ADVERSE REACTIONS
MICARDIS tablets have been evaluated for safety in more than 3700 patients, including 1900 treated for over six months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
In placebo-controlled trials involving 1041 patients treated with various doses of telmisartan (20-160 mg) monotherapy for up to 12 weeks, an overall incidence of adverse events similar to that of placebo was observed.
Adverse events occurring at an incidence of 1% or more in patients treated with telmisartan and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in the following table.
| | Telmisartan
n = 1455
% | Placebo
n = 380
% |
| Upper respiratory tract infection | 7 | 6 |
| Back pain | 3 | 1 |
| Sinusitis | 3 | 2 |
| Diarrhea | 3 | 2 |
| Pharyngitis | 1 | 0 |
In addition to the adverse events in the table, the following events occurred at a rate of 1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea and peripheral edema. Discontinuation of therapy due to adverse events was required in 2.8% of 1455 patients treated with Micardis® (telmisartan) tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.
The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.
The incidence of cough occurring with telmisartan in six placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).
In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with MICARDIS tablets monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to MICARDIS tablets:
Autonomic Nervous System : impotence, increased sweating, flushing; Body as a Whole : allergy, fever, leg pain, malaise; Cardiovascular : palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG; CNS : insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoaesthesia; Gastrointestinal : flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders; Metabolic : gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal : arthritis, arthralgia, leg cramps; Psychiatric : anxiety, depression, nervousness; Resistance Mechanism : infection, fungal infection, abscess, otitis media; Respiratory : asthma, bronchitis, rhinitis, dyspnea, epistaxis; Skin : dermatitis, rash, eczema, pruritus; Urinary : micturition frequency, cystitis; Vascular : cerebrovascular disorder; and Special Senses : abnormal vision, conjunctivitis, tinnitus, earache.
During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).
Clinical Laboratory Findings
In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of MICARDIS tablets.
Hemoglobin : A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% telmisartan patients compared with 0.3% placebo patients. No patients discontinued therapy due to anemia.
Creatinine : A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients compared with 0.3% placebo patients. One telmisartan-treated patient discontinued therapy due to increases in creatinine and blood urea nitrogen.
Liver Enzymes : Occasional elevations of liver chemistries occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients discontinued therapy due to abnormal hepatic function.
Cardiovascular Risk Reduction Trials
In clinical studies with patients at high risk of developing major cardiovascular events, cases of sepsis, including some with fatal outcomes, have been reported.
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of Micardis® (telmisartan) tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to MICARDIS tablets. The most frequently spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, and tendon pain (including tendonitis, tenosynovitis).
Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including MICARDIS tablets.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO MICARDIS
Below is a sample of reports where side effects / adverse reactions may be related to Micardis. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Micardis side effects / adverse reactions in 77 year old male
Reported by a consumer/non-health professional from Germany on 2007-01-08
Patient: 77 year old male
Reactions: Weight Decreased, Gamma-Glutamyltransferase Increased, Diarrhoea, Nausea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Anorexia
Suspect drug(s):
Carvedilol
Dosage: 2.5mg per day
Indication: Essential Hypertension
Start date: 2005-10-21
End date: 2005-12-23
Micardis
Indication: Essential Hypertension
Start date: 2005-06-08
End date: 2005-12-23
Ramipril
Dosage: 2.5mg per day
Indication: Essential Hypertension
Start date: 2005-12-06
End date: 2005-12-23
Possible Micardis side effects / adverse reactions in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2007-01-09
Patient: female weighing 118.0 kg (259.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Nexium
Administration route: Oral
Indication: Oesophageal Disorder
Micardis
Administration route: Oral
Indication: Essential Hypertension
Voltaren
Indication: Osteoarthritis
End date: 2006-08-11
Allopurinol Sodium
Administration route: Oral
Indication: Gout
Profloxin
Administration route: Oral
Start date: 2006-08-07
End date: 2006-08-11
Gentamicin Sulfate
Start date: 2006-08-07
End date: 2006-08-10
Possible Micardis side effects / adverse reactions in 83 year old male
Reported by a physician from France on 2007-01-11
Patient: 83 year old male
Reactions: Congestive Cardiomyopathy, Hyperthyroidism
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Micardis
Other drugs received by patient: Aspirin; Omeprazole; Temgesic; Nitroderm; Hemigoxine Nativelle
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