Micardis/Micardis Plus Adverse Reactions

Micardis: 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 Micardis 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 hypertensive patients treated with telmisartan and from post-marketing reports. The listing also takes into account serious adverse events leading to discontinuation reported in 3 clinical long-term studies including 21642 patients treated with telmisartan for prevention of cardiovascular morbidity and mortality for up to 6 years.
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, diarrhea, dyspepsia, flatulence, vomiting, dry mouth, stomach upset.
Hepatobilary Disorders: Abnormal hepatic function/liver disorder*.
*Most cases of abnormal hepatic function/liver disorder from post-marketing experience with telmisartan occured 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 and 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: Increased blood creatinine, uric acid, hepatic enzymes, blood creatine phosphokinase (CPK), decreased hemoglobin.
Micardis Plus: The overall incidence of adverse events reported with Micardis Plus was comparable to those reported with telmisartan alone in randomized controlled trials involving 1471 patients receiving telmisartan plus hydrochlorothiazide (835) or telmisartan (636) alone. There was no dose-relationship to undesirable effects and there was no correlation with gender, age or race of the patients.
Adverse reactions reported in clinical trials with telmisartan plus hydrochlorothiazide are shown as follows according to system organ class. Adverse reactions not observed in clinical trials with telmisartan plus hydrochlorothiazide but expected during treatment with Micardis Plus based on the experience with telmisartan or hydrochlorothiazide alone have been included and are detailed in separate sections as follows.
Infections and Infestations: Bronchitis, pharyngitis, sinusitis.
Immune System Disorders: Exacerbation or activation of systemic lupus erythematosus*.
*Based on post-marketing experience.
Metabolism and Nutrition Disorders: Hypokalaemia, hyponatraemia, hyperuricaemia.
Psychiatric Disorders: Anxiety, depression.
Nervous System Disorders: Dizziness, syncope/faint, paraesthesia, sleep disturbances, insomnia.
Eye Disorders: Abnormal vision, transient blurred vision.
Ear and Labyrinth Disorders: Vertigo.
Cardiac Disorders: Cardiac arrhythmias, tachycardia.
Vascular Disorders: Hypotension (including orthostatic hypotension).
Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea, respiratory distress (including pneumonitis and pulmonary oedema).
Gastrointestinal Disorders: Diarrhoea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia, vomiting, gastritis.
Hepatobiliary Disorders: Abnormal hepatic function/liver disorder*.
*Most cases of abnormal hepatic function/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: Angioedema (with fatal outcome), erythema, pruritus, rash, increased sweating, urticaria.
Musculoskeletal, Connective Tissue and Bone Disorders: Back pain, muscle spasm, myalgia, arthralgia, leg pain, cramps in legs.
Reproductive System and Breast Disorders: Impotence.
General Disorders and Administration Site Conditions: Chest pain, influenza-like symptoms, pain.
Investigations: Increase in uric acid, creatinine, liver enzymes, blood creatine phosphokinase.
Telmisartan: Additional side effects reported in clinical trials with telmisartan monotherapy in the indication hypertension or in patients ≥50 years at high risk of cardiovascular events were as follows: Infections and Infestations: Upper respiratory tract infections, urinary tract infections (including cystitis), sepsis including fatal outcome.
Blood and Lymphatic System Disorders: Anaemia, thrombocytopenia, eosinophilia.
Immune System Disorders: Anaphylactic reaction, hypersensitivity.
Metabolism and Nutrition Disorders: Hyperkalaemia, hypoglycaemia (in diabetic patients).
Cardiac Disorders: Bradycardia.
Gastrointestinal Disorders: Stomach upset.
Skin and Subcutaneous Tissue Disorders: Eczema, drug eruption, toxic skin eruption.
Musculoskeletal, Connective Tissue and Bone Disorders: Arthrosis, tendon pain (tendinitis like symptoms).
Renal and Urinary Disorders: Renal impairment including acute renal failure (see Warnings and Precautions).
General Disorders and Administration Site Conditions: Asthenia (weakness).
Investigations: Decrease in haemoglobin.
Hydrochlorothiazide: Additional side effects reported with hydrochlorothiazide monotherapy were as follows: Infections and Infestations: Sialadenitis.
Blood and Lymphatic System Disorders: Thrombocytopenia, aplastic anaemia, haemolytic anaemia, bone marrow depression, leukopenia, neutropenia/agranulocytosis.
Immune System Disorders: Anaphylactic reactions, allergy.
Endocrine Disorders: Loss of diabetic control.
Metabolism and Nutrition Disorders: Cause or exacerbate volume depletion, electrolyte imbalance, anorexia, loss of appetite, hyperglycaemia, hypercholesterolaemia.
Psychiatric Disorders: Restlessness.
Nervous System Disorders: Lightheadedness.
Eye Disorders: Xanthopsia, acute myopia, acute angle-closure glaucoma.
Vascular Disorders: Necrotizing angiitis (vasculitis).
Gastrointestinal Disorders: Stomach upset, pancreatitis.
Hepatobiliary Disorders: Jaundice (hepatocellular or cholestatic jaundice).
Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, cutaneous vasculitis, photosensitivity reactions.
Musculoskeletal, Connective Tissue and Bone Disorders: Weakness.
Renal and Urinary Disorders: Interstitial nephritis, renal dysfunction, glycosuria.
General Disorders and Administration Site Conditions: Fever.
Investigations: Increase in triglycerides.