Adverse events like back pain, sinusitis, diarrhea, pharyngitis occurred at an incidence of ≥1% in patients treated with telmisartan and at a greater rate than in patients treated with placebo, irrespective of their causal association.
In addition, 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. The incidence of adverse events is not dose-related and do not correlate with gender, age or race of patients.
The incidence of cough occurring with telmisartan was identical to that noted for placebo-treated patients (1.6%).
The following adverse events were reported at a rate of ≥2% in patients treated with telmisartan/hydrochlorothiazide, but were as, or more common in the placebo group: Pain, headache, cough, urinary tract infection.
The following adverse events were reported at a rate <2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo: Back pain, dyspepsia, vomiting, tachycardia, hypokalemia, bronchitis, pharyngitis, rash, postural hypotension and abdominal pain.
Adverse events occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.
Other adverse experiences that have been reported with telmisartan, without regard to causality, are listed as follows: Autonomic Nervous System:
Impotence, increased sweating, flushing.
Body as a Whole:
Allergy, fever, leg pain, malaise, chest pain.
Palpitation, dependent and leg edema, angina pectoris, abnormal ECG, hypertension, peripheral edema.
Central Nervous System:
Insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoaesthesia.
Flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, nonspecific gastrointestinal disorders.
Gout, hypercholesterolemia, diabetes mellitus.
Arthritis, arthralgia, leg cramps, myalgia.
Anxiety, depression, nervousness.
Infection, fungal infection, abscess, otitis media.
Asthma, rhinitis, dyspnea, epistaxis.
Dermatitis, eczema, pruritus.
Micturition frequency, cystitis.
Abnormal vision, conjunctivitis, tinnitus, earache.
A single case of angioedema was reported (among a total of 3781 patients treated with telmisartan).
Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed as follows: Body as a Whole:
Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.
Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.
Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions.
Hyperglycemia, glycosuria, hyperuricemia.
Renal failure and dysfunction, interstitial nephritis.
Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.
Transient blurred vision, xanthopsia.