Irbezyd H (irbesartan-hydrochlorothiazide) Tablets has been evaluated for safety in 898 patients treated for essential hypertension. In clinical trials with Irbezyd H, no adverse experiences peculiar to this combination drug product have been observed. Adverse experiences have been limited to those that were reported previously with irbesartan and/or hydrochlorothiazide (HCTZ). The overall incidence of adverse experiences reported with the combination was comparable to placebo. In general, treatment with Irbezyd H was well tolerated. For the most part, adverse experiences have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of Irbezyd H therapy due to clinical adverse experiences was required in only 3.6%. This incidence was significantly less (p=0.023) than the 6.8% of patients treated with placebo who discontinued therapy.
The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group: headache, sinus abnormality, cough, URI, pharyngitis, diarrhea, rhinitis, urinary tract infection, rash, anxiety/nervousness, and muscle cramp.
Adverse events occurred at about the same rates in men and women, older and younger patients, and black and nonblack patients.
Other adverse experiences that have been reported with irbesartan, without regard to causality are listed as follows: Body as a Whole:
fever, chills, orthostatic effects, facial edema, upper extremity edema.
flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, hypotension, syncope, arrhythmic/conduction disorder, cardiorespiratory arrest, heart failure, hypertensive crisis.
pruritus, dermatitis, ecchymosis, erythema face, urticaria.
sexual dysfunction, libido change, gout.
diarrhea, constipation, gastroenteritis, flatulence, abdominal distention.
musculoskeletal trauma, extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness.
anxiety/nervousness, sleep disturbance, numbness, somnolence, vertigo, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident.
cough, upper respiratory infection, epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing.
vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis.
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, renal dysfunction, interstitial nephritis.
erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.
transient blurred vision, xanthopsia.