>10% Central nervous system: Headache (23%)
1% to 10%:
Cardiovascular: edema (3.9%), chest pain (2.4%)
Central nervous system: Dizziness (8.2%), sleep disorders (2.5%), depression
(2%), fever (1.5%), weakness (7.9%), nervousness (1%)
Dermatologic: Rash (2.3%)
Endocrine and metabolic: Hyperkalemia (1.4%), increased triglycerides (1.3%)
Gastrointestinal: Nausea (2.3%), diarrhea (4.3%), vomiting (1.5%), dyspepsia
(1.9%), abdominal pain (2.7%), flatulence (1%)
Genitourinary: Sexual dysfunction (male: 1.4%)
Hepatic: Increased ALT (1.7%)
Neuromuscular & skeletal: Back pain (5.8%), upper extremity pain (2.8%),
lower extremity pain (4.7%), paresthesia (2.3%), joint pain (1.1%), myalgia
(1.1%), arthritis (1%)
Renal: Proteinuria (1.5%)
Respiratory: Cough (incidence is higher in women, 3:1) (12%), sinusitis
(5.2%), rhinitis (4.8%), pharyngitis (3.3%)
Otic: Tinnitus (1.5%)
Miscellaneous: Viral infection (3.4%)
Note: Some reactions occurred at an incidence >1% but less than or
equal to placebo:
<1% (Limited to important or life-threatening symptoms): Angioedema
(0.1%), anaphylaxis, facial edema, malaise, pain, chills, orthostatic
hypotension, constipation, xerostomia, increased appetite, gastroenteritis,
bronchitis, rhinorrhea, dyspnea, sneezing, epistaxis, pulmonary fibrosis
(<0.1%), vaginitis, nephrolithiasis, urinary frequency, urinary retention,
flank pain, hypotension, ventricular extrasystole, myocardial infarction,
vasodilation, syncope, conduction abnormalities, gout, hematoma, bruising,
arthralgia, migraine, amnesia, vertigo, cerebral vascular accident (0.2%),
anxiety, psychosocial disorder, sweating, tines, pruritus, dry skin,
erythema,purpura (0.1%), conjunctivity, earache, hypokalemia, decreased uric
acid, increased alkaline phosphatase, increased serum creatinine, increased AST,
hematuria, and hyperglycemia.
Additional adverse effects associated with with ACE inhibitors include
agranulocytosis (especially in patients with renal impairment or collagen
vascular disease), neutropenia, decreases in creatinine clearance in some
elderly hypertensive patients or those with chronic renal failure, and worsening
of renal function in patients with bilateral renal artery stenosis or
hypovolemic patients (diuretic therapy). In addition, a syndrome which may
include fever, myalgia, arthralgia, interstitial nephritis, vasculitis, rash,
eosinophilia and positive ANA, and elevated ESR has been reported with ACE
inhibitors.