Topiramate

Q: What is topiramate used for?

The label lists treating certain seizures (initial monotherapy for patients 2 years of age and older, and adjunctive therapy for patients 2 years of age and older) and preventing migraine in patients 12 years of age and older. MedlinePlus notes it is used to prevent migraines, not to relieve the pain once a migraine starts.

Q: Can I take topiramate with food?

Yes. The label says the tablets can be taken without regard to meals, and the tablets should not be broken because of the bitter taste.

Q: What should I do if I miss a dose?

The label text read gives no missed-dose instructions. MedlinePlus says for tablets, sprinkle capsules or solution, to take the missed dose as soon as you remember, but if it is less than 6 hours before your next dose, to skip the missed dose, and not to take a double dose.

Q: Can I drink alcohol with topiramate?

The label says to use extreme caution if topiramate is used with alcohol and other CNS depressants. MedlinePlus says to tell your doctor if you drink alcohol, and that your doctor may tell you not to drink alcohol while taking other topiramate products.

Q: What are the most common side effects?

For epilepsy, the label lists these as most common (at least 10% more frequent than placebo or low-dose topiramate): paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever. For migraine (at least 5% more frequent than placebo): paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.

Q: Is topiramate safe in pregnancy or while breastfeeding?

The label says topiramate can cause fetal harm, with an increased risk of birth defects including cleft lip and/or cleft palate and of babies being small for gestational age. It should be used during pregnancy only if the potential benefit outweighs the potential risk. It is excreted in human milk, and diarrhea and somnolence have been reported in breastfed infants. MedlinePlus says to call your doctor right away if you become pregnant, but not to stop taking topiramate before talking to your doctor.

Q: Does topiramate affect birth control?

The label says there may be decreased contraceptive efficacy and increased breakthrough bleeding, and that efficacy can be decreased even without breakthrough bleeding. Patients should report any change in bleeding patterns, and women of childbearing potential who are not planning a pregnancy should use effective contraception.

Q: Should I stop topiramate when I feel well?

No. MedlinePlus says to continue taking it even if you feel well and not to stop without talking to your doctor, because suddenly stopping may cause severe seizures. The label says antiepileptic drugs, including topiramate, should be gradually withdrawn.

Generic name: topiramate · Brand names: Topamax (tablets and sprinkle capsules), Eprontia (oral solution, not covered), Qudexy XR (extended-release capsule, not covered), Trokendi XR (extended-release capsule, not covered)

Quick facts

Drug class

MedlinePlus calls it an anticonvulsant. The label calls it a carbonic anhydrase inhibitor and discusses it as an antiepileptic drug. openFDA returned no pharmacologic class (EPC) for topiramate in two searches.

Source

DailyMed Sun label 5.15, 7.2, 5.5; MedlinePlus

Rx or otc

Rx (label: See Medication Guide; DailyMed 'Rx only' not read separately)

Forms and strengths

Tablets, USP, film-coated: 25 mg white (coded S / 707); 50 mg yellow (S / 710); 100 mg yellow (S / 711); 200 mg brown (S / 712). Source: Section 3, DailyMed Sun label
Other forms exist (sprinkle capsule, extended-release capsules, oral solution) and are not covered in this record

Generic available

Value

Yes; many ANDA tablet labels on DailyMed (Sun, Zydus, Glenmark, Unichem, Aurobindo and others)

Source

DailyMed list https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=topiramate

Common use one line

Anticonvulsant used for certain seizures and to prevent migraine (Section 1).

What it is used for

Topiramate tablets are used alone as a first treatment for partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. They are used as add-on therapy for partial-onset seizures, primary generalized tonic-clonic seizures and seizures linked to Lennox-Gastaut syndrome in patients 2 years of age and older. They are also used to prevent migraine in patients 12 years of age and older.

Section

1 INDICATIONS AND USAGE

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

1.1 Monotherapy Epilepsy: Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy: Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. 1.3 Migraine: Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.

How it works

The label says the exact way topiramate works for seizures and migraine prevention is unknown. Laboratory studies suggest four effects: it blocks voltage-dependent sodium channels, boosts the calming brain chemical GABA at some GABA-A receptors, blocks the AMPA/kainate type of glutamate receptor, and inhibits the enzyme carbonic anhydrase.

Section

12.1 Mechanism of Action

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

The precise mechanisms by which topiramate exerts its anticonvulsant and preventive migraine effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and the preventive treatment of migraine. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.

Dosage: adults

For seizure monotherapy in adults and children 10 years of age and older the recommended dose is 400 mg/day in two divided doses, reached over 6 weeks starting at 25 mg twice daily. For adjunctive therapy in adults the total daily dose is 200 to 400 mg/day in two divided doses (400 mg/day for primary generalized tonic-clonic seizures), starting at 25 to 50 mg/day. For migraine prevention the recommended dose is 100 mg/day in two divided doses, titrated over 4 weeks. Tablets can be taken without regard to meals and should not be broken because of the bitter taste.

Section

2.1; 2.2; 2.3; 2.4

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

2.1 Dosing in Monotherapy Epilepsy, Adults and Pediatric Patients 10 Years of Age and Older: The recommended dose for topiramate monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. The dose should be achieved by titration according to the following schedule (Table 1): Week 1 25 mg morning, 25 mg evening; Week 2 50 mg, 50 mg; Week 3 75 mg, 75 mg; Week 4 100 mg, 100 mg; Week 5 150 mg, 150 mg; Week 6 200 mg, 200 mg. || 2.2 Dosing in Adjunctive Therapy Epilepsy, Adults (17 Years of Age and Older): The recommended total daily dose of topiramate as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. Topiramate should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures. || 2.3 Dosing for the Preventive Treatment of Migraine: The recommended total daily dose of topiramate as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). The recommended titration rate for topiramate for the preventive treatment of migraine is as follows: Week 1 none morning, 25 mg evening; Week 2 25 mg, 25 mg; Week 3 25 mg, 50 mg; Week 4 50 mg, 50 mg. Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used. || 2.4 Administration Information: Topiramate tablets can be taken without regard to meals. Because of the bitter taste, tablets should not be broken.

Dosage: children

Children 2 to 9 years of age are dosed by weight in monotherapy, starting at 25 mg/day nightly for the first week, with maintenance doses in Table 2. For adjunctive therapy in children 2 to 16 years of age the recommended total daily dose is approximately 5 to 9 mg/kg/day in two divided doses and should not exceed 400 mg/day. For migraine prevention in patients 12 years of age and older it is 100 mg/day in two divided doses. Safety and effectiveness were not established below 2 years of age for monotherapy epilepsy or below 12 years of age for migraine prevention.

Section

2.1; 2.2; 2.3; 8.4

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

2.1 Pediatric Patients 2 to 9 Years of Age (monotherapy epilepsy): Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of topiramate is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25 to 50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2). Table 2 (minimum maintenance dose / maximum maintenance dose, mg/day, administered in two equally divided doses): Up to 11 kg 150 / 250; 12 to 22 kg 200 / 300; 23 to 31 kg 200 / 350; 32 to 38 kg 250 / 350; Greater than 38 kg 250 / 400. || 2.2 Pediatric Patients 2 to 16 Years of Age (adjunctive epilepsy): The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome. The total daily dose should not exceed 400 mg/day. || 2.3: The recommended total daily dose of topiramate as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses. || 8.4 Pediatric Use: Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy. Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine.

Dosage adjustments

Drug interaction caps

The label gives no fixed dose caps. A dose adjustment may be needed with phenytoin or carbamazepine, the topiramate dose may need to be decreased when HCTZ is added, and lithium levels should be monitored with high-dose topiramate.

Section

7.1; 7.5; 7.7

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

7.1 Antiepileptic Drugs: Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. A dosage adjustment may be needed [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)]. || 7.5 Hydrochlorothiazide (HCTZ): Topiramate Cmax and AUC increased when HCTZ was added to topiramate. The clinical significance of this change is unknown. The addition of HCTZ to topiramate may require a decrease in the topiramate dose [see Clinical Pharmacology (12.3)]. || 7.7 Lithium: An increase in systemic exposure of lithium following topiramate doses of up to 600 mg/day can occur. Lithium levels should be monitored when coadministered with high-dose topiramate [see Clinical Pharmacology (12.3)].

Kidney

With kidney impairment (creatinine clearance less than 70 mL/min/1.73 m 2), one-half of the usual adult dose is recommended. A supplemental dose may be needed during hemodialysis.

Section

2.5; 2.6; 8.6

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

2.5 Dosing in Patients with Renal Impairment: In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m 2), one-half of the usual adult dose of topiramate is recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. || 2.6 Dosing in Patients Undergoing Hemodialysis: To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. || 8.6 Renal Impairment: The clearance of topiramate is reduced in patients with moderate (creatinine clearance 30 to 69 mL/min/1.73 m 2) and severe (creatinine clearance <30 mL/min/1.73 m 2) renal impairment. A dosage adjustment is recommended in patients with moderate or severe renal impairment [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].

Liver

Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. The label text read gives no specific liver dose adjustment.

Section

12.3 Specific Populations: Hepatic Impairment

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Hepatic Impairment: Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. (Section 12.3, Specific Populations)

Elderly

No age-related differences in effectiveness or adverse effects were evident, but not enough people aged 65 and over were studied. Dose adjustment may be necessary in elderly people with reduced kidney function.

Section

8.5 Geriatric Use

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

In clinical trials, 3% of patients were over age 60. No age-related differences in effectiveness or adverse effects were evident. However, clinical studies of topiramate did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently than younger subjects. Dosage adjustment may be necessary for elderly with age-related renal impairment (creatinine clearance rate <70 mL/min/1.73 m 2) resulting in reduced clearance [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].

Missed dose

Medlineplus

For tablets, take the missed dose as soon as you remember. If it is less than 6 hours before your next dose, skip it. Do not double up.

Section

MedlinePlus: What should I do if I forget a dose? (tablets, sprinkle capsules, solution)

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

If you are taking topiramate tablets, sprinkle capsules, or solution, take the missed dose as soon as you remember it. However, if it is less than 6 hours before you are scheduled to take your 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

Label

Overdoses have caused convulsions, drowsiness, speech disturbance, blurred vision, double vision, confusion, lethargy, poor coordination, stupor, low blood pressure, abdominal pain, agitation, dizziness and depression. Deaths have been reported. Severe metabolic acidosis has occurred. Topiramate should be discontinued and supportive care given. Hemodialysis is an effective way to remove it.

Section

10 OVERDOSAGE

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving topiramate. Topiramate overdose has resulted in severe metabolic acidosis [see Warnings and Precautions (5.4)]. A patient who ingested a dose of topiramate between 96 and 110 g was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. In the event of overdose, topiramate should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved. Hemodialysis is an effective means of removing topiramate from the body.

Medlineplus

For overdose call poison control at 1-800-222-1222. Call 911 if the person has collapsed, had a seizure, has trouble breathing or can't be awakened.

Section

MedlinePlus: In case of emergency/overdose

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

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

Label

Store at 20° to 25°C (68° to 77°F), with short trips to 15° to 30°C (59° to 86°F) allowed. Protect from moisture and keep in a tight container.

Section

16.2 Storage and Handling (Sun label; storage details are labeler-specific)

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Store topiramate tablets 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]. Protect from moisture. Dispense in a tight container.

Medlineplus

Keep it in the original container, tightly closed, out of reach of children. Store tablets at room temperature away from heat and moisture (not in the bathroom).

Section

MedlinePlus: storage and disposal

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

Keep this medication in the container it came in, tightly closed, and out of reach of children. Tablets, extended-release capsules, extended-release sprinkle capsules, and solution should be stored at room temperature and away from excess heat and moisture (not in the bathroom).

Boxed warning

NONE

Contraindications

Do not use if you have had a hypersensitivity reaction to topiramate or any inactive ingredient in the tablet. Anaphylaxis and angioedema have occurred.

Section

4 CONTRAINDICATIONS

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate is contraindicated in patients with a history of hypersensitivity reaction to topiramate, topiramate tablet or any of the inactive ingredients of topiramate tablet. Anaphylaxis and angioedema have occurred [see Warnings and Precautions (5.13)]

Warnings and precautions

A syndrome of sudden blurred vision and/or eye pain with raised eye pressure has been reported, usually within 1 month of starting topiramate, in children as well as adults. The main treatment is to stop topiramate as quickly as possible, as the treating doctor decides. Untreated high eye pressure can lead to permanent vision loss.

Heading

5.1 Acute Myopia and Secondary Angle Closure Glaucoma Syndrome

Section

5.1

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate, may be helpful. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

Loss of parts of the field of vision has been reported. Most cases in trials went away after topiramate was stopped. If vision problems occur, stopping the drug should be considered.

Heading

5.2 Visual Field Defects

Section

5.2

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.

Topiramate can reduce sweating and raise body temperature, mostly in children and especially in hot weather. Patients should be monitored closely.

Heading

5.3 Oligohidrosis and Hyperthermia

Section

5.3

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures. The majority of the reports have been in pediatric patients. Patients (especially pediatric patients) treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when topiramate is given with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

Topiramate can make the blood too acidic (low bicarbonate) because of how it works on the kidneys. It can happen at any time. The average drop in bicarbonate was 4 mEq/L at 400 mg/day in adults. Signs can include fast breathing, tiredness and loss of appetite, and untreated acidosis can lead to kidney stones and bone problems. Baseline and periodic blood bicarbonate checks are recommended. If it persists, the dose may be reduced or the drug stopped.

Heading

5.4 Metabolic Acidosis

Section

5.4

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by topiramate. Topiramate-induced metabolic acidosis can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet, or specific drugs) may be additive to the bicarbonate lowering effects of topiramate. Metabolic acidosis was commonly observed in adult and pediatric patients treated with topiramate in clinical trials. The incidence of decreased serum bicarbonate in pediatric trials, for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial-onset seizures was as high as 67% for topiramate (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value < 17 mEq/L and >5 mEq/L decrease from pretreatment) in these trials was up to 11%, compared to < 2% for placebo. Manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures [see Warnings and Precautions (5.9, 5.15)]. Measurement of Serum Bicarbonate in Epilepsy and Migraine Patients: Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face of persistent acidosis, alkali treatment should be considered. (Middle paragraphs on bone density, growth and pregnancy omitted from this excerpt; see label.)

Antiepileptic drugs, including topiramate, raise the risk of suicidal thoughts or behavior. Patients should be watched for new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior. In pooled trials the rate was 0.43% with AEDs vs 0.24% with placebo.

Heading

5.5 Suicidal Behavior and Ideation

Section

5.5

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Antiepileptic drugs (AEDs), including topiramate, 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. 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. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. (Remaining paragraphs and Table 4 omitted from this excerpt; see label.)

Topiramate can cause confusion, slowed thinking, trouble concentrating or remembering, speech or word-finding problems, depression or mood problems, and sleepiness or tiredness.

Heading

5.6 Cognitive/Neuropsychiatric Adverse Reactions

Section

5.6

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate can cause cognitive/neuropsychiatric adverse reactions. The most frequent of these can be classified into three general categories: 1) Cognitive-related dysfunction (e.g., confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech or language problems, particularly word-finding difficulties); 2) Psychiatric/behavioral disturbances (e.g., depression or mood problems); and 3) Somnolence or fatigue. (Adult and pediatric trial details omitted from this excerpt; see label.)

Topiramate can harm an unborn baby. Pregnancy registry data show a higher risk of birth defects, including cleft lip and/or cleft palate, and of babies being small for gestational age. It should be used in pregnancy only if the potential benefit outweighs the potential risk.

Heading

5.7 Fetal Toxicity

Section

5.7

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring [see Use in Specific Populations (8.1)]. Consider the benefits and the risks of topiramate when administering this drug in women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death [see Use in Specific Populations (8.1), Patient Counseling Information (17)]. Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].

Topiramate should be stopped gradually to lower the chance of seizures.

Heading

5.8 Withdrawal of Antiepileptic Drugs

Section

5.8

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including topiramate, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency [see Clinical Studies (14)]. In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended.

In a one-year study of children, topiramate lowered bone mineral density; 21% of topiramate-treated patients had clinically important reductions compared to 0 in the control group. It was not known whether fracture risk is increased.

Heading

5.9 Decrease in Bone Mineral Density

Section

5.9

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Results of a one-year active-controlled study in pediatric patients (N=63) demonstrated negative effects of topiramate monotherapy on bone mineral acquisition via statistically significant decreases in bone mineral density (BMD) measured in lumbar spine and in total body less head [see Use in Specific Populations (8.4)]. Twenty-one percent of topiramate treated patients experienced clinically important reductions in BMD (Z score change from baseline of –0.5 or greater) compared to 0 patients in the control group. Although decreases in BMD occurred across all pediatric age subgroups, patients 6 to 9 years of age were most commonly affected. The sample size and study duration were too small to determine if fracture risk is increased. Decreased BMD in the lumbar spine was correlated with decreased serum bicarbonate, which commonly occurs with topiramate treatment and reflects metabolic acidosis, a known cause of increased bone resorption [see Warnings and Precautions (5.4)].

Topiramate may slow weight gain and height increase in children. Growth of children on long-term therapy should be carefully monitored.

Heading

5.10 Negative Effects on Growth (Height and Weight)

Section

5.10

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Results of a one-year active-controlled study of pediatric patients (N=63) demonstrated negative effects of topiramate monotherapy on growth (i.e., height and weight) [see Use in Specific Populations (8.4)]. Although continued growth was observed in both treatment groups, the topiramate group showed statistically significant reductions in mean annual change from baseline in body weight compared to the control group. A similar trend of attenuation in height velocity and height change from baseline was also observed in the topiramate group compared to the control group. Negative effects on weight and height were seen across all topiramate age subgroups. Growth (height and weight) of children receiving prolonged topiramate therapy should be carefully monitored.

DRESS, a serious reaction that can be fatal or life-threatening, has been reported. It can show up as fever, rash, swollen lymph nodes and/or facial swelling with other organ involvement. Topiramate should be stopped if no other cause can be found.

Heading

5.11 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions

Section

5.11

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking topiramate. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Topiramate should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Serious skin reactions (SJS and TEN) have been reported. Topiramate should be stopped at the first sign of a rash unless the rash is clearly not drug-related.

Heading

5.12 Serious Skin Reactions

Section

5.12

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. Topiramate should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Inform patients about the signs of serious skin reactions.

Serious allergic reactions, including anaphylaxis and angioedema, have occurred. If one occurs, topiramate should be stopped.

Heading

5.13 Anaphylaxis and Angioedema

Section

5.13

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with topiramate in the postmarketing setting. If a hypersensitivity reaction occurs, discontinue topiramate and initiate appropriate therapy [see Contraindications (4)].

Topiramate can raise blood ammonia, with or without confusion or brain effects (encephalopathy), more often when taken with valproic acid. Unexplained lethargy, vomiting or changes in mental status should prompt an ammonia level.

Heading

5.14 Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use)

Section

5.14

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate treatment can cause hyperammonemia with or without encephalopathy [see Adverse Reactions (6.2)]. The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone [see Drug Interactions (7.1)]. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. In most cases, hyperammonemic encephalopathy abated with discontinuation of treatment. In patients who develop unexplained lethargy, vomiting or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.

Topiramate raises the risk of kidney stones (1.5% in adults in adjunctive epilepsy trials). Using it with other drugs that cause acidosis, or on a ketogenic diet, should be avoided. Drinking more fluids is recommended.

Heading

5.15 Kidney Stones

Section

5.15

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate increases the risk of kidney stones. During adjunctive epilepsy trials, the risk for kidney stones in topiramate-treated adults was 1.5%, an incidence about 2 to 4 times greater than expected in a similar, untreated population. As in the general population, the incidence of stone formation among topiramate-treated patients was higher in men. Kidney stones have also been reported in pediatric patients taking topiramate for epilepsy or migraine. Topiramate is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH [see Warnings and Precautions (5.4)]. The concomitant use of topiramate with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Hydration is recommended to reduce new stone formation.

Low body temperature (below 35°C or 95°F) has been reported when topiramate is used with valproic acid. Stopping topiramate or valproate should be considered if it occurs.

Heading

5.16 Hypothermia with Concomitant Valproic Acid Use

Section

5.16

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Hypothermia, defined as a drop in body core temperature to <35°C (95°F), has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia. This adverse reaction in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate [see Drug Interactions (7.1)]. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems. Clinical management and assessment should include examination of blood ammonia levels.

Pregnancy and breastfeeding

Label

Topiramate can cause fetal harm, with an increased risk of birth defects such as cleft lip and/or cleft palate and of babies being small for gestational age. Women who might become pregnant should be told of the risk and should use effective contraception if not planning a pregnancy. Topiramate is excreted in human milk, and diarrhea and somnolence have been reported in breastfed infants.

Section

8.1 Pregnancy; 8.2 Lactation; 8.3 Females and Males of Reproductive Potential

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

8.1 Pregnancy, Risk Summary: Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in uterohave an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA) [see Human Data]. SGA has been observed at all doses and appears to be dose-dependent. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy. In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped topiramate use before the third trimester. || 8.1 Clinical Considerations: Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. || 8.2 Lactation, Risk Summary: Topiramate is excreted in human milk [see Data].The effects of topiramate on milk production are unknown. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for topiramate and any potential adverse effects on the breastfed infant from topiramate or from the underlying maternal condition. || 8.3 Contraception: Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risk of major congenital malformations, including oral clefts, and the risk of infants being SGA [see Drug Interactions (7.4) and Use in Specific Populations 8.1].

Medlineplus

Tell your doctor if you are pregnant, plan to be, or are breast-feeding. If you become pregnant, call your doctor right away but do not stop topiramate before talking to your doctor.

Section

MedlinePlus: special precautions

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.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 you are taking topiramate, call your doctor right away, but do not stop taking topiramate before talking to your doctor. Topiramate may harm the fetus.

Side effects

Common

For epilepsy, the most common side effects (at least 10% more frequent than placebo or low-dose topiramate) were paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever. For migraine (at least 5% more frequent than placebo) they were paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.

Section

Highlights: Adverse Reactions

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Threshold

Epilepsy: ≥10% more frequent than placebo or low-dose topiramate; Migraine: ≥5% more frequent than placebo

Source text (exact source wording)

Epilepsy: Most common (≥10% more frequent than placebo or low-dose topiramate) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever (6.1) || Migraine: Most common (≥5% more frequent than placebo) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection (6.1)

Common medlineplus

MedlinePlus lists side effects to report if severe or not going away: numbness, burning or tingling in the hands or feet, slowed reactions, nervousness, weakness, lack of appetite and weight loss, change in taste, diarrhea, and menstrual bleeding changes.

Section

MedlinePlus: side effects

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

Topiramate may cause other side effects. Tell your doctor if any of these symptoms are severe or do not go away: numbness, burning, or tingling in the hands or feet slowed reactions nervousness weakness lack of appetite, weight loss change in ability to taste food diarrhea menstrual bleeding changes

Less common

In adult migraine trials, reactions in at least 3% of patients and above placebo included fatigue, dizziness, language problems, abdominal pain, dyspepsia, dry mouth, gastroenteritis, arthralgia, somnolence, insomnia, difficulty with concentration/attention, mood problems, anxiety, depression, nervousness and confusion, with percentages in the table above (for example fatigue 15% at 100 mg/day vs 11% for placebo).

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Table 8: Adverse Reactions in Pooled, Placebo-Controlled, Migraine Trials in Adults (percent of patients; Placebo N=445 / Topiramate 50 mg/day N=235 / Topiramate 100 mg/day N=386). Fatigue 11 / 14 / 15; Injury 7 / 9 / 6; Paresthesia 6 / 35 / 51; Dizziness 10 / 8 / 9; Hypoesthesia 2 / 6 / 7; Language problems 2 / 7 / 6; Nausea 8 / 9 / 13; Diarrhea 4 / 9 / 11; Abdominal pain 5 / 6 / 6; Dyspepsia 3 / 4 / 5; Dry mouth 2 / 2 / 3; Gastroenteritis 1 / 3 / 3; Weight loss 1 / 6 / 9; Arthralgia 2 / 7 / 3; Anorexia 6 / 9 / 15; Somnolence 5 / 8 / 7; Difficulty with memory 2 / 7 / 7; Insomnia 5 / 6 / 7; Difficulty with concentration/attention 2 / 3 / 6; Mood problems 2 / 3 / 6; Anxiety 3 / 4 / 5; Depression 4 / 3 / 4; Nervousness 2 / 4 / 4; Confusion 2 / 2 / 3. (Table 8 as printed in the label text read; the label text read ends the table at Confusion. Table 5 monotherapy, Table 6 adjunctive adult, Table 7 adjunctive pediatric and later migraine tables were not captured in this record.)

Serious

Label postmarketing

After approval, reports included serious allergic reactions, delayed hypersensitivity, reduced sweating and high body temperature, high ammonia, low body temperature with valproic acid, liver failure including deaths, hepatitis, pancreatitis, serious blistering skin reactions, kidney stones, nephrocalcinosis, acute myopia, secondary angle closure glaucoma, maculopathy, and a decrease in INR with warfarin-type medicines.

Section

6.2 Postmarketing Experience

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

6.2 Postmarketing Experience: The following adverse reactions have been identified during post approval use of topiramate. 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. Body as a Whole-General Disorders: immediate hypersensitivity reactions (including anaphylaxis and angioedema) [see Warnings and Precautions (5.13)], delayed hypersensitivity reactions (including facial swelling, lip swelling, periorbital swelling, tongue swelling), oligohydrosis and hyperthermia [see Warnings and Precautions (5.3)], hyperammonemia, hyperammonemic encephalopathy [see Warnings and Precautions (5.14)], hypothermia with concomitant valproic acid [see Warnings and Precautions (5.16)] Gastrointestinal System Disorders:hepatic failure (including fatalities), hepatitis, pancreatitis Skin and Appendage Disorders:bullous skin reactions (including erythema multiforme, Stevens- Johnson syndrome, toxic epidermal necrolysis) [see Warnings and Precautions (5.12)], pemphigus, urticaria Urinary System Disorders:kidney stones, nephrocalcinosis [see Warnings and Precautions (5.4, 5.15)] Vision Disorders:acute myopia, secondary angle closure glaucoma [see Warnings and Precautions (5.1)], maculopathy Hematological Disorders:decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin.

Label warnings

See warnings_and_precautions 5.1 to 5.16 (angle closure glaucoma, visual field defects, decreased sweating, metabolic acidosis, suicidal thoughts, cognitive and mood effects, fetal toxicity, DRESS, serious skin reactions, anaphylaxis, hyperammonemia, kidney stones, hypothermia with valproic acid).

Medlineplus

MedlinePlus lists symptoms that need a call to the doctor right away, including rash, hives, blisters, peeling skin, fever, trouble breathing or swallowing, swelling, vision changes, eye pain, worsening seizures, feeling cold or low body temperature, confusion, memory or speech problems, extreme tiredness, coma, loss of coordination, chest pain, irregular heartbeat, intense back or side pain, and signs of infection.

Section

MedlinePlus: side effects

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

Some side effects can be serious. If you experience any of the following symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately: rash, hives, skin blisters, skin peeling, fever, trouble breathing or swallowing, or swelling of your face, eyes, lips, tongue, or throat blurred, double, or loss of vision eye redness, or pain worsening of seizures feeling cold, chills, or low body temperature nausea, vomiting, difficulty concentrating, confusion, memory problems, or speech problems excessive tiredness, confusion, coma (loss of consciousness for a period of time) loss of coordination chest pain, pounding or irregular heartbeat intense back or side pain fever or other signs of infection

Led to discontinuation

Section

6.1 Clinical Trials Experience

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Monotherapy Epilepsy, Adults 16 Years of Age and Older: Approximately 21% of the 159 adult patients in the 400 mg/day group who received topiramate as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common (≥ 2% more frequent than low-dose 50 mg/day topiramate) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia. || Pediatric Patients 6 to 15 Years of Age: Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. The most common (≥2% more frequent than low-dose 50 mg/day topiramate) adverse reactions resulting in discontinuation were difficulty with concentration/attention, fever, flushing, and confusion. || Adjunctive Therapy Epilepsy, Adults: In controlled clinical trials in adults, 11% of patients receiving topiramate 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. This rate appeared to increase at dosages above 400 mg/day. Adverse reactions associated with discontinuing topiramate included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue and paresthesia. || Adjunctive Therapy Epilepsy, Pediatric Patients 2 to 15 Years of Age: None of the pediatric patients who received topiramate adjunctive therapy at 5 to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions. (Migraine discontinuation rates were not captured.)

Interactions

Drugs

Phenytoin or carbamazepine can lower topiramate levels, and a dose adjustment may be needed. Valproic acid with topiramate has been linked to low body temperature and high blood ammonia, with or without brain effects.

Name

Phenytoin, carbamazepine, valproic acid (antiepileptic drugs)

Section

7.1

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. A dosage adjustment may be needed [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)]. Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions (5.14, 5.16), Clinical Pharmacology (12.3)].

Using topiramate with another carbonic anhydrase inhibitor such as zonisamide or acetazolamide may worsen acidosis and raise the risk of kidney stones, so patients are monitored closely.

Name

Other carbonic anhydrase inhibitors (zonisamide, acetazolamide)

Section

7.2

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Therefore, patients given topiramate concomitantly with another carbonic anhydrase inhibitor should be monitored particularly closely for the appearance or worsening of metabolic acidosis [see Clinical Pharmacology (12.3)].

Topiramate can cause sleepiness and thinking problems, so extreme caution is advised with alcohol and other medicines that slow the brain. This combination was not studied in clinical studies.

Name

CNS depressants

Section

7.3

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Concomitant administration of topiramate and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, topiramate should be used with extreme caution if used in combination with alcohol and other CNS depressants.

Topiramate may make birth control less effective, even without breakthrough bleeding. Report any change in bleeding patterns.

Name

Hormonal contraceptives

Section

7.4

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking contraceptive products with topiramate. Patients taking estrogen-containing or progestin-only contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding [see Clinical Pharmacology (12.3)].

Adding HCTZ raised topiramate levels. The topiramate dose may need to be decreased.

Name

Hydrochlorothiazide (HCTZ)

Section

7.5

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate Cmax and AUC increased when HCTZ was added to topiramate. The clinical significance of this change is unknown. The addition of HCTZ to topiramate may require a decrease in the topiramate dose [see Clinical Pharmacology (12.3)].

Topiramate lowered pioglitazone exposure. Patients should be monitored for control of their diabetes.

Name

Pioglitazone

Section

7.6

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and topiramatein a clinical trial. The clinical relevance of these observations is unknown; however, when topiramate is added to pioglitazone therapy or pioglitazone is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state [see Clinical Pharmacology (12.3)].

Lithium levels can rise with topiramate and should be monitored with high doses.

Name

Lithium

Section

7.7

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

An increase in systemic exposure of lithium following topiramate doses of up to 600 mg/day can occur. Lithium levels should be monitored when coadministered with high-dose topiramate [see Clinical Pharmacology (12.3)].

Amitriptyline levels may rise a lot with topiramate. Dose changes should be based on how the patient responds.

Name

Amitriptyline

Section

7.8

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see Clinical Pharmacology (12.3)].

Topiramate raised metformin levels (Cmax by 18% and AUC by 25%). The clinical significance is not known.

Name

Metformin

Section

12.3 Drug Interactions

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

The results of this study indicated that the mean metformin C maxand AUC 0-12hincreased by 18% and 25%, respectively, when topiramate was added. Topiramate did not affect metformin t max. The clinical significance of the effect of topiramate on metformin pharmacokinetics is not known. Oral plasma clearance of topiramate appears to be reduced when administered with metformin. The clinical significance of the effect of metformin on topiramate pharmacokinetics is unclear.

Topiramate lowered glyburide exposure (AUC24 by 25%).

Name

Glyburide

Section

12.3 Drug Interactions

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

There was a 22% decrease in Cmax and a 25% reduction in AUC24 for glyburide during topiramate administration. Systemic exposure (AUC) of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), was also reduced by 13% and 15%, and Cmax was reduced by 18% and 25%, respectively. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide.

A drop in INR or prothrombin time has been reported when topiramate is given with warfarin-type medicines.

Name

Warfarin (vitamin K antagonists)

Section

6.2 Postmarketing Experience

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Hematological Disorders:decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin.

Food and alcohol

The label says tablets can be taken with or without meals.

Name

Meals (label)

Section

2.4 Administration Information

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Topiramate tablets can be taken without regard to meals.

The label advises extreme caution with alcohol.

Name

Alcohol (label)

Section

7.3

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Combining topiramate with a ketogenic diet may raise the risk of kidney stones and should be avoided.

Name

Ketogenic diet (label)

Section

5.15

Source

DailyMed Sun Pharmaceutical Industries topiramate tablets label (set ID 3c909a53-ae66-4b28-a741-b60bb25a69cf), Revised: 4/2026

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

The concomitant use of topiramate with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.

MedlinePlus says to tell your doctor if you drink alcohol, that your doctor may say not to drink alcohol with other topiramate products, and not to follow a ketogenic or other high-fat, low-carbohydrate diet.

Name

Alcohol and ketogenic diet (MedlinePlus)

Section

MedlinePlus: special precautions; special dietary instructions

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

tell your doctor if you if you drink alcohol. Do not drink alcohol within 6 hours before and 6 hours after you take extended-release capsules. Your doctor may also tell you not to drink alcohol while taking other topiramate products. Do not follow a ketogenic diet (a high-fat, low-carbohydrate diet used to control seizures) or any other high-fat, low-carbohydrate diet while you are taking this medication.

Other

MedlinePlus lists aspirin and NSAIDs such as ibuprofen and naproxen as products that may interact. The label sections read do not list them.

Name

Aspirin and NSAIDs (MedlinePlus)

Section

MedlinePlus: special precautions

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

you should know that the following nonprescription or herbal products may interact with topiramate: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen and naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking topiramate. Do not start any of these medications while taking topiramate without talking to your healthcare provider.

Patient tips

Label section 17

The label tells prescribers to counsel patients to get medical help right away for blurred vision, visual problems or eye pain; to watch for reduced sweating and fever, especially in hot weather; to know the risks of metabolic acidosis; to watch for depression, unusual mood or behavior changes or suicidal thoughts and report them right away; and not to drive or operate machinery until they know how topiramate affects them.

Source url

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3c909a53-ae66-4b28-a741-b60bb25a69cf&type=display

Source text (exact source wording)

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Eye Disorders: Instruct patients taking topiramate tablets to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions (5.1, 5.2)]. Oligohidrosis and Hyperthermia: Closely monitor topiramate-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Warnings and Precautions (5.3)]. Metabolic Acidosis: Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)]. Suicidal Behavior and Ideation: Counsel patients, their caregivers, and families that AEDs, including topiramate tablets, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. Instruct patients to immediately report behaviors of concern to their healthcare providers [see Warnings and Precautions (5.5)]. Interference with Cognitive and Motor Performance: Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on topiramate tablets to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions (5.6)].

Medlineplus how to take

Take it once or twice a day at around the same times, with or without food. Swallow tablets whole because of the bitter taste, and do not use tablets that have been broken for any length of time. Keep taking it even if you feel well. Do not stop without talking to your doctor, because suddenly stopping may cause severe seizures.

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

Take the tablets, sprinkle capsules, and solution with or without food once or twice a day. Take topiramate at around the same time(s) every day. Take topiramate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Topiramate tablets have a bitter taste so you should swallow them whole. Do not take topiramate tablets that have been broken for any length of time because broken tablets may lose their effectiveness over time. Continue to take topiramate even if you feel well. Do not stop taking topiramate without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking topiramate, you may have severe seizures, even if you have not had seizures in the past. Your doctor will probably decrease your dose gradually.

Medlineplus avoid

Do not drive or use machinery until you know how topiramate affects you. Avoid heat, drink plenty of fluids and tell your doctor about fever or if you are not sweating as usual. Drink plenty of fluids to help prevent kidney stones. Do not follow a ketogenic or other high-fat, low-carbohydrate diet.

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

you should know that topiramate may make you drowsy, dizzy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you. Avoid exposure to heat, drink plenty of fluids and tell your doctor if you have a fever, headache, muscle cramps, or an upset stomach, or if you are not sweating as usual. Drink plenty of water or other fluids every day to prevent kidney stones from forming. Do not follow a ketogenic diet (a high-fat, low-carbohydrate diet used to control seizures) or any other high-fat, low-carbohydrate diet while you are taking this medication.

Medlineplus when to call

Call your doctor right away for rash, hives, blisters or peeling skin, fever, trouble breathing or swallowing, swelling of the face, eyes, lips, tongue or throat; blurred, double or lost vision; eye redness or pain; worsening seizures; feeling cold or low body temperature; confusion or memory problems; extreme tiredness or coma; loss of coordination; chest pain or irregular heartbeat; intense back or side pain; or fever or other signs of infection.

Source

MedlinePlus Topiramate (Last Revised - 05/15/2026)

Source url

https://medlineplus.gov/druginfo/meds/a697012.html

Source text (exact source wording)

Alternatives

Class source

MedlinePlus: anticonvulsants (https://medlineplus.gov/druginfo/meds/a697012.html). openFDA returned no pharmacologic class (EPC) for topiramate in two searches, so no class member list could be sourced.

Class source urls

https://medlineplus.gov/druginfo/meds/a697012.html

Note

No candidates are named because none could be sourced. No recommendation is made.

Frequently asked questions

Question

What is topiramate used for?

Answer

The label lists treating certain seizures (initial monotherapy for patients 2 years of age and older, and adjunctive therapy for patients 2 years of age and older) and preventing migraine in patients 12 years of age and older. MedlinePlus notes it is used to prevent migraines, not to relieve the pain once a migraine starts.

Source section

1 INDICATIONS AND USAGE; MedlinePlus

Source

DailyMed Sun label; MedlinePlus

Question

Can I take topiramate with food?

Answer

Yes. The label says the tablets can be taken without regard to meals, and the tablets should not be broken because of the bitter taste.

Source section

2.4 Administration Information

Source

DailyMed Sun label

Question

What should I do if I miss a dose?

Answer

The label text read gives no missed-dose instructions. MedlinePlus says for tablets, sprinkle capsules or solution, to take the missed dose as soon as you remember, but if it is less than 6 hours before your next dose, to skip the missed dose, and not to take a double dose.

Source section

MedlinePlus: forget a dose

Source

MedlinePlus

Question

Can I drink alcohol with topiramate?

Answer

The label says to use extreme caution if topiramate is used with alcohol and other CNS depressants. MedlinePlus says to tell your doctor if you drink alcohol, and that your doctor may tell you not to drink alcohol while taking other topiramate products.

Source section

7.3; MedlinePlus: special precautions

Source

DailyMed Sun label; MedlinePlus

Question

What are the most common side effects?

Answer

For epilepsy, the label lists these as most common (at least 10% more frequent than placebo or low-dose topiramate): paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever. For migraine (at least 5% more frequent than placebo): paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.

Source section

Highlights: Adverse Reactions; 6.1

Source

DailyMed Sun label

Question

Is topiramate safe in pregnancy or while breastfeeding?

Answer

The label says topiramate can cause fetal harm, with an increased risk of birth defects including cleft lip and/or cleft palate and of babies being small for gestational age. It should be used during pregnancy only if the potential benefit outweighs the potential risk. It is excreted in human milk, and diarrhea and somnolence have been reported in breastfed infants. MedlinePlus says to call your doctor right away if you become pregnant, but not to stop taking topiramate before talking to your doctor.

Source section

5.7; 8.1; 8.2; MedlinePlus

Source

DailyMed Sun label; MedlinePlus

Question

Does topiramate affect birth control?

Answer

The label says there may be decreased contraceptive efficacy and increased breakthrough bleeding, and that efficacy can be decreased even without breakthrough bleeding. Patients should report any change in bleeding patterns, and women of childbearing potential who are not planning a pregnancy should use effective contraception.

Source section

7.4; 8.3

Source

DailyMed Sun label

Question

Should I stop topiramate when I feel well?

Answer

No. MedlinePlus says to continue taking it even if you feel well and not to stop without talking to your doctor, because suddenly stopping may cause severe seizures. The label says antiepileptic drugs, including topiramate, should be gradually withdrawn.

Source section

MedlinePlus: how should this medicine be used; 5.8

Source

DailyMed Sun label; MedlinePlus

Sources

DailyMed topiramate tablets, Sun Pharmaceutical Industries, Inc. (chosen primary)
Set id: 3c909a53-ae66-4b28-a741-b60bb25a69cf · Label effective or revised date: Revised: 4/2026 · Dailymed version date: list publish Jun 03, 2026 · Fetched at: 2026-11-03 · Sections used: Highlights; 1-4; 5.1-5.16; 6.1 (tables 5-8 partly); 6.2; 7; 8; 10; 11; 12.1-12.3; 16.2; 17 (partial)
Alternate 1: Zydus Pharmaceuticals USA Inc. topiramate tablets
Set id: 67dcdd6e-48bc-418e-a887-805929d83ce0 · Label effective or revised date: Revised: 4/2026 · Dailymed version date: list publish Apr 27, 2026 · Fetched at: 2026-11-03 · Sections used: Revised line only
Alternate 2: Glenmark Pharmaceuticals Inc., USA topiramate tablets
Set id: 35312f49-decf-428d-bf5f-4215b762ed3c · Label effective or revised date: Revised: 4/2026 · Dailymed version date: list publish Apr 16, 2026 · Fetched at: 2026-11-03 · Sections used: Revised line only
DailyMed Topamax (Janssen), brand label
Set id: 21628112-0c47-11df-95b3-498d55d89593 · Label effective or revised date: Revised: 3/2026 · Dailymed version date: list publish Oct 06, 2026 · Fetched at: 2026-11-03 · Sections used: Highlights excerpts only
MedlinePlus Topiramate
Set id: n/a · Label effective or revised date: Last Revised - 05/15/2026 · Fetched at: 2026-11-03 · Sections used: all patient sections
openFDA drug label API (pharmacologic class)
Set id: n/a · Label effective or revised date: n/a (returned NOT_FOUND 'Nothing to count') · Fetched at: 2026-11-03 · Sections used: none
Drugs@FDA
Label effective or revised date: NOT FOUND (not searched) · 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