Adverse reactions to nitrates mainly involve the central nervous system and cardiovascular system. Headache, the most frequent adverse effect, may be severe (persistent or transient) and is perceived as a pulsating, throbbing sensation, frequently seen early in therapy, usually diminishes rapidly and may disappear within several days to weeks of continuous therapy.
Postural hypotension may occur and may cause dizziness, weakness and other signs of cerebral ischemia. Transient flushing may also occur.
Other reported adverse events are as follows:
Body as a Whole: Asthenia, back pain, chest pain, edema, peripheral edema, fatigue, feeling of warmth, fever, flu-like symptoms, malaise, pain, rigors, syncope.
Autonomic Nervous System: Dry mouth, hot flushes.
Cardiovascular: Aggravated angina pectoris, abnormal heart sounds, arrhythmia, atrial arrhythmia and fibrillation, AV block, bradycardia, bundle-branch block, cardiac and circulatory failure, extrasystole, heart murmur, hypertension/rebound hypertension, hypotension/postural hypotension, myocardial infarction, palpitation, peripheral ischemia, tachycardia, vasospasm, reflex and ventricular tachycardia, abnormal ECG, Q-wave abnormality, T-wave changes.
Central and Peripheral Nervous System: Agitation, amnesia, anxiety, cerebrovascular disorder, confusion, decreased libido, impotence, depression, dizziness, headache/migraine, hypoesthesia, impaired concentration, insomnia, nervousness, neuritis, paresis, paresthesia, paroniria, somnolence, tremor, vertigo.
Gastrointestinal: Abdominal pain, constipation, diarrhea, gastric ulcer/hemorrhagic gastric and duodenal ulcer, dyspepsia, eructation, flatulence, gastritis, glossitis, heartburn, hemorrhoids, intestinal obstruction, loose stools, melena, nausea, pharyngeal disorder, poor appetite, tooth disorder, vomiting.
Hepatic and Biliary: Biliary pain, cholecystitis, hepatomegaly.
Metabolic and Nutritional: Diabetes mellitus, gout, hypercholesterolemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypokalemia, weight decrease, weight increase. Elevations in the following: γ-glutamyl transpeptidase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), nonprotein nitrogen.
Musculoskeletal: Arthralgia, arthritis, arthropathy, arthrosis, frozen shoulder, muscle weakness, musculoskeletal pain, myalgia, myositis, tendon disorder, torticollis.
Hematologic: Purpura, thrombocytopenia, anemia, hypochromic anemia, epistaxis, leukopenia, leukocytosis.
Reproductive: Atrophic vaginitis, female breast pain, prostatic disorder.
Respiratory: Bronchitis, bronchospasm, cough, dyspnea, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, respiratory disorder and infection, rhinitis, sinusitis.
Skin and Appendages: Allergy/allergic reaction, acne, abnormal hair texture, eczema, increased sweating, cold sweat, pruritus, rash, erythematous and psoriaform rash, skin disorder and nodule, pallor.
Urinary: Albuminuria, hematuria, glycosuria, polyuria, renal calculus, urinary bladder diverticulum, urinary tract infection.
Vascular (Extracardiac): Flushing, intermittent claudication, leg ulcer, varicose vein.
Opthalmologic: Abnormal/blurred vision, amaurosis fugax, conjunctivitis, diplopia, photophobia, ptosis.
Hearing and Vestibular: Earache, tinnitus, tympanic membrane perforation.
Others: Infection (bacterial, viral), moniliasis.