Azito Dry Syrup Adverse Reactions

AZITO DRY SYRUP is well tolerated with a low incidence of side effects.
The section as follow lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: 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); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance: Infections and Infestations: Uncommon (≥1/1,000 to <1/100): Candidiasis, oral candidiasis, vaginal infection.
Not known (cannot be estimated from available data): Pseudomembranous colitis (see Precautions).
Blood and Lymphatic System Disorders: Uncommon (≥ 1/1,000 to < 1/100): Leukopenia, neutropenia.
Not known (cannot be estimated from available data): Thrombocytopenia, haemolytic anaemia.
Immune System Disorders: Uncommon (≥1/1,000 to <1/100): Angioedema, hypersensitivity.
Not known (cannot be estimated from available data): Anaphylactic reaction (see Precautions).
Metabolism and Nutrition Disorders: Common (≥ 1/100 to < 1/10): Anorexia.
Psychiatric Disorders: Uncommon (≥1/1,000 to <1/100): Nervousness.
Rare (≥ 1/10,000 to < 1/1,000): Agitation.
Not known (cannot be estimated from available data): Aggression, anxiety.
Nervous System Disorders: Common (≥ 1/100 to < 1/10): Dizziness, headache, paraesthesia, dysgeusia.
Uncommon (≥1/1,000 to <1/100): Hypoaesthesia, somnolence, insomnia.
Not known (cannot be estimated from available data): Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusia, parosmia, Myasthenia gravis (see Precautions).
Eye Disorders: Common (≥ 1/100 to < 1/10): Visual impairment.
Ear and Labyrinth Disorders: Common (≥ 1/100 to < 1/10): Deafness.
Uncommon (≥1/1,000 to <1/100): Hearing impaired, tinnitus.
Rare (≥ 1/10,000 to < 1/1,000): Vertigo.
Cardiac Disorders: Uncommon (≥1/1,000 to <1/100): Palpitations.
Not known (cannot be estimated from available data): Torsades de pointes (see Precautions), arrhythmia (see Precautions) including ventricular tachycardia.
Vascular Disorders: Not known (cannot be estimated from available data): Hypotension.
Gastrointestinal Disorders: Very common (≥1/10): Diarrhoea, abdominal pain, nausea, flatulence.
Common (≥ 1/100 to < 1/10): Vomiting, dyspepsia.
Uncommon (≥ 1/1,000 to < 1/100): Gastritis, constipation.
Not known (cannot be estimated from available data): Pancreatitis, tongue discolouration.
Hepatobiliary Disorders: Uncommon (≥ 1/1,000 to < 1/100): Hepatitis.
Rare (≥ 1/10,000 to < 1/1,000): Hepatic function abnormal.
Not known (cannot be estimated from available data): Hepatic failure (see Precautions), which has rarely resulted in death, hepatitis fulminant, hepatic necrosis, jaundice cholestatic.
Skin and Subcutaneous Tissue Disorders: Common (≥ 1/100 to < 1/10): Pruritus and rash.
Uncommon (≥ 1/1,000 to < 1/100): SJS, photosensitivity reaction, urticaria.
Rare (≥1/10,000 to <1/1,000): Acute Generalized Exanthematous Pustulosis (AGEP)^*§, Drug reaction with eosinophilia and systemic symptoms (DRESS)^*§.
Not known (cannot be estimated from available data): TEN, erythema multiforme.
Musculoskeletal, Connective Tissue Disorders: Common (≥ 1/100 to < 1/10): Arthralgia.
Renal and Urinary Disorders: Not known (cannot be estimated from available data): Renal failure acute, nephritis interstitial.
General disorders and Administration Site Conditions: Common (≥ 1/100 to < 1/10): Fatigue.
Uncommon (≥ 1/1,000 to < 1/100): Chest pain, oedema, malaise, asthenia.
Investigations: Common (≥ 1/100 to < 1/10): Lymphocyte count decreased, eosinophil count increased, blood bicarbonate decreased.
Uncommon (≥ 1/1,000 to < 1/100): Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal.
Not known (cannot be estimated from available data): Electrocardiogram QT prolonged (see Precautions).
^*ADR identified post-marketing.
^§ADR frequency represented by the estimated upper limit of the 95% confidence interval calculated using the "Rule of 3".