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The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in controlled clinical trials. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients.
The adverse drug reactions listed as follows have been accumulated from controlled clinical trials including 5788 hypertensive patients treated with telmisartan: Infections and Infestations: Urinary tract infections (including cystitis), upper respiratory tract infections, sepsis including fatal outcome.
Blood and Lymphatic System Disorders: Anaemia, eosinophilia, thrombocytopenia.
Immune System Disorders: Anaphylactic reaction, hypersensitivity.
Metabolism and Nutrition Disorders: Hyperkalaemia, hypoglycaemia (in diabetic patients).
Psychiatric Disorders: Insomnia, depression, anxiety.
Nervous System Disorders: Syncope (faint).
Eye Disorders: Visual disturbance.
Ear and Labyrinth Disorders: Vertigo.
Cardiac Disorders: Bradycardia, tachycardia.
Vascular Disorders: Hypotension, orthostatic hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea.
Gastrointestinal Disorders: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dry mouth, stomach discomfort.
Hepatobiliary Disorders: Hepatic function abnormal/liver disorder*
*Most
cases of hepatic function abnormal/liver disorder from post-marketing
experience with telmisartan occurred in patients in Japan, who are more
likely to experience these adverse reactions.
Skin and Subcutaneous Tissue Disorders: Pruritus, hyperhidrosis, rash, angioedema (with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption.
Musculoskeletal, Connective Tissue and Bone Disorders: Back pain, muscle spasms (cramps in legs), myalgia, arthralgia, pain in extremity (leg pain), tendon pain (tendinitis like symptoms).
Renal and Urinary Disorders: Renal impairment including acute renal failure (see Precautions).
General Disorders and Administration Site Conditions: Chest pain, asthenia (weakness), influenza-like illness.
Investigations: Blood creatinine increased, haemoglobin decreased, blood uric acid increased, hepatic enzymes increased, blood creatine phosphokinase (CPK) increased.
