Coveram Adverse Reactions

The following undesirable effects have been observed during treatment with perindopril or amlodipine given separately and ranked under the MedDRA classification by body system and under the following frequency:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Blood and Lymphatic System Disorders: Leucopenia/Neutropenia: Amlodipine: Very rare. Perindopril: Very rare.
Agranulocytosis or Pancytopenia: Perindopril: Very rare.
Thrombocytopenia: Amlodipine: Very rare. Perindopril: Very rare.
Hemolytic Anemia in Patients with a Congenital Deficiency of G6PDH: Perindopril: Very rare.
Decrease in Hemoglobin and Hematocrit: Perindopril: Very rare.
Immune System Disorders: Allergic Reaction (Urticaria): Amlodipine: Very rare. Perindopril: Uncommon.
Metabolism and Nutrition Disorders: Hyperglycemia: Amlodipine: Very rare.
Weight Gain: Amlodipine: Uncommon.
Weight Decrease: Amlodipine: Uncommon.
Psychiatric Disorders: Insomnia: Amlodipine: Uncommon.
Mood Changes: Amlodipine and Perindopril: Uncommon.
Sleep Disturbances: Perindopril: Uncommon.
Nervous System Disorders: Somnolence: Amlodipine: Common.
Dizziness: Amlodipine and Perindopril: Common.
Headache: Amlodipine and Perindopril: Common.
Tremor: Amlodipine: Uncommon.
Hypoesthesia: Amlodipine: Uncommon.
Paresthesia: Amlodipine: Uncommon. Perindopril: Common.
Hypertonia: Amlodipine: Very rare.
Peripheral Neuropathy: Amlodipine: Very rare.
Vertigo: Perindopril: Common.
Confusion: Perindopril: Very rare.
Eye Disorders: Visual Disturbances: Amlodipine: Uncommon. Perindopril: Common.
Ear and Labyrinth Disorders: Tinnitus: Amlodipine: Uncommon. Perindopril: Common.
Cardiac Disorders: Palpitations: Amlodipine: Common.
Syncope: Amlodipine: Uncommon.
Anginal Pain: Amlodipine: Rare.
Angina Pectoris: Perindopril: Very rare.
Myocardial Infarction (Possibly Secondary to Excessive Hypotension in High Risk Patients): Amlodipine and Perindopril: Very rare.
Arrhythmia (Including Bradycardia, Ventricular Tachycardia and Atrial Fibrillation): Amlodipine and Perindopril: Very rare.
Vascular Disorders: Flushing: Amlodipine: Common.
Hypotension (And Other Effects Related to Hypotension): Amlodipine: Uncommon. Perindopril: Common.
Stroke (Possibly Secondary to Excessive Hypotension in High-Risk Patients): Perindopril: Very rare.
Vasculitis: Amlodipine and Perindopril: Very rare.
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea: Amlodipine: Uncommon. Perindopril: Common.
Rhinitis: Amlodipine: Uncommon. Perindopril: Very rare.
Cough: Amlodipine: Very rare. Perindopril: Common.
Bronchospasm: Perindopril: Uncommon.
Eosinophilic Pneumonia: Perindopril: Very rare.
Gastrointestinal Disorders: Gingival Hyperplasia: Amlodipine: Very rare.
Abdominal Pain, Nausea: Amlodipine and Perindopril: Common.
Vomiting: Amlodipine: Uncommon. Perindopril: Common.
Dyspepsia: Amlodipine: Uncommon. Perindopril: Common.
Altered Bowel Habits: Amlodipine: Uncommon.
Dry Mouth: Amlodipine and Perindopril: Uncommon.
Dysgeusia: Perindopril: Common.
Taste Perversion: Amlodipine: Uncommon.
Diarrhea, Constipation: Perindopril: Common.
Pancreatitis: Amlodipine and Perindopril: Very rare.
Gastritis: Amlodipine: Very rare.
Hepatobiliary Disorders: Hepatitis, Cholestatic Jaundice: Amlodipine: Very rare.
Hepatitis Either Cytolytic or Cholestatic: Perindopril: Very rare.
Skin and Subcutaneous Tissue Disorders: Quincke's Edema: Amlodipine: Very rare.
Angioedema of Face, Extremities, Lips, Mucous Membranes, Tongue, Glottis, and/or Larynx: Perindopril: Uncommon.
Erythema Multiforme: Amlodipine and Perindopril: Very rare.
Alopecia: Amlodipine: Uncommon.
Purpura: Amlodipine: Uncommon.
Skin Discoloration: Amlodipine: Uncommon.
Increased Sweating: Amlodipine: Uncommon.
Sweating: Perindopril: Uncommon.
Pruritus: Amlodipine: Uncommon. Perindopril: Common.
Rash: Amlodipine: Uncommon. Perindopril: Common.
Stevens-Johnson Syndrome: Amlodipine: Very rare.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, Myalgia: Amlodipine: Uncommon.
Muscle Cramps: Amlodipine: Uncommon. Perindopril: Common.
Back Pain: Amlodipine: Uncommon.
Renal and Urinary Disorders: Micturition Disorder, Nocturia, Increased Urinary Frequency: Amlodipine: Uncommon.
Renal Impairment: Perindopril: Uncommon.
Acute Renal Failure: Perindopril: Very rare.
Reproductive System and Breast Disorders: Impotence: Amlodipine and Perindopril: Uncommon.
Gynecomastia: Amlodipine: Uncommon.
General Disorders and Administration Site Condition: Edema, Peripheral Edema: Amlodipine: Common.
Fatigue: Amlodipine: Common.
Chest Pain: Amlodipine: Uncommon.
Asthenia: Amlodipine: Uncommon. Perindopril: Common.
Pain: Perindopril: Uncommon.
Malaise: Amlodipine: Uncommon.
Investigations: Hepatic Enzymes Elevations [ALT, AST (Mostly Consistent with Cholestasis)]: Amlodipine: Very rare.
Serum Bilirubin: Perindopril: Rare.
Increases in Blood Urea and Serum Creatinine, Hyperkalemia: Perindopril: Not known.