Zenith Suspension Adverse Reactions

In this section undesirable effects are defined as follows: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000), including isolated reports.
Approximately 13% of the patients in clinical trials reported undesirable effects. Undesirable gastrointestinal effects were most common, approximately 10%.
Infections and infestations: Uncommon: Vaginitis. Rare: Candidiasis.
Blood and the lymphatic system disorders: Rare: Thrombocytopenia, hemolytic anemia. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials for which a causal relationship with azithromycin treatment has not been confirmed.
Immune system disorders: Rare: Anaphylaxis, including edema (rarely fatal) (see Precautions).
Metabolism and nutrition disorders: Uncommon: Anorexia.
Psychiatric disorders: Rare: Aggressive reaction, agitation, anxiety, nervousness, depersonalization, in elderly patients delirium may occur.
Nervous system disorders: Uncommon: Dizziness/vertigo, convulsions, headache, somnolence, disturbances of smell and/or taste. Rare: Paresthesia, syncope, insomnia, hyperactivity.
Ear and labyrinth disorders: Rare: Impaired hearing. Impaired hearing including deafness and/or tinnitus has been reported after prolonged treatment at high doses in clinical trials. A majority of these cases has been reversible, of those that were possible to follow up.
Cardiac disorders: Rare: Palpitations, arrhythmia (including ventricular tachycardia). There is a potential risk of QT prolongation and torsades de pointes, particularly in patients who are susceptible to these conditions.
Gastrointestinal disorders: Common: Nausea, diarrhea, abdominal discomfort (pain/cramps), vomiting. Uncommon: Loose stools (as a result of infrequent dehydration), flatulence, dyspepsia. Rare: Constipation, pseudomembranous colitis, pancreatitis, discoloration of the teeth, tongue discoloration.
Hepatobiliary disorders: Rare: Abnormal liver function test values, hepatitis, cholestatic jaundice, rare cases of hepatic necrosis and hepatic failure which have rarely resulted in death.
Skin and subcutaneous tissue disorders: Uncommon: Rash, pruritus. Rare: Angioneurotic edema, urticaria, photosensitivity, erythema multiforme, Stevens-Johnson's syndrome, toxic epidermal necrolysis.
Musculoskeletal connective tissue and bone disorders: Uncommon: Arthralgia.
Renal and urinary disorders: Rare: Interstitial nephritis, acute renal failure.
General disorders: Rare: Asthenia, fatigue, malaise.