METRONIDAZOLE TABLETS, USP

SECTION 2: Hazards identification

GHS Classification WARNING: Metronidazole has been shown to be carcinogenic in mice and rats (see current product package insert). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section of the current product package insert.

2.1 Classification of the substance or mixture

Reproductive Toxicity: Category 2 (Limited evidence of human or animal carcinogenicity) Carcinogenicity: Category 2 (Limited evidence of human or animal carcinogenicity) Primary Routes of Administration: Oral (Ingestion)

Health hazards

In the workplace, exposure via inhalation in the finished pharmaceutical product is not expected. Skin contact may cause irritation. Eye contact with drug product can cause mechanical irritation. Accidental ingestion may be harmful. In therapeutic use, the most common adverse effects reported are nausea, headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress, and abdominal cramping, sharp, metallic taste, overgrowth of Candida. Constipation has also been reported. Rare cases of pancreatitis have been reported. May cause adverse effects on neurological, cardiovascular system, Prolonged therapeutic use may cause super-infections. Use of alcohol while taking Metronidazole can cause an accumulation of systemic acetaldehyde, which can lead to serious effects or be fatal. Animal studies indicate significant carcinogenic potential. Limited evidence of mutagenic effects, based on animal data. These effects may be possible as a result of workplace exposure. Refer to current product package insert 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, iron, magnesium, sodium, silicon, titanium and nitrogen oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

This product contains a compound that may cause long-term harm to aquatic organisms. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.