Axcel Azithromycin Side Effects

Lists of the adverse reactions identified by system organ class and frequency. The frequency grouping is defined using the following convention: Very common; common; uncommon; rare; very rare; not known. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
lnfections and infestations: Uncommon: Candidiasis, Vaginal infection, Pneumonia, Fungal infection, Bacterial infection, Pharyngitis, Gastroenteritis, Respiratory disorder, Rhinitis, Oral candidiasis; Not known: Pseudomembranous colitis.
Blood and lymphatic system disorders: Uncommon: Leukopenia, Neutropenia, Eosinophilia; Not known: Thrombocytopenia, Haemolytic anaemia.
lmmune system disorders: Uncommon: Angioedema, Hypersensitivity; Not known: Anaphylactic reaction.
Metabolism and nutrition disorders: Uncommon: Anorexia.
Psychiatric disorders: Uncommon: Nervousness, lnsomnia; Rare: Agitation, Depersonalisation; Not known: Aggression, Anxiety, Delirium, Hallucination.
Nervous system disorders: Common: Headache; Uncommon: Dizziness, Somnolence, Dysgeusia, Paraesthesia; Not known: Syncope, Convulsion, Hypoaesthesia, Psychomotor hyperactivity, Anosmia, Ageusia, Parosmia, Myasthenia gravis.
Eye disorders: Uncommon: Visual impairment; Not known: Blurred vision.
Ear and labyrinth disorders: Uncommon: Ear disorder, Vertigo; Not known: Hearing impairment including deafness and/or tinnitus.
Cardiac disorders: Uncommon: Palpitations; Not known: Torsades de pointes, Arrhythmia including ventricular tachycardia electrocardiogram QT prolonged.
Vascular disorders: Uncommon: Hot flush; Not known: Hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea, Epistaxis.
Gastrointestinal disorders: Very common: Diarrhoea; Common: Vomiting, Abdominal pain, Nausea; Uncommon: Constipation, Flatulence, Dyspepsia, Gastritis, Dysphagia, Abdominal distension, Dry mouth, Eructation, Mouth ulceration, Salivary hypersecretion; Not known: Pancreatitis, Tongue discolouration.
Hepatobiliary disorders: Uncommon: Hepatitis; Rare: Hepatic function abnormal, Jaundice cholestatic. Not known: Hepatic failure (which has rarely resulted in death), Hepatitis fulminant, Hepatic necrosis.
Skin and subcutaneous tissue Disorders: Uncommon: Rash, Pruritus, Urticaria, Dermatitis, Dry skin, Hyperhidrosis; Rare: Photosensitivity reaction, Acute generalised exanthematous pustulosis (AGEP). Not known: Erythema multiforme, 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).
Musculoskeletal and connective tissue disorders: Uncommon: Osteoarthritis, Myalgia, Back pain, Neck pain; Not known: Arthralgia.
Renal and urinary disorders: Uncommon: Dysuria, Renal pain; Not known: Renal failure acute, Nephritis interstitial.
Reproductive system and breast disorders: Uncommon: Metrorrhagia, Testicular disorder.
General disorders and administration site conditions: Uncommon: Oedema, Asthenia, Malaise, Fatigue, Face oedema, Chest pain, Pyrexia, Pain, Peripheral oedema.
lnvestigations: Common: Lymphocyte count decreased, Eosinophil count increased, Blood bicarbonate decreased, Basophils increased, Monocytes increased, Neutrophils increased; Uncommon: Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood bilirubin increased, Blood urea increased, Blood creatinine increased, Blood potassium abnormal, Blood alkaline phosphatase increased, Chloride increased, Glucose increased, Platelets increased, Hematocrit decreased, Bicarbonate increased, Abnormal sodium.
Injury and poisoning: Uncommon: Post procedural complication.
Adverse reactions possibly or probably related to Mycobacterium avium Complex prophylaxis and treatment. These adverse reactions differ from those reported with immediate release or the prolonged release formulations, either in kind or in frequency: Metabolism and nutrition disorders: Common: Anorexia.
Nervous system disorders: Common: Dizziness, Headache, Paraesthesia, Dysgeusia; Uncommon: Hypoaesthesia.
Eye disorders: Common: Visual impairment.
Ear and labyrinth disorders: Common: Deafness; Uncommon: Hearing impaired, Tinnitus.
Cardiac disorders: Uncommon: Palpitations.
Gastrointestinal disorders: Very common: Diarrhoea, Abdominal pain, Nausea, Flatulence, Abdominal discomfort, Loose stools.
Hepatobiliary disorders: Uncommon: Hepatitis.
Skin and subcutaneous tissue disorders: Common: Rash, Pruritus; Uncommon: Steven-Johnson syndrome, Photosensitivity reaction.
Musculoskeletal and connective tissue disorders: Common: Arthralgia.
General disorders and administration conditions: Common: Fatigue; Uncommon: Asthenia, Malaise.
Postmarketing Experience: Cardiac Disorders: Palpitations and arrhythmias including ventricular tachycardia have been reported. There have been rare reports of QT prolongation and torsades de pointes.
Gastrointestinal Disorders: Infantile hypertrophic pyloric stenosis.