Azith Adverse Reactions

Undesirable effects in association with DMAC prophylaxis and treatment: The most frequent (> 5% in any treatment group) advance reactions in HIV-infected patients receiving Azithromycin for prophylaxis for DMAC were diarrhea, abdominal pain, nausea, loose stools, flatulence, vomiting, dyspepsia, rash, pruritus, headache and arthralgia.
When 600 mg Azithromycin is given daily for the treatment of DMAC infection for prolonged periods, the most frequently reported treatment-related side effects are abdominal pain, nausea, vomiting, diarrhea, flatulence, headache, abnormal vision and hearing impairment.
Undesirable effects: Infections and Infestations: moniliasis and vaginitis.
Blood and Lymphatic System Disorders: thrombocytopenia, transient episodes of mild neutropenia have occasionally been observed.
Immune System Disorders: anaphylaxis (rarely fatal).
Metabolism and Nutrition Disorders: anorexia.
Psychiatric Disorders: aggressive reaction, nervousness, agitation and anxiety.
Nervous System Disorders: dizziness, convulsions, headache, hyperactivity, hypoesthesia, paresthesia, somnolence and syncope. There have been rare reports of taste/smell perversion and/or loss.
Ear and Labyrinth Disorders: deafness, tinnitus, hearing impaired, vertigo.
Hearing impairment (including hearing loss, deafness and/or tinnitus) has been reported in some patients receiving Azithromycin. Many of these have been associated with prolonged use of high doses in investigational studies. In those cases where follow-up information was available, the majority of these events were reversible.
Cardiac Disorders: palpitations and arrhythmias including ventricular tachycardia have been reported. There have been rare reports of QT prolongations and torsades de pointes.
Vascular Disorders: hypotension.
Gastrointestinal Disorders: vomiting/diarrhea (rarely resulting in dehydration), dyspepsia, constipation, pseudomembranous colitis, pancreatitis and rare reports of tongue discoloration, nausea, loose stools, abdominal discomfort (pain/cramps) and flatulence.
Hepatobiliary Disorders: abnormal liver function. Hepatitis and cholestatic jaundice have been reported, as well as rare case of hepatic necrosis and hepatic failure, which have resulted in death.
Skin and Subcutaneous Tissue Disorders: allergic reactions including pruritus, rash, photosensitivity, edema, urticaria and angioedema. Rarely, serious cutaneous adverse reactions including erythema multiforme, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms have been reported.
Musculoskeletal and Connective Tissue Disorders: arthralgia.
Renal and Urinary Disorders: interstitial nephritis and acute renal failure.
General Disorders and Administration Site Conditions: Local pain and inflammation at the site of infusion, asthenia, fatigue and malaise.