Coversyl AM (Aceon AM)4Mg/10 Mg – 30 tablet

Some reactions occurred at an incidence of >1% but ≤ placebo.

>10%:

Central nervous system: Headache (24%)

Respiratory: Cough (12%; incidence higher in women, 3:1)

1% to 10%:

Cardiovascular: Edema (4%), chest pain (2%), ECG abnormality (2%), palpitations (1%)

Central nervous system: Hypertonia (3%), sleep disorder (3%), depression (2%), paresthesia (2%), drowsiness (1%), nervousness (1%)

Dermatologic: Skin rash (2%)

Endocrine & metabolic: Increased serum triglycerides (1%), menstrual disease (1%)

Gastrointestinal: Diarrhea (4%), abdominal pain (3%), dyspepsia (2%), nausea (2%), vomiting (2%), flatulence (1%)

Genitourinary: Urinary tract infection (3%), proteinuria (2%), sexual disorder (male: 1%)

Hepatic: Increased serum ALT (2%)

Hypersensitivity: Seasonal allergy (2%)

Infection: Viral infection (3%)

Neuromuscular & skeletal: Weakness (8%), back pain (6%), leg pain (5%), arm pain (3%), arthralgia (1%), arthritis (1%), myalgia (1%), neck pain (1%)

Otic: Tinnitus (2%), otic infection (1%)

Respiratory: Upper respiratory tract infection (9%), sinusitis (5%), rhinitis (5%), pharyngitis (3%)

Miscellaneous: Fever (2%)

<1%, postmarketing, and/or case reports: Amnesia, anaphylaxis, angioedema, anxiety, arthralgia, bronchitis, bruise, cardiac conduction disturbance, cerebrovascular accident, chills, conjunctivitis, constipation, diaphoresis, dyspnea, epistaxis, erythema, facial edema, flank pain, fluid retention, gastroenteritis, gout, heart murmur, hematoma, hematuria, hyperglycemia, hypokalemia, hypotension, increased appetite, increased serum alkaline phosphatase, increased serum AST, increased serum cholesterol, increased serum creatinine, increased uric acid, leukopenia, malaise, migraine, myocardial infarction, nephrolithiasis, neutropenia, orthostatic hypotension, otalgia, pain, pruritus, psychological disorder (psychosexual disorder), pulmonary fibrosis, purpura, rhinorrhea, sneezing, syncope, tinea, urinary frequency, urinary retention, vaginitis, vasodilation, ventricular premature contractions, vertigo, visual hallucination (Doane 2013), xeroderma, xerostomia