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La siguiente tabla enumera las reacciones adversas identificadas a través de la experiencia de ensayos clínicos y la vigilancia posterior a la comercialización por sistema de clasificación y frecuencia de órganos.
La agrupación de frecuencias se define utilizando la siguiente convención:
Muy frecuentes (≥1 / 10); Frecuentes (≥1 / 100 a <1/10); Poco frecuentes (≥1 / 1,000 a <1/100); Raras (≥1 / 10,000 a <1 / 1,000); Muy raro (<1 / 10,000) y no conocido (no puede estimarse a partir de los datos disponibles).
Dentro de cada grupo de frecuencias, se presentan efectos indeseables en orden decreciente de gravedad.
Reacciones adversas posiblemente o probablemente relacionadas con la azitromicina según la experiencia en ensayos clínicos y la vigilancia posterior a la comercialización:
|
System Organ Class |
Frequency |
Adverse reaction |
|
Infections and infestations |
Uncommon |
Candidiasis Vaginal infection Pneumonia Fungal infection Bacterial infection Pharyngitis Gastroenteritis Respiratory disorder Rhinitis Oral candidiasis |
|
Not known |
Pseudomembranous colitis (see section 4.4) |
|
|
Blood and lymphatic system disorders |
Uncommon |
Leukopenia Neutropenia Eosinophilia |
|
Not known |
Thrombocytopenia Haemolytic anaemia |
|
|
Immune system disorders |
Uncommon |
Angioedema Hypersensitivity |
|
Not known |
Anaphylactic reaction (see section 4.4) |
|
|
Metabolism and nutrition disorders |
Uncommon |
Anorexia |
|
Psychiatric disorders |
Uncommon |
Nervousness Insomnia |
|
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 (see section 4.4). |
|
|
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 section 4.4) Arrhythmia (see section 4.4) including ventricular tachycardia electrocardiogram QT prolonged (see section 4.4) |
|
|
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) (see section 4.4)* 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 |
Steven-Johnson syndrome Toxic epidermal necrolysis Erythema multiforme |
|
|
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 bilirubine 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 |
PRODUCTOS POR GRUPO : Drogas terminadas > Antibiótico y antivirus
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