Merit Adverse Reactions

Tabulated summary of adverse reactions: Adverse reactions have been ranked under heading 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).
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; 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: Depression, insomnia; 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: Dyspnea, cough; Very rare: Interstitial lung disease.
Gastrointestinal disorders: Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting; Rare: Stomach discomfort, dry mouth.
Hepato-biliary disorders: Rare: Hepatic function abnormal/liver disorder.
Skin and subcutaneous tissue disorders: Uncommon: Hyperhidrosis, pruritus, rash; Rare: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption.
Musculoskeletal and connective tissue disorders: Uncommon: Myalgia, back pain (e.g., sciatica), muscle spasms; Rare: Arthralgia, pain in extremity, tendon pain (tendonitis-like symptoms).
Renal and urinary disorders: Uncommon: Renal impairment including acute renal failure.
General disorders and administrative 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 creatinine phosphokinase increased, haemoglobin decreased.
1,2,3,4: For further descriptions, please see sub-section “Description of selected adverse reactions”.
Description of selected adverse reactions: 1. Sepsis: 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.
2. Hypotension: The adverse effect 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.
3. 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.
4. Hepatic function abnormal/liver disorder: Most cases of hepatic function abnormal/liver disorder from post-marketing experience occurred in patients in Japan, who are more likely to experience these adverse reactions.