Telstran Adverse Reactions

Summary of the safety profile: Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely and acute renal failure.
List of adverse reactions: Adverse reactions have been ranked under headings of frequency using the following convention: very common; common; uncommon; rare; very rare.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations: Uncommon: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis. Rare: Sepsis including fatal outcome.
Blood and the lymphatic system disorders: Uncommon: Anaemia. Rare: Eosinophilia, thrombocytopenia.
Immune system disorders: Rare: Anaphylactic reaction, hypersensitivity.
Metabolism and nutrition disorders: Uncommon: Hyperkalaemia. Rare: Hypoglycaemia (in diabetic patients).
Psychiatric disorders: Uncommon: Insomnia, depression. Rare: Anxiety.
Nervous system disorders: Uncommon: Syncope. Rare: Somnolence.
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, cough. Very rare: Interstitial lung disease.
Gastrointestinal disorders: Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting. Rare: Dry mouth, stomach discomfort, dysgeusia.
Hepatobiliary disorders: Rare: Hepatic function abnormal/liver disorder.
Skin and subcutaneous tissue disorders: Uncommon: Pruritus, hyperhidrosis, rash. Rare: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption.
Musculoskeletal and connective tissue disorders: Uncommon: Back pain (e.g. sciatica), muscle spasms, myalgia. Rare: Arthralgia, pain in extremity, 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: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased.
Description of selected adverse reactions: Sepsis: 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.
Hypotension: This adverse reaction was 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.
Hepatic function abnormal/liver disorder: Most cases of hepatic function abnormal/liver disorder from post-marketing experience occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
Interstitial lung disease: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan. However, a causal relationship has not been established.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.