
4
Source text (exact source wording)
Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2)].
Warnings and precautions
Angioedema with swelling of the face, mouth and neck has been reported, including life-threatening cases with breathing problems. Stop pregabalin immediately. Use caution with a previous episode of angioedema or with drugs such as ACE inhibitors.
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5.1 Angioedema
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Source text (exact source wording)
5.1 Angioedema
There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with these symptoms.
Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.
There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with these symptoms.
Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.
Hypersensitivity reactions (skin redness, blisters, hives, rash, trouble breathing, wheezing) have been reported shortly after starting. Stop pregabalin immediately.
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5.2 Hypersensitivity
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Source text (exact source wording)
5.2 Hypersensitivity
There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue pregabalin immediately in patients with these symptoms.
There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue pregabalin immediately in patients with these symptoms.
Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior for any indication. In pooled trials the rate was 0.43% on drug versus 0.24% on placebo, about one extra case per 530 patients treated. Monitor for new or worsening depression or mood changes.
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5.3 Suicidal Behavior and Ideation
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5.3 Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in pregabalin capsules, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.4)]. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in pregabalin capsules, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.4)]. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
Stopping suddenly can cause insomnia, nausea, headache, anxiety, sweating and diarrhea and may increase seizures. Taper gradually over a minimum of 1 week.
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5.4 Abrupt or Rapid Discontinuation
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Source text (exact source wording)
5.4 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation
As with all antiepileptic drugs (AEDs), withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders.
Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea [see Adverse Reactions (6.2), Drug Abuse and Dependence (9.3)]. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.3)].
If pregabalin is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly.
As with all antiepileptic drugs (AEDs), withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders.
Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea [see Adverse Reactions (6.2), Drug Abuse and Dependence (9.3)]. Suicidal behavior and ideation have also been reported in patients after discontinuation of pregabalin [see Warnings and Precautions (5.3)].
If pregabalin is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly.
Serious, life-threatening or fatal breathing depression has been linked to pregabalin when taken with CNS depressants such as opioids or with underlying respiratory impairment. Monitor and consider a low starting dose.
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5.5 Respiratory Depression
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Source text (exact source wording)
5.5 Respiratory Depression
There is evidence from case reports, human studies, and animal studies associating pregabalin with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including pregabalin).
There is more limited evidence from case reports, animal studies, and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.
There is evidence from case reports, human studies, and animal studies associating pregabalin with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including pregabalin).
There is more limited evidence from case reports, animal studies, and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.
Pregabalin may cause dizziness and sleepiness that can impair driving or operating machinery. In adult trials dizziness occurred in 30% versus 8% on placebo and somnolence in 23% versus 8%.
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5.6 Dizziness and Somnolence
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5.6 Dizziness and Somnolence
Pregabalin may cause dizziness and somnolence. Inform patients that pregabalin-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery [see Patient Counseling Information (17)].
In the pregabalin controlled trials in adult patients, dizziness was experienced by 30% of pregabalin-treated patients compared to 8% of placebo-treated patients; somnolence was experienced by 23% of pregabalin-treated patients compared to 8% of placebo-treated patients. Dizziness and somnolence generally began shortly after the initiation of pregabalin therapy and occurred more frequently at higher doses. Dizziness and somnolence were the adverse reactions most frequently leading to withdrawal (4% each) from controlled studies.
Pregabalin may cause dizziness and somnolence. Inform patients that pregabalin-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery [see Patient Counseling Information (17)].
In the pregabalin controlled trials in adult patients, dizziness was experienced by 30% of pregabalin-treated patients compared to 8% of placebo-treated patients; somnolence was experienced by 23% of pregabalin-treated patients compared to 8% of placebo-treated patients. Dizziness and somnolence generally began shortly after the initiation of pregabalin therapy and occurred more frequently at higher doses. Dizziness and somnolence were the adverse reactions most frequently leading to withdrawal (4% each) from controlled studies.
Peripheral edema occurred in 6% versus 2% on placebo. Higher rates of weight gain and edema occur with a thiazolidinedione diabetes medicine. Use caution in NYHA Class III or IV heart failure.
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5.7 Peripheral Edema
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5.7 Peripheral Edema
Pregabalin treatment may cause peripheral edema. In controlled clinical trials in adult patients, the incidence of peripheral edema was 6% in the pregabalin group compared with 2% in the placebo group. In controlled clinical trials, 0.5% of pregabalin patients and 0.2% placebo patients withdrew due to peripheral edema.
Higher frequencies of weight gain and peripheral edema were observed in patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone.
As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, exercise caution when co-administering pregabalin and these agents.
Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, exercise caution when using pregabalin in these patients.
Pregabalin treatment may cause peripheral edema. In controlled clinical trials in adult patients, the incidence of peripheral edema was 6% in the pregabalin group compared with 2% in the placebo group. In controlled clinical trials, 0.5% of pregabalin patients and 0.2% placebo patients withdrew due to peripheral edema.
Higher frequencies of weight gain and peripheral edema were observed in patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone.
As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, exercise caution when co-administering pregabalin and these agents.
Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, exercise caution when using pregabalin in these patients.
A gain of 7% or more over baseline weight was seen in 9% of pregabalin patients and 2% of placebo patients.
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5.8 Weight Gain
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5.8 Weight Gain
Pregabalin treatment may cause weight gain. In pregabalin controlled clinical trials in adult patients of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 9% of pregabalin-treated patients and 2% of placebo-treated patients. Few patients treated with pregabalin (0.3%) withdrew from controlled trials due to weight gain.
Pregabalin treatment may cause weight gain. In pregabalin controlled clinical trials in adult patients of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 9% of pregabalin-treated patients and 2% of placebo-treated patients. Few patients treated with pregabalin (0.3%) withdrew from controlled trials due to weight gain.
A high incidence of hemangiosarcoma was seen in two mouse strains; the clinical significance is unknown.
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5.9 Tumorigenic Potential
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5.9 Tumorigenic Potential
In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, an unexpectedly high incidence of hemangiosarcoma was identified in two different strains of mice [see Nonclinical Toxicology (13.1)]. The clinical significance of this finding is unknown.
In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, an unexpectedly high incidence of hemangiosarcoma was identified in two different strains of mice [see Nonclinical Toxicology (13.1)]. The clinical significance of this finding is unknown.
Blurred vision was reported by 7% of pregabalin patients versus 2% on placebo. Tell your doctor about vision changes.
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5.10 Ophthalmological Effects
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5.10 Ophthalmological Effects
In controlled studies in adult patients, a higher proportion of patients treated with pregabalin reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision-related events (primarily blurred vision).
Although the clinical significance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur. If visual disturbance persists, consider further assessment. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions [see Patient Counseling Information (17)].
In controlled studies in adult patients, a higher proportion of patients treated with pregabalin reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision-related events (primarily blurred vision).
Although the clinical significance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur. If visual disturbance persists, consider further assessment. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions [see Patient Counseling Information (17)].
Creatine kinase at least three times the upper limit of normal was seen in 1.5% of pregabalin patients and 0.7% of placebo patients. Report unexplained muscle pain, tenderness or weakness.
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5.11 Creatine Kinase Elevations
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5.11 Creatine Kinase Elevations
Pregabalin treatment was associated with creatine kinase elevations. In all controlled trials in adult patients across multiple patient populations, 1.5% of patients on pregabalin and 0.7% of placebo patients had a value of creatine kinase at least three times the upper limit of normal. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue treatment with pregabalin if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Pregabalin treatment was associated with creatine kinase elevations. In all controlled trials in adult patients across multiple patient populations, 1.5% of patients on pregabalin and 0.7% of placebo patients had a value of creatine kinase at least three times the upper limit of normal. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue treatment with pregabalin if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
A potentially clinically significant platelet decrease occurred in 3% of pregabalin patients and 2% of placebo patients; bleeding reactions were not increased.
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5.12 Decreased Platelet Count
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5.12 Decreased Platelet Count
Pregabalin treatment was associated with a decrease in platelet count. In the overall database of controlled trials in adult patients, 2% of placebo patients and 3% of pregabalin patients experienced a potentially clinically significant decrease in platelets, defined as 20% below baseline value and less than 150 × 103/µL. In randomized controlled trials, pregabalin was not associated with an increase in bleeding-related adverse reactions.
Pregabalin treatment was associated with a decrease in platelet count. In the overall database of controlled trials in adult patients, 2% of placebo patients and 3% of pregabalin patients experienced a potentially clinically significant decrease in platelets, defined as 20% below baseline value and less than 150 × 103/µL. In randomized controlled trials, pregabalin was not associated with an increase in bleeding-related adverse reactions.
The mean PR interval increase was 3 to 6 msec at doses of 300 mg/day or more.
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5.13 PR Interval Prolongation
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5.13 PR Interval Prolongation
Pregabalin treatment was associated with PR interval prolongation. In analyses of clinical trial ECG data in adult patients, the mean PR interval increase was 3 to 6 msec at pregabalin doses greater than or equal to 300 mg/day.
Pregabalin treatment was associated with PR interval prolongation. In analyses of clinical trial ECG data in adult patients, the mean PR interval increase was 3 to 6 msec at pregabalin doses greater than or equal to 300 mg/day.
Pregnancy and breastfeeding
Observational studies suggest a possible small increase in overall major birth defects with no consistent pattern, and data were insufficient to identify other risks. Small amounts of pregabalin have been detected in breast milk, and because of a potential risk of tumorigenicity the label says breastfeeding is not recommended.
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Section
8.1, 8.2 (Risk Summary paragraphs)
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8.1 Pregnancy
Risk Summary
Observational studies on the use of pregabalin during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data). Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin.
Postmarketing data suggest that extended gabapentinoid use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone (see Clinical Considerations). There are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to pregabalin alone late in pregnancy may cause withdrawal signs and symptoms.
8.2 Lactation
Risk Summary
Small amounts of pregabalin have been detected in the milk of lactating women.
Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant [see Nonclinical Toxicology (13.1)]. Available clinical study data in patients greater than 12 years of age do not provide a clear conclusion about the potential risk of tumorigenicity with pregabalin [see Warnings and Precautions (5.9)]. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Risk Summary
Observational studies on the use of pregabalin during pregnancy suggest a possible small increase in the rate of overall major birth defects, but there was no consistent or specific pattern of major birth defects identified (see Data). Available postmarketing data on miscarriage and other maternal, fetal, and long term developmental adverse effects were insufficient to identify risk associated with pregabalin.
Postmarketing data suggest that extended gabapentinoid use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone (see Clinical Considerations). There are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to pregabalin alone late in pregnancy may cause withdrawal signs and symptoms.
8.2 Lactation
Risk Summary
Small amounts of pregabalin have been detected in the milk of lactating women.
Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant [see Nonclinical Toxicology (13.1)]. Available clinical study data in patients greater than 12 years of age do not provide a clear conclusion about the potential risk of tumorigenicity with pregabalin [see Warnings and Precautions (5.9)]. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Side effects
Common
The label's most common reactions in adults (5% or more and twice placebo) are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (difficulty with concentration/attention). In children with partial-onset seizures they are increased weight and increased appetite. For example, dizziness was 21% overall versus 5% on placebo in diabetic nerve pain and 26% versus 9% in postherpetic neuralgia.
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Section
Highlights; 6.1 (Tables 4-10, selected rows)
Threshold
greater than or equal to 5% and twice placebo
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Highlights: Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). (6.1)
Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. (6.1)
6.1: Most Common Adverse Reactions in All Controlled Clinical Studies in Adults: In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).
Selected rows from the label's adverse reaction tables (values as printed, %; columns in the order printed in the label).
Table 4 (DPN; 75 mg/day, 150 mg/day, 300 mg/day, 600 mg/day, All PGB, Placebo): Dizziness 8, 9, 23, 29, 21, 5; Somnolence 4, 6, 13, 16, 12, 3; Peripheral edema 4, 6, 9, 12, 9, 2; Dry mouth 3, 2, 5, 7, 5, 1; Weight gain 0, 4, 4, 6, 4, 0; Blurry vision 3, 1, 3, 6, 4, 2; Thinking abnormal 1, 0, 1, 3, 2, 0.
Table 5 (PHN; 75 mg/d, 150 mg/d, 300 mg/d, 600 mg/d, All PGB, Placebo): Dizziness 11, 18, 31, 37, 26, 9; Somnolence 8, 12, 18, 25, 16, 5; Peripheral edema 0, 8, 16, 16, 12, 4; Dry mouth 7, 7, 6, 15, 8, 3; Weight gain 1, 2, 5, 7, 4, 0; Blurry vision 1, 5, 5, 9, 5, 3; Thinking abnormal 0, 2, 1, 6, 2, 2.
Table 6 (adult partial-onset seizures; 150 mg/d, 300 mg/d, 600 mg/d, All PGB, Placebo): Dizziness 18, 31, 38, 32, 11; Somnolence 11, 18, 28, 22, 11; Ataxia 6, 10, 20, 15, 4; Weight Gain 5, 7, 16, 12, 1; Blurred Vision 5, 8, 12, 10, 4; Diplopia 5, 7, 12, 9, 4.
Table 7 (patients 4 to less than 17 years, partial-onset seizures; 2.5 mg/kg/day, 10 mg/kg/day, All PGB, Placebo): Somnolence 17, 26, 21, 14; Weight increased 4, 13, 8, 4; Increased appetite 7, 10, 8, 4.
Table 9 (fibromyalgia; All PGB, Placebo): Dizziness 38, 9; Somnolence 20, 4; Weight increased 11, 2; Vision blurred 8, 1; Dry mouth 8, 2; Edema peripheral 6, 2.
Table 10 (spinal cord injury; PGB, Placebo): Somnolence 35.7, 11.5; Dizziness 20.9, 6.9; Dry mouth 11.0, 2.9; Fatigue 11.0, 4.0; Edema peripheral 10.4, 5.2.
Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. (6.1)
6.1: Most Common Adverse Reactions in All Controlled Clinical Studies in Adults: In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).
Selected rows from the label's adverse reaction tables (values as printed, %; columns in the order printed in the label).
Table 4 (DPN; 75 mg/day, 150 mg/day, 300 mg/day, 600 mg/day, All PGB, Placebo): Dizziness 8, 9, 23, 29, 21, 5; Somnolence 4, 6, 13, 16, 12, 3; Peripheral edema 4, 6, 9, 12, 9, 2; Dry mouth 3, 2, 5, 7, 5, 1; Weight gain 0, 4, 4, 6, 4, 0; Blurry vision 3, 1, 3, 6, 4, 2; Thinking abnormal 1, 0, 1, 3, 2, 0.
Table 5 (PHN; 75 mg/d, 150 mg/d, 300 mg/d, 600 mg/d, All PGB, Placebo): Dizziness 11, 18, 31, 37, 26, 9; Somnolence 8, 12, 18, 25, 16, 5; Peripheral edema 0, 8, 16, 16, 12, 4; Dry mouth 7, 7, 6, 15, 8, 3; Weight gain 1, 2, 5, 7, 4, 0; Blurry vision 1, 5, 5, 9, 5, 3; Thinking abnormal 0, 2, 1, 6, 2, 2.
Table 6 (adult partial-onset seizures; 150 mg/d, 300 mg/d, 600 mg/d, All PGB, Placebo): Dizziness 18, 31, 38, 32, 11; Somnolence 11, 18, 28, 22, 11; Ataxia 6, 10, 20, 15, 4; Weight Gain 5, 7, 16, 12, 1; Blurred Vision 5, 8, 12, 10, 4; Diplopia 5, 7, 12, 9, 4.
Table 7 (patients 4 to less than 17 years, partial-onset seizures; 2.5 mg/kg/day, 10 mg/kg/day, All PGB, Placebo): Somnolence 17, 26, 21, 14; Weight increased 4, 13, 8, 4; Increased appetite 7, 10, 8, 4.
Table 9 (fibromyalgia; All PGB, Placebo): Dizziness 38, 9; Somnolence 20, 4; Weight increased 11, 2; Vision blurred 8, 1; Dry mouth 8, 2; Edema peripheral 6, 2.
Table 10 (spinal cord injury; PGB, Placebo): Somnolence 35.7, 11.5; Dizziness 20.9, 6.9; Dry mouth 11.0, 2.9; Fatigue 11.0, 4.0; Edema peripheral 10.4, 5.2.
Less common
Less common events listed by the label include abdominal pain, allergic reaction, fever, anxiety, nystagmus, tinnitus, diplopia, impotence and urinary incontinence (frequent: at least 1/100 patients). Postmarketing reports include headache, nausea, diarrhea, gynecomastia, breast enlargement and bullous pemphigoid.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
6.1 (Other Adverse Reactions); 6.2
Source text (exact source wording)
Other Adverse Reactions Observed During the Clinical Studies of Pregabalin: Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients.
Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever. Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching. Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus. Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence.
Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever. Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching. Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus. Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence.
Serious
Label
Serious items include angioedema, allergic reactions, suicidal thoughts, breathing depression with opioids or other CNS depressants, and withdrawal symptoms such as seizures after stopping.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
5; 6.2
Source text (exact source wording)
Serious reactions are described in 5.1 to 5.13 above (angioedema, hypersensitivity, suicidal behavior and ideation, withdrawal effects, respiratory depression, dizziness and somnolence, peripheral edema, weight gain, tumorigenic potential, ophthalmological effects, creatine kinase elevations, decreased platelet count, PR interval prolongation).
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of pregabalin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders – Headache
Gastrointestinal Disorders – Nausea, Diarrhea
Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement
Skin and subcutaneous tissue disorders – Bullous pemphigoid
There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking pregabalin with opioids or other CNS depressants, or in the setting of underlying respiratory impairment.
In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
There are postmarketing reports of withdrawal symptoms after discontinuation of pregabalin. Reported adverse reactions include, but are not limited to, seizures, depression, suicidal ideation and behavior, agitation, confusion, disorientation, psychotic symptoms, anxiety, insomnia, nausea, pain, sweating, tremor, headache, dizziness, malaise, and diarrhea.
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of pregabalin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders – Headache
Gastrointestinal Disorders – Nausea, Diarrhea
Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement
Skin and subcutaneous tissue disorders – Bullous pemphigoid
There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking pregabalin with opioids or other CNS depressants, or in the setting of underlying respiratory impairment.
In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
There are postmarketing reports of withdrawal symptoms after discontinuation of pregabalin. Reported adverse reactions include, but are not limited to, seizures, depression, suicidal ideation and behavior, agitation, confusion, disorientation, psychotic symptoms, anxiety, insomnia, nausea, pain, sweating, tremor, headache, dizziness, malaise, and diarrhea.
Medlineplus
MedlinePlus says to call your doctor right away for vision changes, hives, rash, swelling of the face or limbs, shortness of breath, wheezing, muscle pain with fever, chest pain, or difficulty breathing with confusion or extreme sleepiness.
Source
MedlinePlus Pregabalin (https://medlineplus.gov/druginfo/meds/a605045.html), Last Revised - 05/15/2020
Section
MedlinePlus
Source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
blurred vision, double vision, or other changes in eyesight
hives
rash
itching
blisters
swelling of the eyes, face, throat, mouth, lips, gums, tongue, head or neck
swelling of the arms, hands, feet, ankles, or lower legs
shortness of breath
wheezing
muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever
chest pain
difficulty breathing; bluish-tinged skin, lips, or fingernails; confusion; or extreme sleepiness
blurred vision, double vision, or other changes in eyesight
hives
rash
itching
blisters
swelling of the eyes, face, throat, mouth, lips, gums, tongue, head or neck
swelling of the arms, hands, feet, ankles, or lower legs
shortness of breath
wheezing
muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever
chest pain
difficulty breathing; bluish-tinged skin, lips, or fingernails; confusion; or extreme sleepiness
Led to discontinuation
In controlled trials of all adults combined, 14% on pregabalin and 7% on placebo stopped because of side effects. Dizziness (4%) and somnolence (4%) were the most frequent reasons.
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
6.1
Source text (exact source wording)
In premarketing controlled trials of all adult populations combined, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the pregabalin group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).
Interactions
Drugs
Pregabalin with opioids or other CNS depressants has been linked to serious, life-threatening or fatal respiratory depression. Additive effects on thinking and movement were seen with oxycodone, lorazepam or ethanol.
Name
Opioids and other CNS depressants (e.g., oxycodone, lorazepam)
Section
5.5; 7
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Source text (exact source wording)
5.5 Respiratory Depression
There is evidence from case reports, human studies, and animal studies associating pregabalin with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including pregabalin).
There is more limited evidence from case reports, animal studies, and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.
Multiple oral doses of pregabalin were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when pregabalin was co-administered with these drugs. No clinically important effects on respiration were seen.
There is evidence from case reports, human studies, and animal studies associating pregabalin with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including pregabalin).
There is more limited evidence from case reports, animal studies, and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.
Multiple oral doses of pregabalin were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when pregabalin was co-administered with these drugs. No clinically important effects on respiration were seen.
Patients taking ACE inhibitors may have a higher risk of angioedema.
Name
Angiotensin converting enzyme (ACE) inhibitors
Section
5.1
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Source text (exact source wording)
In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.
Taking pregabalin with a thiazolidinedione diabetes medicine raises the chance of weight gain and swelling.
Name
Thiazolidinedione antidiabetic agents (rosiglitazone, pioglitazone)
Section
5.7; Medication Guide
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Source text (exact source wording)
Higher frequencies of weight gain and peripheral edema were observed in patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. [Medication Guide: Avandia (rosiglitazone) or Actos (pioglitazone) for diabetes. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with pregabalin capsules.]
Reduced lower gut function (blockage, paralytic ileus, constipation) has been reported when pregabalin is combined with constipating medicines such as opioid pain medicines.
Name
Medicines that slow the lower gut (e.g., opioid analgesics)
Section
6.2
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Source text (exact source wording)
In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Pregabalin is mostly excreted unchanged in the urine, and no pharmacokinetic interactions were found with carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital or topiramate.
Name
Antiepileptic drugs (carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, topiramate)
Section
7
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Source text (exact source wording)
7 DRUG INTERACTIONS
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs [see Clinical Pharmacology (12)].
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs [see Clinical Pharmacology (12)].
Food and alcohol
Capsules can be taken with or without food.
Name
Food
Section
2.1
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Source text (exact source wording)
Pregabalin capsules are given orally with or without food.
Avoid alcohol while taking pregabalin; it can add to drowsiness and impair motor skills.
Name
Alcohol
Section
17; MedlinePlus
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display); MedlinePlus Pregabalin (https://medlineplus.gov/druginfo/meds/a605045.html), Last Revised - 05/15/2020
Source text (exact source wording)
Advise patients to avoid consuming alcohol while taking pregabalin, as pregabalin may potentiate the impairment of motor skills and sedating effects of alcohol. MedlinePlus: do not drink alcohol while taking pregabalin. Alcohol can add to the drowsiness caused by this medication.
Patient tips
Label medication guide
Take pregabalin exactly as prescribed, with or without food, and do not change your dose or stop suddenly without talking to your provider. Do not drive or do dangerous activities until you know how it affects you. Tell your provider about ACE inhibitors, rosiglitazone or pioglitazone, opioids, anxiety or sleep medicines. The most common side effects in adults are dizziness, weight gain, trouble concentrating, blurry vision, sleepiness, swelling of hands and feet and dry mouth.
Source
Medication Guide in DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Section
Medication Guide
Source text (exact source wording)
Pregabalin capsules may cause serious side effects including:
serious, even life-threatening, allergic reactions
swelling of your hands, legs and feet
suicidal thoughts or actions
dizziness and sleepiness
serious breathing problems
Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin capsules affect you. Ask your healthcare provider about when they will be okay to do these activities.
How should I take pregabalin capsules?
Take pregabalin capsules exactly as prescribed. Your healthcare provider will tell you how much pregabalin capsules to take and when to take it.
Pregabalin capsules may be taken with or without food.
Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
Do not stop taking pregabalin capsules without talking to your healthcare provider. If you stop taking pregabalin capsules suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking pregabalin capsules suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop pregabalin capsules slowly.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. Pregabalin capsules and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
angiotensin converting enzyme (ACE) inhibitors, which are used to treat many conditions, including high blood pressure. You may have a higher chance for swelling and hives if these medicines are taken with pregabalin capsules.
Avandia (rosiglitazone) or Actos (pioglitazone) for diabetes. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with pregabalin capsules.
any opioid pain medicine (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with pregabalin capsules.
any medicines that make you sleepy.
What are the possible side effects of pregabalin capsules?
Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away.
Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight.
Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.
Feeling “high”.
The most common side effects of pregabalin capsules in adults are: dizziness; weight gain; trouble concentrating; blurry vision; sleepiness; swelling of hands and feet; dry mouth
The most common side effects of pregabalin capsules in children are weight gain, increase in appetite, and sleepiness.
Pregabalin capsules caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking pregabalin capsules and tell your healthcare provider about any sores or skin problems.
serious, even life-threatening, allergic reactions
swelling of your hands, legs and feet
suicidal thoughts or actions
dizziness and sleepiness
serious breathing problems
Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how pregabalin capsules affect you. Ask your healthcare provider about when they will be okay to do these activities.
How should I take pregabalin capsules?
Take pregabalin capsules exactly as prescribed. Your healthcare provider will tell you how much pregabalin capsules to take and when to take it.
Pregabalin capsules may be taken with or without food.
Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
Do not stop taking pregabalin capsules without talking to your healthcare provider. If you stop taking pregabalin capsules suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking pregabalin capsules suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop pregabalin capsules slowly.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. Pregabalin capsules and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
angiotensin converting enzyme (ACE) inhibitors, which are used to treat many conditions, including high blood pressure. You may have a higher chance for swelling and hives if these medicines are taken with pregabalin capsules.
Avandia (rosiglitazone) or Actos (pioglitazone) for diabetes. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with pregabalin capsules.
any opioid pain medicine (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with pregabalin capsules.
any medicines that make you sleepy.
What are the possible side effects of pregabalin capsules?
Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away.
Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight.
Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.
Feeling “high”.
The most common side effects of pregabalin capsules in adults are: dizziness; weight gain; trouble concentrating; blurry vision; sleepiness; swelling of hands and feet; dry mouth
The most common side effects of pregabalin capsules in children are weight gain, increase in appetite, and sleepiness.
Pregabalin capsules caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking pregabalin capsules and tell your healthcare provider about any sores or skin problems.
Medlineplus
MedlinePlus says to take it as directed, that it may be habit forming, to keep taking it even when you feel well, not to stop suddenly (the dose is usually decreased over at least 1 week), to continue your normal diet, and not to drink alcohol.
Source
MedlinePlus Pregabalin (https://medlineplus.gov/druginfo/meds/a605045.html), Last Revised - 05/15/2020
Section
MedlinePlus
Source text (exact source wording)
Pregabalin comes as a capsule, an oral solution, and as an extended-release tablet to take by mouth. Pregabalin capsules and oral solution are usually taken with or without food two or three times a day. Take pregabalin at around the same time(s) every day.
Your doctor will probably start you on a low dose of pregabalin and may gradually increase your dose during the first week of treatment.
Take pregabalin exactly as directed. Pregabalin may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Continue to take pregabalin even if you feel well. Do not stop taking pregabalin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least 1 week.
Unless your doctor tells you otherwise, continue your normal diet.
do not drink alcohol while taking pregabalin. Alcohol can add to the drowsiness caused by this medication.
Your doctor will probably start you on a low dose of pregabalin and may gradually increase your dose during the first week of treatment.
Take pregabalin exactly as directed. Pregabalin may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Continue to take pregabalin even if you feel well. Do not stop taking pregabalin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least 1 week.
Unless your doctor tells you otherwise, continue your normal diet.
do not drink alcohol while taking pregabalin. Alcohol can add to the drowsiness caused by this medication.
When to call doctor
See the Medication Guide 'Stop taking... call your healthcare provider right away' signs and the MedlinePlus serious side effects list above.
Alternatives
Class source
https://medlineplus.gov/druginfo/meds/a605045.html (anticonvulsants)
Indication source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display section 1
Note
No recommendation of one over another.
Frequently asked questions
Question
What is pregabalin used for?
Answer
Pregabalin capsules are indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 1 month of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
Source section
1
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
Can I take it with food?
Answer
Pregabalin capsules are given orally with or without food.
Source section
2.1
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
What is the usual starting dose for adults?
Answer
For the adult indications dosing begins at 150 mg/day, except fibromyalgia and spinal cord injury where the recommended start is 75 mg two times a day (150 mg/day).
Source section
Highlights; 2.2-2.6
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
What if I miss a dose?
Answer
Take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time.
Source section
17
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
What are the common side effects?
Answer
The label's most common reactions in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (difficulty with concentration/attention).
Source section
Highlights; 6.1
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
Is pregabalin a controlled substance?
Answer
Yes. The label says pregabalin is a Schedule V controlled substance.
Source section
9.1
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
Can I stop pregabalin suddenly?
Answer
No. Withdraw gradually; the label says to taper over a minimum of 1 week because abrupt or rapid discontinuation can cause insomnia, nausea, headache, anxiety, sweating and diarrhea and may increase seizures.
Source section
5.4
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
Can I drink alcohol or drive?
Answer
The label advises avoiding alcohol and not driving, operating complex machinery or doing other hazardous activities until you know how pregabalin affects you.
Source section
17
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Question
Is breastfeeding recommended?
Answer
No. The label says breastfeeding is not recommended during treatment with pregabalin.
Source section
8.2
Source
DailyMed printer-friendly label Pregabalin Capsules (Aurobindo Pharma Limited), set ID 11034861-eef2-4996-8082-afc3c1769171, Revised: 4/2026 (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11034861-eef2-4996-8082-afc3c1769171&type=display)
Sources
- DailyMed printer-friendly label, Pregabalin Capsules (Aurobindo Pharma Limited) - CHOSEN
Set id: 11034861-eef2-4996-8082-afc3c1769171 · Label effective or revised date: Revised: 4/2026 · Dailymed version date: NOT RECORDED in this pass · Fetched at: 2026-11-03 · Sections used: Highlights, 1-5, 6.1, 6.2, 7, 8, 9.1, 10, 12.1, 16, 17, Medication Guide (read from full text via get_page_text) - MedlinePlus Pregabalin
Label effective or revised date: Last Revised - 05/15/2020 · Fetched at: 2026-11-03 · Sections used: full page - openFDA Drugs@FDA data, brand_name LYRICA
Label effective or revised date: openFDA last_updated 2026-10-30 · Fetched at: 2026-11-03 · Sections used: 5 results for LYRICA; first result NDA022488 (oral solution, 20MG/ML, Prescription, sponsor UPJOHN) - ALTERNATE 1: Pregabalin capsules, Unichem Laboratories Ltd (Unichem Pharmaceuticals (USA), Inc.)
Set id: 284f2c15-24ef-466b-8110-3c2e87483509 · Label effective or revised date: Revised: 4/2026 (Highlights); a trailing 'Revised: 5/2026' follows the package data · Dailymed version date: NOT RECORDED · Fetched at: 2026-11-03 · Sections used: revised-date lines only (read from full text) - ALTERNATE 2: Pregabalin capsules, Solco Healthcare US, LLC
Set id: 085db834-3735-40d9-ac67-f9dbb82390c5 · Label effective or revised date: NOT READ from label text in this pass (earlier header read listed it among the tied 4/2026 labels) · Dailymed version date: NOT RECORDED · Fetched at: 2026-11-03 · Sections used: none
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug