Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with acamprosate calcium in 20 clinical trials (4461 patients treated with acamprosate calcium, 3526 of whom received the maximum recommended dose of 1998 mg/day for up to one year in duration). This listing does not include those events already listed above; events for which a drug cause was considered remote; event terms which were so general as to be uninformative; and events reported only once which were not likely to be acutely life-threatening.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the summary of adverse events in controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Body as a Whole –Frequent: headache, abdominal pain, back pain, infection, flu syndrome, chest pain, chills, suicide attempt;
Infrequent: fever, intentional overdose, malaise, allergic reaction, abscess, neck pain, hernia, intentional injury;
Rare: ascites, face edema, photosensitivity reaction, abdomen enlarged, sudden death.
Cardiovascular System –Frequent: palpitation, syncope;
Infrequent: hypotension, tachycardia, hemorrhage, angina pectoris, migraine, varicose vein, myocardial infarct, phlebitis, postural hypotension;
Rare: heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis, shock.
Digestive System –Frequent: vomiting, dyspepsia, constipation, increased appetite;
Infrequent: liver function tests abnormal, gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, liver cirrhosis, esophagitis, hematemesis, nausea and vomiting, hepatitis;
Rare:melena, stomach ulcer, cholecystitis, colitis, duodenal ulcer, mouth ulceration, carcinoma of liver.
Endocrine System –Rare:goiter, hypothyroidism.
Hemic and Lymphatic System –Infrequent: anemia, ecchymosis, eosinophilia, lymphocytosis, thrombocytopenia;
Rare:leukopenia, lymphadenopathy, monocytosis.
Metabolic and Nutritional Disorders –Frequent– peripheral edema, weight gain;
Infrequent: weight loss, hyperglycemia, SGOT increased, SGPT increased, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia;
Rare:alkaline phosphatase increased, creatinine increased, hyponatremia, lactic dehydrogenase increased.
Musculoskeletal System –Frequent– myalgia, arthralgia;
Infrequent: leg cramps;
Rare:rheumatoid arthritis, myopathy.
Nervous System –Frequent–somnolence, libido decreased, amnesia, thinking abnormal, tremor, vasodilatation, hypertension;
Infrequent: convulsion, confusion, libido increased, vertigo, withdrawal syndrome, apathy, suicidal ideation, neuralgia, hostility, agitation, neurosis, abnormal dreams, hallucinations, hypesthesia;
Rare: alcohol craving, psychosis, hyperkinesia, twitching, depersonalization, increased salivation, paranoid reaction, torticollis, encephalopathy, manic reaction.
Respiratory System –Frequent: rhinitis, cough increased, dyspnea, pharyngitis, bronchitis;
Infrequent: asthma, epistaxis, pneumonia;
Rare:laryngismus, pulmonary embolus.
Skin and Appendages –Frequent: rash;
Infrequent: acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis, vesiculobullous rash;
Rare:psoriasis.
Special Senses –Frequent: abnormal vision, taste perversion;
Infrequent: tinnitus, amblyopia, deafness;
Rare:ophthalmitis, diplopia, photophobia.
Urogenital System –Frequent: impotence;
Infrequent– metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormal, urinary incontinence, vaginitis;
Rare:kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria, urinary urgency.
