Binozyt Adverse Reactions

The adverse reactions as follows identified through clinical trial experience and post-marketing surveillance by system organ class and frequency are listed.
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 grouping, undesirable effects are presented in order of decreasing seriousness.
Approximately 13% of patients in clinical trials reported adverse events, wherein gastrointestinal disorders were the most common.
Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post-marketing surveillance: Infections and infestations: Uncommon: Candidiasis, vaginal infection, pneumonia, fungal infections, bacterial infection, pharyngitis, gastroenteritis, respiratory disorder, rhinitis, oral candidiasis.
Not known: Pseudomembranous colitis (see Precautions).
Blood and lymphatic system disorders: Uncommon: Leukopenia, neutropenia, eosinophilia.
Not known: Thrombocytopenia, haemolytic anaemia.
Immune system disorders: Uncommon: Angioedema, hypersensitivity reaction.
Not known: Severe (partly fatal) anaphylactic reaction e.g. anaphylactic shock (see Precautions).
Metabolism and nutrition disorders: Uncommon: Anorexia.
Psychiatric disorders: Uncommon: Nervousness, insomnia.
Rare: Agitation.
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 (see Precautions).
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 (see Precautions), arrhythmia (see Precautions) including ventricular tachycardia, electrocardiogram QT prolonged (see Precautions).
Vascular disorders: Uncommon: Hot flush.
Not known: Hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea, epistaxis.
Gastrointestinal disorders: Very common: Diarrhea.
Common: Vomiting, abdominal pain, nausea.
Uncommon: Constipation, flatulence, dyspepsia, gastritis, dysphagia, abdominal distension, dry mouth, eructation, mouth ulceration, salivary hypersecretion.
Not known: Pancreatitis, tongue discoloration.
Hepatobiliary disorders: Rare: Hepatic function abnormal, jaundice cholestatic.
Not known: Hepatic failure (which has rarely resulted in death) (see Precautions), hepatitis fulminant, hepatic necrosis.
Skin and subcutaneous disorders: Uncommon: Rash, pruritus, urticaria, dermatitis, dry skin, hyperhidrosis.
Rare: Photosensitivity reaction, acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)*.
Not known: Stevens-Johnson syndrome, Toxic epidermal necrolysis, erythema multiforme.
* Frequency estimated with the "rule of three".
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.
Investigations: 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 based on clinical trial experience and post-marketing surveillance. 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.
Rare: Hypoaesthesia.
Eye disorders: Common: Visual impairment.
Ear and labyrinth disorders: Common: Deafness.
Rare: Hearing impaired, tinnitus.
Cardiac disorders: Rare: Palpitations.
Gastrointestinal disorders: Very common: Diarrhea, abdominal pain, nausea, flatulence, abdominal discomfort, loose stools.
Hepatobiliary disorders: Rare: Hepatitis.
Skin and subcutaneous tissue disorders: Common: Rash, pruritus.
Rare: Stevens-Johnson syndrome, photosensitivity reaction.
Musculoskeletal and connective tissue disorders: Common: Arthralgia.
General disorders and administration site conditions: Common: Fatigue.
Rare: Asthenia, malaise.