Fluconazole Tablets, USP

SECTION 2: Hazards identification

Product definition

This product is a modified oval, pink, odorless tablet.

Health hazards

In the workplace, exposure via inhalation and skin contact may cause irritation. Eye contact can cause mechanical iritation. In therapeutic use, the most common adverse effects have been rash, headache, dizziness, nausea, vomiting, abdominal pain, diarrhea, and/or elevated liver enzymes. Hepatic toxicity and allergic reaction, including anaphylaxis, have been reported. Recent information indicates chronic, high doses (400-800 mg/day) of Fluconazole during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability Hazards: This product requires substantial pre- heating before ignition occurs. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (including carbon, magnesium and nitrogen oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

Negligible. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.