|In this section undesirable effects are defined as follows:Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).Within each frequency group, undesirable effects are listed in order of decreasing seriousness.|
Cardiac disordersRare: Palpitations, arrhythmia (including ventricular tachycardia).There is a potential risk of QT lengthening and torsades in predisposed patients (see section 4.4).
Blood and lymphatic system disordersRare: Thrombocytopenia, haemolytic anaemia and transient episodes of mild neutropenia have been observed in clinical research. No causal connection with the use of azithromycin could be established for this.
Nervous system disordersUncommon: Dizziness, convulsions, headache, somnolence, changes in smell and/or taste.Rare: Paresthesia, syncope, insomnia, hyperactivity.
Ear and labyrinth disordersRare: Loss of hearing including deafness and/or tinnitus has been reported in long-term use of high doses of azithromycin during clinical research. In those cases where follow-up data were available, the majority of these undesirable effects proved to be reversible.
Gastrointestinal disordersCommon: Nausea, vomiting, diarrhoea, gastrointestinal symptoms (pain/cramps). Uncommon: Very watery faeces (as a consequence of infrequent dehydration of the system), flatulence, digestive disturbances.Rare: Constipation, discolouration of the tongue, pancreatitis. Discolouration of the teeth and pseudomembranous colitis have been reported.
Renal and urinary disordersRare: Interstitial nephritis, acute renal failure.
Skin and subcutaneous tissue disordersUncommon: Allergic reactions including skin rash and pruritis.Rare: Allergic reactions including angio-oedema, urticaria, photosensitivity. Serious skin reactions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Musculoskeletal and connective tissue disordersUncommon: Arthralgia.
Metabolism and nutrition disordersUncommon: Anorexia.
Infections and infestationsUncommon: Vaginitis.Rare: Candidiasis.
Vascular disordersRare: Hypotension.
General disorders and administration site conditionsRare: Asthenia, fatigue, malaise.
Immune system disordersRare: Anaphylaxis, including oedema (rarely fatal) (see section 4.4).
Hepatobiliary disordersRare: Abnormal liver function, including hepatitis and cholestatic jaundice have been reported, as also have rare cases of hepatic necrosis and liver failure, which in rare cases, have resulted in death.
Psychiatric disordersRare: Aggressive reactions, restlessness, anxiety, nervousness, depersonalization, in older patients delirium can occur.