Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for terbinafine, the active ingredient registered with NAFDAC.
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )
Common (greater than 2% of patients treated with terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Terbinafine tablets are contraindicated in patients with: • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2) ] • Chronic or active liver disease [see Warnings and Precautions (5.1) ] Chronic or active liver disease. ( 4 ) History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. ( 4 )
Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases. Prior to initiating treatment and periodically during therapy, assess liver function tests. Discontinue terbinafine tablets if liver injury develops. ( 5.1 ) Taste disturbance, including taste loss, has been reported with the use of terbinafine tablets. Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue terbinafine tablets if taste disturbance occurs. ( 5.2 ) Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. …
8.1 Pregnancy Risk Summary Available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. …
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Tabisafe Tablet_ contains Terbinafine (250 mg), as tablet, according to its NAFDAC registration record.
Yes. Tabisafe Tablet_ is listed on the NAFDAC register under registration number C4-0851, and its registration is active as of 27 October 2026.
No WHO falsified or substandard medical product alert currently matches Tabisafe Tablet_ in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number C4-0851, 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.
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifu (Summarised from the official U.S. FDA label for terbinafine. Always follow your doctor or pharmacist.)
Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.