Campral Side Effects
Generic Name: acamprosate
Note: This page contains information about the side effects of acamprosate. Some of the dosage forms included on this document may not apply to the brand name Campral.
Not all side effects for Campral may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to acamprosate: oral tablet delayed release, oral tablet enteric coated
In addition to its needed effects, some unwanted effects may be caused by acamprosate (the active ingredient contained in Campral). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking acamprosate:More common
- Extreme feeling of sadness or emptiness
- severe depression
If any of the following symptoms of overdose occur while taking acamprosate, get emergency help immediately:
- Abdominal pain
- dry mouth
- incoherent speech
- increased urination
- metallic taste
- muscle weakness
- unusual tiredness
- weight loss
Some of the side effects that can occur with acamprosate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More Common
- feeling sad
- lack of appetite
- lack or loss of strength
- loss of interest or pleasure
- trouble concentrating
- trouble sleeping
- Accidental injury
- bloated or full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- dry mouth
- excess air or gas in stomach or intestines
- itching skin
- passing gas
For Healthcare Professionals
Applies to acamprosate: oral delayed release tablet
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 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 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 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 side effects have included anemia, ecchymosis, eosinophilia, lymphocytosis and thrombocytopenia. Leukopenia, lymphadenopathy and monocytosis have been reported rarely.
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 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 side effects have frequently included myalgia and arthralgia. Leg cramps have also been reported. Rheumatoid arthritis and myopathy have been reported rarely.
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 (the active ingredient contained in Campral)
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 side effects have rarely included goiter and hypothyroidism.
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 side effects have included allergic reaction.
Immunologic side effects have frequently included infection, flu syndrome and chills.
Ocular side effects have frequently included abnormal vision. Ophthalmitis, diplopia and photophobia have been reported rarely.
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 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 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 side effects have rarely included hepatic carcinoma.
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