Telmisar/Telmisar 80 Adverse Reactions

The overall incidence of adverse events reported with Telmisartan (41.4%) was usually comparable to placebo (43.9%) in controlled trials in patients treated for hypertension. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of Telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients. The adverse drug reactions listed as follows have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports. The listing also takes into account serious adverse events and adverse events leading to discontinuation reported in three clinical long-term studies including 21642 patients treated with Telmisartan for the reduction of cardiovascular morbidity for up to six years.
Adverse Reactions Have Been Ranked Under Headings of Frequency Using the Following Convention: 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, adverse reactions are presented in order of decreasing seriousness.
Infections and Infestations: Uncommon: Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis.
Not Known: Sepsis including fatal outcome.
Blood and the Lymphatic System Disorders: Uncommon: Anaemia.
Rare: Thrombocytopenia.
Not Known: Eosinophilia.
Immune System Disorders: Rare: Hypersensitivity.
Not Known: Anaphylactic reaction.
Metabolism and Nutrition Disorders: Uncommon: Hyperkalaemia.
Psychiatric Disorders: Uncommon: Depression, insomnia.
Rare: Anxiety.
Nervous System Disorders: Uncommon: Syncope.
Eye Disorders: Rare: Visual disturbance.
Ear and Labyrinth Disorders: Uncommon: Vertigo.
Cardiac Disorders: Uncommon: Bradycardia.
Rare: Tachycardia.
Vascular Disorders: Uncommon: Hypotension, orthostatic hypotension.
Respiratory, Thoracic, and Mediastinal Disorders: Uncommon: Dyspnoea.
Gastrointestinal Disorders: Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting.
Rare: Stomach discomfort, dry mouth.
Hepato-Biliary Disorders: Rare: Abnormal hepatic function (Liver disorder).
Skin and Subcutaneous Tissue Disorders: Uncommon: Hyperhidrosis, pruritus, rash.
Rare: Erythema, angioedema, drug eruption, toxic skin eruption, eczema.
Not Known: Urticaria.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Myalgia, back pain (e.g. sciatica), muscle spasms.
Rare: Arthralgia, pain in extremity.
Not Known: Tendon pain (tendinitis like symptoms).
Renal and Urinary Disorders: Uncommon: Renal impairment including acute renal failure.
General Disorders and Administration Site Conditions: Uncommon: Chest pain, asthenia (weakness).
Rare: Influenza-like illness.
Investigations: Uncommon: Blood creatinine increased.
Rare: Blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased, haemoglobin decreased in the PRoFESS trial, an increased incidence of sepsis was observed with Telmisartan compared with placebo. The event may be a chance finding or related to a mechanism currently not known.
Reported as common in patients with controlled blood pressure who were treated with Telmisartan for the reduction of cardiovascular morbidity on top of standard care.