Gabapentin
Generic name: gabapentin · Brand names: Neurontin, Gralise, Horizant
Quick facts
Drug class
Value
anticonvulsant (MedlinePlus: 'Gabapentin is in a class of medications called anticonvulsants.'). openFDA returned no pharmacologic class (EPC) for gabapentin.
Source
MedlinePlus Gabapentin (Last Revised - 05/15/2020)
Source url
https://medlineplus.gov/druginfo/meds/a694007.html
Rx or otc
Value
Rx only
Source
DailyMed label: 'Rx only' (prescription medicine, Medication Guide)
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Controlled schedule
Value
Not a controlled substance (federal label statement)
Section
9.1 Controlled Substance
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source text (exact source wording)
Gabapentin is not a controlled substance.
Forms and strengths
Text
Capsules: 100 mg, 300 mg, 400 mg
Section
3 DOSAGE FORMS AND STRENGTHS
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Generic available
Value
Yes. Chosen label is an ANDA (ANDA075350) generic capsule label.
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Common use one line
Treats nerve pain after shingles and, with other medicines, certain seizures.
Scope note
Covers gabapentin CAPSULES (the Teva label is capsules only). Gabapentin tablets and oral solution have separate labels with their own text and are NOT covered here; MedlinePlus covers capsules, tablets and solution together. Horizant (extended-release) and Gralise are different products.
What it is used for
Gabapentin capsules treat nerve pain after shingles (postherpetic neuralgia) in adults. They are also added to other medicines to treat partial onset seizures in adults and in children 3 years and older with epilepsy.
Section
1 INDICATIONS AND USAGE
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Gabapentin capsules are indicated for: Management of postherpetic neuralgia in adults. Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
How it works
The exact way gabapentin works for pain and seizures is unknown. It is related to the brain chemical GABA but does not act on GABA. It binds to part of certain calcium channels, but how that helps is unknown.
Section
12.1 Mechanism of Action
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation. In vitro studies have shown that gabapentin binds with high-affinity to the α2δ subunit of voltage-activated calcium channels; however, the relationship of this binding to the therapeutic effects of gabapentin is unknown.
Dosage: adults
For nerve pain after shingles, the dose may start at 300 mg on Day 1, 600 mg/day on Day 2 and 900 mg/day on Day 3, then be raised as needed up to 1,800 mg/day. For epilepsy in patients 12 and older, the starting dose is 300 mg three times a day, with a maintenance dose of 300 mg to 600 mg three times a day. Doses should not be more than 12 hours apart. It can be taken with or without food, swallowed whole with water. Any dose reduction or stop should be gradual over a minimum of 1 week. Dosing is set by the prescriber.
Section
2.1 Dosage for Postherpetic Neuralgia; 2.2 Patients 12 Years of Age and Above; 2.5 Administration Information
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
In adults with postherpetic neuralgia, gabapentin capsules may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1,800 mg/day (600 mg three times a day). Epilepsy, patients 12 years of age and above: The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin capsules are 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been administered in long-term clinical studies. Administer gabapentin capsules three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours. Administer gabapentin capsules orally with or without food. Gabapentin capsules should be swallowed whole with water. If the gabapentin capsules dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
Dosage: children
For epilepsy in children 3 to 11 years the starting dose is 10 mg/kg/day to 15 mg/kg/day in three divided doses. The maintenance dose is 40 mg/kg/day for ages 3 to 4 and 25 mg/kg/day to 35 mg/kg/day for ages 5 to 11. Safety and effectiveness for nerve pain after shingles in children, and for seizures under age 3, have not been established.
Section
2.2 Pediatric Patients Age 3 to 11 Years; 8.4 Pediatric Use
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin capsules in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin capsules in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Dosages up to 50 mg/kg/day have been administered in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours. Safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. Safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established
Dosage adjustments
Drug interaction caps
Gabapentin should be taken at least 2 hours after Maalox. Patients also taking morphine may need a gabapentin dose adjustment.
Section
7.3 Maalox; 5.4
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
It is recommended that gabapentin be taken at least 2 hours following Maalox administration. patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations and may require dose adjustment
Kidney
The dose must be lowered in patients 12 and older with reduced kidney function or on hemodialysis. For example, the total daily dose range is 900 to 3,600 mg/day at a creatinine clearance of 60 or more and 400 to 1,400 mg/day at more than 30 to 59. Below 15, the daily dose is reduced in proportion to creatinine clearance. It has not been studied in children under 12 with kidney problems.
Section
2.3 Dosage Adjustment in Patients with Renal Impairment (Table 1)
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows. TABLE 1. Gabapentin Capsules Dosage Based on Renal Function (Creatinine Clearance, mL/min: Total Daily Dose Range, mg/day): ≥60: 900 to 3,600 (300 TID, 400 TID, 600 TID, 800 TID, 1,200 TID); >30 to 59: 400 to 1,400 (200 BID, 300 BID, 400 BID, 500 BID, 700 BID); >15 to 29: 200 to 700 (200 QD, 300 QD, 400 QD, 500 QD, 700 QD); 15: 100 to 300 (100 QD, 125 QD, 150 QD, 200 QD, 300 QD); Post-Hemodialysis Supplemental Dose (mg): 125, 150, 200, 250, 350. TID = Three times a day; BID = Two times a day; QD = Single daily dose. For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). The use of gabapentin capsules in patients less than 12 years of age with compromised renal function has not been studied.
Liver
Section
12.3 Pharmacokinetics
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Elderly
Older adults are more likely to have reduced kidney function, so the dose is chosen with care and adjusted by creatinine clearance.
Section
2.4 Dosage in Elderly
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
Missed dose
Take a missed dose as soon as you remember. If it is almost time for the next dose, skip it. Do not take a double dose. (The DailyMed label has no missed-dose section.)
Section
What should I do if I forget a dose?
Source
MedlinePlus Gabapentin (Last Revised - 05/15/2020)
Source url
https://medlineplus.gov/druginfo/meds/a694007.html
Source text (exact source wording)
If you forget to take gabapentin capsules, tablets, or oral solution, take the missed dose as soon as you remember it. However, if it is almost time for the next dose or if you forget to take gabapentin extended-release tablets, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
Overdose has caused double vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy and diarrhea. Fatal respiratory depression has been reported. Call poison control at 1-800-222-1222.
Section
10 OVERDOSAGE
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Acute oral overdoses of gabapentin have been reported. Symptoms have included double vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy, and diarrhea. Fatal respiratory depression has been reported with gabapentin overdose, alone and in combination with other CNS depressants. Gabapentin can be removed by hemodialysis. If overexposure occurs, call your poison control center at 1-800-222-1222.
Storage
Store at 20° to 25°C (68° to 77°F); trips to 15° to 30°C (59° to 86°F) are allowed. Keep in a tight, light-resistant container. This is the labeler's text; MedlinePlus says to keep capsules away from excess heat and moisture, and to store the oral solution in the refrigerator.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (Teva label)
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Boxed warning
The label has no boxed warning.
Present
NONE (no boxed warning section found in the label text)
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Contraindications
Do not use gabapentin if you are allergic to it or any of its ingredients.
Section
4 CONTRAINDICATIONS
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Warnings and precautions
A serious, sometimes fatal allergic reaction (DRESS) can occur, with fever, rash or swollen glands and other organ problems. Gabapentin should be stopped if no other cause is found.
Heading
DRESS / multiorgan hypersensitivity
Section
5.1
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with gabapentin. Some of these reactions have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Gabapentin capsules should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Severe allergic reactions can happen after the first dose or at any time. Signs include trouble breathing and swelling of the lips, throat and tongue. Stop the medicine and get medical care right away.
Heading
Anaphylaxis and angioedema
Section
5.2
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Gabapentin capsules can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin capsules and seek immediate medical care should they experience signs or symptoms of anaphylaxis or angioedema.
Do not drive or use complex machinery until you know how gabapentin affects you.
Heading
Driving and operating machinery
Section
5.3
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Patients taking gabapentin capsules should not drive until they have gained sufficient experience to assess whether gabapentin impairs their ability to drive. patients should be advised not to operate complex machinery until they have gained sufficient experience on gabapentin to assess whether gabapentin impairs their ability to perform such tasks.
Gabapentin can cause sleepiness and dizziness. In shingles-nerve-pain trials, 21% of gabapentin patients had sleepiness versus 5% on placebo, and 28% had dizziness versus 8% on placebo.
Heading
Somnolence/sedation and dizziness
Section
5.4
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
In these trials somnolence, ataxia and fatigue were common adverse reactions leading to discontinuation of gabapentin in patients older than 12 years of age, with 1.2%, 0.8% and 0.6% discontinuing for these events, respectively. During the controlled trials in patients with post-herpetic neuralgia, somnolence, and dizziness were reported at a greater rate compared to placebo in patients receiving gabapentin, in dosages up to 3,600 mg per day: i.e., 21% in gabapentin-treated patients versus 5% in placebo-treated patients for somnolence and 28% in gabapentin-treated patients versus 8% in placebo-treated patients for dizziness.
Antiepileptic drugs, including gabapentin, raise the risk of suicidal thoughts or behavior. The rate was 0.43% with the drugs versus 0.24% with placebo, about one added case for every 530 patients treated. Watch for new or worse depression or unusual mood or behavior changes.
Heading
Suicidal behavior and ideation
Section
5.5
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Antiepileptic drugs (AEDs), including gabapentin capsules, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 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.
Do not stop suddenly, because seizures may increase. The dose should be tapered over at least one week. Withdrawal symptoms have been seen.
Heading
Abrupt or rapid discontinuation
Section
5.6
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. When gabapentin capsules are being discontinued, the dose should be tapered over at least a one-week period. After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed in some patients.
In epilepsy studies the rate of status epilepticus was 0.6% (3 of 543) with gabapentin and 0.5% (2 of 378) with placebo.
Heading
Status epilepticus
Section
5.7
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
In the placebo-controlled epilepsy studies in patients > 12 years of age, the incidence of status epilepticus in patients receiving gabapentin was 0.6% (3 of 543) versus 0.5% in patients receiving placebo (2 of 378).
Gabapentin has been linked to serious, life-threatening or fatal slowed breathing when used with opioids or other CNS depressants, or in people with breathing problems. Patients should be monitored and a low starting dose considered.
Heading
Respiratory depression
Section
5.8
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when coadministered with CNS depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe gabapentin capsules with another CNS depressant, particularly an opioid, or to prescribe gabapentin capsules to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating gabapentin capsules at a low dose.
In children 3 to 12 with epilepsy, gabapentin was linked to emotional lability (6% vs 1.3% placebo), hostility (5.2% vs 1.3%), hyperkinesia (4.7% vs 2.9%) and thought disorder (1.7% vs 0%).
Heading
Neuropsychiatric reactions in children 3 to 12
Section
5.9
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Gabapentin use in pediatric patients with epilepsy 3 to 12 years of age is associated with the occurrence of CNS related adverse reactions. In controlled clinical epilepsy trials in pediatric patients 3 to 12 years of age, the incidence of these adverse reactions was: emotional lability 6% (gabapentin-treated patients) versus 1.3% (placebo-treated patients); hostility 5.2% versus 1.3%; hyperkinesia 4.7% versus 2.9%; and thought disorder 1.7% versus 0%.
Gabapentin increased a type of pancreatic tumor in rats. The clinical significance is unknown.
Heading
Tumorigenic potential
Section
5.10
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in rats. The clinical significance of this finding is unknown.
Pregnancy and breastfeeding
Pregnancy
Available human data have not shown an increased risk of major birth defects or miscarriage. Animal studies showed harm to developing offspring at doses similar to or lower than those used clinically. Long use with opioids near delivery may raise the risk of neonatal withdrawal. A pregnancy registry exists (1-888-233-2334).
Section
8.1 Pregnancy
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
The totality of available data from published prospective and retrospective cohort studies pertaining to gabapentin use during pregnancy has not indicated an increased risk of major birth defects or miscarriage. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically. Postmarketing data suggest that extended gabapentin use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334.
Breastfeeding
Gabapentin passes into breast milk. Its effects on the infant and on milk production are unknown. Weigh breastfeeding benefits against the mother's need for the drug.
Section
8.2 Lactation
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Gabapentin is secreted in human milk following oral administration. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition.
Medlineplus
Tell your doctor if you are pregnant, plan to be, or are breastfeeding.
Section
What special precautions should I follow?
Source
MedlinePlus Gabapentin (Last Revised - 05/15/2020)
Source url
https://medlineplus.gov/druginfo/meds/a694007.html
Source text (exact source wording)
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking gabapentin, call your doctor.
Side effects
Common
For nerve pain after shingles, the label's most common reactions were dizziness, somnolence (sleepiness) and peripheral edema (swelling). For epilepsy in patients over 12 they were somnolence, dizziness, ataxia (poor coordination), fatigue and nystagmus (unusual eye movements). In children 3 to 12 they were viral infection, fever, nausea and/or vomiting, somnolence and hostility. For example, in the shingles-pain trials dizziness occurred in 28% of gabapentin patients versus 8% on placebo and somnolence in 21% versus 5%.
Section
6.1 Clinical Trials Experience
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Threshold
The label states 'most common' as reactions 'not seen at an equivalent frequency among placebo-treated patients'; it gives no numeric threshold for the 'most common' lists. Tables list reactions in at least 1% (adult tables) or at least 2% (pediatric table) of gabapentin patients that were numerically more frequent than placebo.
Medication guide
The Medication Guide lists lack of coordination, viral infection, trouble speaking, tremor, swelling of legs and feet, tiredness, fever, drowsiness, nausea and vomiting, jerky movements, double vision and unusual eye movement as the most common side effects.
Section
Medication Guide: What are the possible side effects
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
The most common side effects of gabapentin capsules include: lack of coordination, viral infection, difficulty with speaking, tremor, swelling, usually of legs and feet, feeling tired, fever, feeling drowsy, nausea and vomiting, jerky movements, difficulty with coordination, double vision, unusual eye movement
Source text (exact source wording)
Postherpetic Neuralgia: The most common adverse reactions associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. Epilepsy with Partial Onset Seizures (Adjunctive Therapy): The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in patients > 12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus. The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients, were viral infection, fever, nausea and/or vomiting, somnolence, and hostility. Table 3 (postherpetic neuralgia; gabapentin N=336 vs placebo N=227; % of patients; adverse reactions in at least 1% of gabapentin patients and numerically more frequent than placebo): Asthenia 6 vs 5; Infection 5 vs 4; Accidental injury 3 vs 1; Diarrhea 6 vs 3; Dry mouth 5 vs 1; Constipation 4 vs 2; Nausea 4 vs 3; Vomiting 3 vs 2; Peripheral edema 8 vs 2; Weight gain 2 vs 0; Hyperglycemia 1 vs 0; Dizziness 28 vs 8; Somnolence 21 vs 5; Ataxia 3 vs 0; Abnormal thinking 3 vs 0; Abnormal gait 2 vs 0; Incoordination 2 vs 0; Pharyngitis 1 vs 0; Amblyopia 3 vs 1 (reported as blurred vision); Conjunctivitis 1 vs 0; Diplopia 1 vs 0; Otitis media 1 vs 0. Table 4 (epilepsy, add-on, patients >12 years; gabapentin N=543 vs placebo N=378; %; at least 1% and numerically more common than placebo): Fatigue 11 vs 5; Increased weight 3 vs 2; Back pain 2 vs 1; Peripheral edema 2 vs 1; Vasodilatation 1 vs 0; Dyspepsia 2 vs 1; Dry mouth or throat 2 vs 1; Constipation 2 vs 1; Dental abnormalities 2 vs 0; Somnolence 19 vs 9; Dizziness 17 vs 7; Ataxia 13 vs 6; Nystagmus 8 vs 4; Tremor 7 vs 3; Dysarthria 2 vs 1; Amnesia 2 vs 0; Depression 2 vs 1; Abnormal thinking 2 vs 1; Abnormal coordination 1 vs 0; Pharyngitis 3 vs 2; Coughing 2 vs 1; Abrasion 1 vs 0; Impotence 2 vs 1; Diplopia 6 vs 2; Amblyopia 4 vs 1 (often described as blurred vision). Table 5 (pediatric epilepsy, ages 3 to 12; gabapentin N=119 vs placebo N=128; %; at least 2% and numerically more common than placebo): Viral infection 11 vs 3; Fever 10 vs 3; Increased weight 3 vs 1; Fatigue 3 vs 2; Nausea and/or vomiting 8 vs 7; Somnolence 8 vs 5; Hostility 8 vs 2; Emotional lability 4 vs 2; Dizziness 3 vs 2; Hyperkinesia 3 vs 1; Bronchitis 3 vs 1; Respiratory infection 3 vs 1.
Less common
The label does not set a separate cutoff for less common reactions. Examples in the trial tables at 1% include hyperglycemia, conjunctivitis, diplopia and otitis media in the shingles-pain trials, and vasodilatation, abnormal coordination and abrasion in the adult epilepsy trials.
Section
6.1 Clinical Trials Experience (Tables 3, 4, 5)
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
See the 'common' field: the label does not separate 'common' from 'less common' by a numeric cutoff; all listed table reactions are reported in the 'common' source_text with the placebo comparison. Reactions in Tables 3 and 4 with 1% to 2% incidence in gabapentin patients (examples): Hyperglycemia 1 vs 0; Pharyngitis 1 vs 0; Conjunctivitis 1 vs 0; Diplopia 1 vs 0; Otitis media 1 vs 0 (postherpetic neuralgia, Table 3); Vasodilatation 1 vs 0; Abnormal coordination 1 vs 0; Abrasion 1 vs 0 (epilepsy, Table 4).
Serious
Label
Serious reactions in the label include severe allergic reactions (DRESS, anaphylaxis, angioedema), suicidal thoughts, seizures when stopped suddenly, slowed breathing, and serious skin reactions such as Stevens-Johnson syndrome. Postmarketing reports include jaundice, low sodium and muscle breakdown (rhabdomyolysis).
Section
5 WARNINGS AND PRECAUTIONS; 6.2 Postmarketing Experience
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
DRESS/multiorgan hypersensitivity; anaphylaxis and angioedema; suicidal behavior and ideation; increased risk of seizures with abrupt discontinuation; status epilepticus; respiratory depression; neuropsychiatric adverse reactions in pediatric patients 3 to 12 years of age. Postmarketing: jaundice; elevated creatine kinase, elevated liver function tests; hyponatremia; rhabdomyolysis; movement disorder; agitation; angioedema, bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome. There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking gabapentin with opioids or other CNS depressants, or in the setting of underlying respiratory impairment.
Medlineplus
MedlinePlus says to call your doctor right away for these symptoms.
Section
What side effects can this medication cause?
Source
MedlinePlus Gabapentin (Last Revised - 05/15/2020)
Source url
https://medlineplus.gov/druginfo/meds/a694007.html
Source text (exact source wording)
Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately: rash; itching; swelling of the face, throat, tongue, lips, or eyes; hoarseness; difficulty swallowing or breathing; seizures; difficulty breathing; bluish-tinged skin, lips, or fingernails; confusion; or extreme sleepiness
Led to discontinuation
In shingles-pain trials, 16% of gabapentin patients and 9% of placebo patients stopped because of side effects, most often dizziness, somnolence and nausea. In epilepsy trials about 7% of patients over 12 and about 7% of children 3 to 12 stopped. Over 12, the most common reasons were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea and/or vomiting (0.6%) and dizziness (0.6%). In children they were emotional lability (1.6%), hostility (1.3%) and hyperkinesia (1.1%).
Section
6.1 Clinical Trials Experience
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received gabapentin and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction. The adverse reactions that most frequently led to withdrawal in gabapentin-treated patients were dizziness, somnolence, and nausea. Approximately 7% of the 2,074 patients > 12 years of age and approximately 7% of the 449 pediatric patients 3 to 12 years of age who received gabapentin in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with withdrawal in patients > 12 years of age were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea and/or vomiting (0.6%), and dizziness (0.6%). The adverse reactions most commonly associated with withdrawal in pediatric patients were emotional lability (1.6%), hostility (1.3%), and hyperkinesia (1.1%).
Reporting
You may report side effects to FDA at 1-800-FDA-1088 (Medication Guide).
Interactions
Drugs
Slowed breathing and sedation, sometimes fatal, have been reported with opioids. Gabapentin lowers hydrocodone exposure. Watch morphine users for signs of CNS depression.
Name
Opioids (morphine, hydrocodone, oxycodone, buprenorphine)
Section
7.1 Opioids
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine). Coadministration of gabapentin with hydrocodone decreases hydrocodone exposure. When gabapentin is administered with morphine, patients should be observed for signs of CNS depression, such as somnolence, sedation and respiratory depression.
Other sedating drugs may add to sleepiness; patients should be watched for CNS depression.
Name
Other CNS depressants
Section
5.4; 5.8
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence and sedation, when gabapentin capsules are used with other drugs with sedative properties because of potential synergy.
An antacid with magnesium and aluminum hydroxides lowered gabapentin absorption by about 20%. Take gabapentin at least 2 hours after it.
Name
Maalox (aluminum hydroxide, magnesium hydroxide)
Section
7.3
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid (Maalox®) containing magnesium and aluminum hydroxides. It is recommended that gabapentin be taken at least 2 hours following Maalox administration.
Gabapentin does not interfere with the metabolism of commonly used antiepileptic drugs.
Name
Other antiepileptic drugs
Section
7.2
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs
Some urine protein dipstick tests can give false positives; a more specific lab method is recommended.
Name
Urine protein dipstick tests
Section
7.4 Drug/Laboratory Test Interactions
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Because false positive readings were reported with the Ames N-Multistix SG® dipstick test for urinary protein when gabapentin was added to other antiepileptic drugs, the more specific sulfosalicylic acid precipitation procedure is recommended to determine the presence of urine protein.
Food and alcohol
Do not drink alcohol or take other sleepy-making medicines with gabapentin without talking to your healthcare provider first. They can make sleepiness or dizziness worse.
Name
Alcohol
Section
Medication Guide: What should I avoid while taking gabapentin capsules?
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Gabapentin capsules can be taken with or without food. Food has only a slight effect on absorption.
Name
Food
Section
2.5 Administration Information; 12.3
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Administer gabapentin capsules orally with or without food. Food has only a slight effect on the rate and extent of absorption of gabapentin (14% increase in AUC and Cmax).
Name
Grapefruit
Other
MedlinePlus says NSAIDs such as ibuprofen and naproxen may interact with gabapentin. The DailyMed label does not list NSAIDs; kept as a separate source note.
Name
NSAIDs (nonprescription)
Section
What special precautions should I follow?
Source
MedlinePlus Gabapentin (Last Revised - 05/15/2020)
Source url
https://medlineplus.gov/druginfo/meds/a694007.html
Source text (exact source wording)
the following nonprescription products may interact with gabapentin: nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve).
Patient tips
Label medication guide
Do not stop suddenly. Take with or without food and swallow whole with water. Wait at least 2 hours after antacids with aluminum and magnesium. Do not drive until you know how it affects you. Call your healthcare provider right away for new or worse depression, suicidal thoughts, anxiety, agitation, trouble sleeping or other mood or behavior changes.
Section
Medication Guide
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c7f21eaa-68ee-420c-9c98-e997cc73a297&type=display
Source text (exact source wording)
Do not stop taking gabapentin capsules without first talking to your healthcare provider. Stopping gabapentin capsules suddenly can cause serious problems. Gabapentin capsules can be taken with or without food. Swallow gabapentin capsules whole with water. If you take an antacid containing aluminum and magnesium, such as Maalox, Mylanta, Gelusil, Gaviscon, or Di-Gel, you should wait at least 2 hours before taking your next dose of gabapentin capsules. Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin capsules affect you. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.
Medlineplus
Gabapentin helps control but does not cure your condition. Keep taking it even if you feel well and do not stop without talking to your doctor, who may lower the dose gradually over at least a week.
Section
How should this medicine be used?
Source
MedlinePlus Gabapentin (Last Revised - 05/15/2020)
Source url
https://medlineplus.gov/druginfo/meds/a694007.html
Source text (exact source wording)
Gabapentin may help to control your condition but will not cure it. Continue to take gabapentin even if you feel well. Do not stop taking gabapentin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. Your doctor may decrease your dose gradually over at least a week.
Alternatives
Class
anticonvulsant (MedlinePlus)
Class source
MedlinePlus Gabapentin; openFDA returned no EPC class for gabapentin
Class source url
https://medlineplus.gov/druginfo/meds/a694007.html
Note
No recommendation.
Frequently asked questions
Question
What is gabapentin used for?
Answer
Gabapentin capsules treat nerve pain after shingles (postherpetic neuralgia) in adults. They are also used with other medicines for partial onset seizures in adults and in children 3 years and older with epilepsy.
Source section
1 INDICATIONS AND USAGE
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Question
Can I take gabapentin with food?
Answer
Yes. The label says gabapentin capsules are taken with or without food and swallowed whole with water.
Source section
2.5 Administration Information
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Question
What should I do 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 one. Do not take a double dose.
Source section
What should I do if I forget a dose?
Source
MedlinePlus Gabapentin
Question
Can I drink alcohol with gabapentin?
Answer
The Medication Guide says not to drink alcohol or take other medicines that cause sleepiness or dizziness while taking gabapentin without first talking with your healthcare provider, because it may make sleepiness or dizziness worse.
Source section
Medication Guide
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Question
What are the most common side effects?
Answer
For nerve pain after shingles the label lists dizziness, somnolence and peripheral edema. For epilepsy in patients over 12 it lists somnolence, dizziness, ataxia, fatigue and nystagmus. In children 3 to 12 it lists viral infection, fever, nausea and/or vomiting, somnolence and hostility.
Source section
6.1 Clinical Trials Experience
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Question
Is gabapentin safe in pregnancy or breastfeeding?
Answer
Available human data have not shown an increased risk of major birth defects or miscarriage, but animal studies showed harm at doses similar to or lower than those used clinically. Gabapentin is secreted in human milk and the effects on the infant and milk production are unknown. Talk to your doctor.
Source section
8.1 Pregnancy; 8.2 Lactation
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Question
What should I not combine with gabapentin?
Answer
Opioids and other sedating drugs can cause slowed breathing and sleepiness. An antacid with magnesium and aluminum hydroxides (Maalox) should be taken at least 2 hours before gabapentin.
Source section
7 DRUG INTERACTIONS; 5.8
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Question
Should I stop gabapentin when I feel well?
Answer
No. The Medication Guide says not to stop without talking to your healthcare provider, because stopping suddenly can cause serious problems, including seizures that will not stop in people with epilepsy.
Source section
Medication Guide
Source
DailyMed label, Teva Pharmaceuticals, Inc. gabapentin capsules, set ID c7f21eaa-68ee-420c-9c98-e997cc73a297
Sources
- DailyMed gabapentin capsules, Teva Pharmaceuticals, Inc. (chosen label)
Set id: c7f21eaa-68ee-420c-9c98-e997cc73a297 · Label effective or revised date: Revised: 6/2026 (Rev. C 6/2026) · Dailymed version date: Jul 24, 2026 (DailyMed list publish date) · Fetched at: 2026-11-02 · Sections used: 1-10, 12.1, 12.3, 16, 17, Medication Guide - MedlinePlus Gabapentin
Label effective or revised date: Last Revised - 05/15/2020 · Fetched at: 2026-11-02 · Sections used: all patient sections - openFDA drug label API (class)
Label effective or revised date: API returned 'Nothing to count' (no EPC class for gabapentin) · Fetched at: 2026-11-02 · Sections used: none - Drugs@FDA
Label effective or revised date: NOT FOUND (not searched) · Fetched at: 2026-11-02 · 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