Campral Side Effects

Please note - some side effects for Campral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Campral - for the Consumer

Campral

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Campral:

Diarrhea; dizziness; gas; loss of appetite; nausea; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; behavior changes; depression; mental or mood changes; nervousness; panic attacks; restlessness; suicidal thoughts or behaviors.

Campral Side Effects - for the Professional

Campral

The adverse event data described below reflect the safety experience in over 7000 patients exposed to Campral® for up to one year, including over 2000 Campral®-exposed patients who participated in placebo-controlled trials.

Adverse Events Leading to Discontinuation

In placebo-controlled trials of 6 months or less, 8% of Campral®-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both the placebo-treated and the Campral®-treated patients. Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of Campral®-treated vs. 0.7% of placebo-treated patients). Other events, including nausea, depression, and anxiety, while accounting for discontinuation in less than 1% of patients, were nevertheless more commonly cited in association with discontinuation in Campral®-treated patients than in placebo-treated patients.

Common Adverse Events Reported in Controlled Trials

Common, non-serious adverse events were collected spontaneously in some controlled studies and using a checklist in other studies. The overall profile of adverse events was similar using either method. Table 1 shows those events that occurred in any Campral® treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events. The reported frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed, without regard to the causal relationship of the events to the drug.

Other Events Observed During the Premarketing Evaluation of Campral®

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with Campral® in 20 clinical trials (4461 patients treated with Campral®, 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.

Serious Adverse Events Observed During the Non-US Postmarketing Evaluation of Campral® (acamprosate calcium)

Although no causal relationship to Campral® has been found, the serious adverse event of acute kidney failure has been reported to be temporally associated with Campral® treatment in at least 3 patients and is not described elsewhere in the labeling.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have frequently included anorexia (3%), diarrhea (16%), flatulence (3%), nausea (4%), dry mouth (2%), vomiting, dyspepsia, constipation, taste perversion, abdominal pain and increased appetite. Gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, esophagitis and hematemesis have also been reported. Melena, stomach ulcer, cholecystitis, colitis, increased salivation, duodenal ulcer, enlarged abdomen, and mouth ulceration have been reported rarely.

Diarrhea was the only side effect associated with a drop out rate of greater than 1%, when compared to placebo, in clinical studies.

Nervous system

Nervous system side effects have frequently included anxiety/nervousness (6%), dizziness (3%), insomnia (7%), paresthesia (2%), somnolence, decreased libido, amnesia, abnormal thinking and tremor. Convulsions, migraine, confusion, increased libido, vertigo, withdrawal syndrome, apathy, neuralgia and hypesthesia have also been reported. Alcohol craving, hyperkinesia, twitching, torticollis and encephalopathy have been reported rarely.

Cardiovascular

Cardiovascular side effects have frequently included palpitations, vasodilation, hypertension and syncope. Hypotension, tachycardia, hemorrhage, angina pectoris, varicose veins, myocardial infarct, phlebitis and postural hypotension have also been reported. Heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis and shock have been reported rarely.

Other

Other side effects have frequently included accidental injury/fractures (3%), asthenia (6%), pain (3%), headache, back pain, chest pain and suicide attempt. Tinnitus, deafness, fever, intentional overdose, malaise, abscess, neck pain, hernia and intentional injury have also been reported. Ascites, face edema, photosensitivity reaction and sudden death have been reported rarely.

Hematologic

Hematologic side effects have included anemia, ecchymosis, eosinophilia, lymphocytosis and thrombocytopenia. Leukopenia, lymphadenopathy and monocytosis have been reported rarely.

Genitourinary

Genitourinary side effects have frequently included impotence. Metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormality, urinary incontinence and vaginitis have also been reported. Kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria and urinary urgency have been reported rarely.

Metabolic

Metabolic side effects have frequently included peripheral edema and weight gain. Weight loss, hyperglycemia, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia have also been reported. Increased creatinine, hyponatremia and increased lactic dehydrogenase have been reported rarely. Hypercalcemia has been reported in cases of chronic overdose.

Musculoskeletal

Musculoskeletal side effects have frequently included myalgia and arthralgia. Leg cramps have also been reported. Rheumatoid arthritis and myopathy have been reported rarely.

Dermatologic

Dermatologic side effects have frequently included pruritus (4%), sweating (2%) and rash. Acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis and vesiculobullous rash have also been reported. Psoriasis has been reported rarely. There is a single case report of a possible association of erythema multiforme with acamprosate.

A 40-year-old woman with cirrhosis of the liver presented with a possible case of erythema multiforme after 10 days of therapy. While it may be probable that acamprosate was the cause, it is also possible that this outbreak could have been caused by the herpes simplex virus.

Endocrine

Endocrine side effects have rarely included goiter and hypothyroidism.

Hepatic

Hepatic side effects have frequently included increased SGOT and increased SGPT. Abnormal liver function tests, liver cirrhosis, and hepatitis have also been reported. Increases in alkaline phosphatase have been reported rarely.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction.

Immunologic

Immunologic side effects have frequently included infection, flu syndrome and chills.

Ocular

Ocular side effects have frequently included abnormal vision. Ophthalmitis, diplopia and photophobia have been reported rarely.

Renal

Renal side effects have rarely included acute kidney failure.

Acute kidney failure has been reported in at least 3 patients. While there has been no causal relationship found between these incidents and acamprosate therapy, a temporal association has been reported by the manufacturer.

Respiratory

Respiratory side effects have frequently included rhinitis, increased cough, dyspnea, pharyngitis and bronchitis. Asthma, epistaxis and pneumonia have also been reported.

Laryngismus and pulmonary embolus have been reported rarely.

Psychiatric

Psychiatric side effects have included depression (5%), suicidal ideation, hostility, agitation, neurosis, abnormal dreams and hallucinations. Psychosis, depersonalization, paranoid reaction, and manic reaction have been reported rarely.

Oncologic

Oncologic side effects have rarely included hepatic carcinoma.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.