TeliGen-40/TeliGen-80 Adverse Reactions

The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in controlled clinical trials in patients treated for hypertension. The incidence of adverse event 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 prevention of cardiovascular morbidity and mortality 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 prevention of cardiovascular morbidity and mortality for up to six years.
Infections and infestations: Urinary tract infection (including cystitis) upper respiratory tract infections, sepsis included 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: Anxiety, insomnia, depression.
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.
Gastro-intestinal disorders: Abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, stomach discomfort, vomiting.
Hepatobiliary disorder: 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 fetal 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 tract disorders: Renal impairment including acute renal failure.
General disorders and administration site conditions: Chest pain, influenza-like illness, asthenia (weakness).
Investigations: Blood creatinine increased, haemoglobin decreased, blood uric acid increased, hepatic enzymes increased, blood creatine phosphokinase (CPK) increased.