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Topamax 50 mg Tablets

NAFDAC Reg. No. B4-8212 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Topamax 50 mg Tablets
NAFDAC number
B4-8212
Active ingredient
Topiramate
Strength
50 mg
Form
Tablet
Pack size
1 x 60's (in opaque plastic bottle)
Manufacturer
Not listed
Applicant (holder)
J & J Company West Africa Limited
Approved
6 Jul 2023
Status
Active View on NAFDAC ↗
Registration valid to
5 Jul 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Topamax 50 mg Tablets is on the NAFDAC register with an active registration (B4-8212). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Topamax 50 mg Tablets is used for

From the official U.S. FDA label for topiramate, the active ingredient registered with NAFDAC.

What it is used for

Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2) Preventive treatment of migraine in patients 12 years of age and older (1.3) 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. …

Possible side effects

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma [see Warnings and Precautions (5.1)] Visual Field Defects [see Warnings and Precautions (5.2)] Oligohidrosis and Hyperthermia [see Warnings and Precautions (5.3)] Metabolic Acidosis [see Warnings and Precautions (5.4)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5)] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.6)] Decrease of Bone Mineral Density [see Warnings and Precautions (5.9)] Negative Effects on Growth (Height and Weight) [see Warnings and Precautions (5.10)] Drug Reaction with Eos …

Do not use if

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)] History of hypersensitivity reaction to topiramate, topiramate tablet or any of the inactive ingredients of topiramate tablet (4, 5.13)

Warnings

Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate as soon as possible (5.1) Visual field defects: consider discontinuation of topiramate (5.2) Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3) Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of topiramate if clinically appropriate (5.4) Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5) Cognitive/neuropsychiatric adverse reactions: use caution when operating machin …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Topamax 50 mg Tablets

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Topamax 50 mg Tablets

What is in Topamax 50 mg Tablets?

Topamax 50 mg Tablets contains Topiramate (50 mg), as tablet, according to its NAFDAC registration record.

Is Topamax 50 mg Tablets registered with NAFDAC?

Yes. Topamax 50 mg Tablets is listed on the NAFDAC register under registration number B4-8212, and its registration is active as of 5 November 2026.

Has Topamax 50 mg Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Topamax 50 mg Tablets in our automatically synced alert list.

How can I check that my pack of Topamax 50 mg Tablets is genuine?

Run a free authenticity scan with the NAFDAC number B4-8212, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Topamax 50 mg Tablets used for?

Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2) Preventive tre (Summarised from the official U.S. FDA label for topiramate. Always follow your doctor or pharmacist.)

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