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 ofloxacin, the active ingredient registered with NAFDAC.
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
Ophthalmic use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received. Refer to WARNINGS for additional adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Sentlss at 1--855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see WARNINGS ).
NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. …
Pregnancy: Teratogenic Effects: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively. …
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Ophtapharm AG, Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Ma …
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Ofloxacin Tablet 400 mg contains Ofloxacin (400 mg), as tablet, according to its NAFDAC registration record.
Yes. Ofloxacin Tablet 400 mg is listed on the NAFDAC register under registration number C4-1374, and its registration is active as of 27 October 2026.
No WHO falsified or substandard medical product alert currently matches Ofloxacin Tablet 400 mg in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number C4-1374, 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.
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: (Summarised from the official U.S. FDA label for ofloxacin. 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.