Azithro Adverse Reactions



M & H


Full Prescribing Info
Adverse Reactions
Azithromycin is well tolerated with a low incidence of side effects.
The following undesirable effects: Gastrointestinal: Nausea, vomiting, diarrhea, loose stools, abdominal discomfort (pain/cramps), and flatulence.
Hematopoietic: Transient episodes of mild neutropenia have occasionally been observed.
Liver/Biliary: Abnormal liver function.
Special Senses: 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.
The following undesirable effects in association with DMAC prophylaxis and treatment: The most frequent adverse reactions in HIV-infected patients receiving azithromycin for prophylaxis for DMAC were diarrhea, abdominal pain, nausea, loose stools, flatulence, vomiting, dyspepsia, rash, pruritus and arthralgia.
When azithromycin 600 mg 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.
The following additional undesirable effects: Body as a Whole: Asthenia, although a causal relationship has not been established; fatigue, malaise, moniliasis, and anaphylaxis (rarely fatal).
Post-marketing experience: Cardiac Disorders: Palpitations and arrhythmias including ventricular tachycardia have been reported. There have been rare reports of QT prolongation and torsades de pointes (see Precautions).
Central & Peripheral Nervous System: Dizziness/vertigo, convulsions (as seen with other macrolides), headache, hyperactivity, paresthesia, somnolence and syncope.
Gastrointestinal Disorders: Anorexia, dyspepsia, constipation, pseudomembranous colitis, pancreatitis, rare reports of tongue discoloration, vomiting/diarrhea (rarely resulting in dehydration), infantile hypertrophic pyloric stenosis.
Genitourinary: Interstitial nephritis and acute renal failure.
Hematopoietic: Thrombocytopenia.
Liver/Biliary: Hepatitis and cholestatic jaundice.
Musculoskeletal: Arthralgia.
Psychiatric: Aggressive reaction, nervousness, agitation and anxiety.
Reproductive: Vaginitis.
Skin and Subcutaneous Tissue Disorders: Allergic reactions including pruritis, rash, photosensitivity, edema, urticaria and angioedema. Frequency not known: severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) & acute generalised exanthematous pustulosis (AGEP).
Special Senses: There have been rare reports of taste perversion.
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