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Campral

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Campral

Campral

Campral Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Campral (acamprosate calcium) is used to help alcohol-dependent patients keep from drinking alcohol. It should be used as part of a complete treatment program that includes both counseling and psychological support. It is believed to work by restoring the natural balance of chemicals in the brain (neurotransmitters). Campral is unlikely to be helpful to a person who has not already quit drinking or undergone detoxification. It may not be helpful to a person who is also addicted to other substances besides alcohol. Common side effects include diarrhea, nausea, vomiting, gas, stomach pain, loss of appetite, headache, drowsiness, dizziness, constipation, fatigue, weight gain/loss, muscle/joint pain, change in sexual desire or decreased sexual ability. Suicidal thoughts may occur during treatment. Tell your doctor if you feel depressed or have any suicidal thoughts or actions.

The recommended dose of Campral is two 333 mg tablets (each dose should total 666 mg) taken three times daily. There may be other drugs that can interact with Campral. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Campral should be used only when prescribed during pregnancy. Drinking large amounts of alcohol during pregnancy can cause long-lasting problems (often called fetal alcohol syndrome) in your baby, such as birth defects, growth retardation, and learning disabilities. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Campral (acamprosate calcium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Campral in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effects such as:

  • mood or behavior changes;
  • thoughts about hurting yourself;
  • severe anxiety or depression;
  • feeling like you might pass out;
  • fast or pounding heartbeats;
  • swelling, weight gain, feeling short of breath;
  • confusion, increased thirst; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation, diarrhea;
  • headache, dizziness, drowsiness;
  • vision problems;
  • problems with memory or thinking;
  • weakness, cold or flu-like symptoms;
  • back pain, joint or muscle pain;
  • dry mouth, decreased or distorted sense of taste;
  • sleep problems (insomnia);
  • impotence, loss of interest in sex;
  • sweating, mild skin rash; or
  • numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Campral (Acamprosate Calcium) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Campral Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, nausea, vomiting, gas, stomach pain, loss of appetite, headache, drowsiness, dizziness, constipation, fatigue, weight gain/loss, muscle/joint pain, change in sexual desire or decreased sexual ability may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (including severe depression, thoughts of suicide), fainting, fast or pounding heartbeat, vision or hearing changes, increased thirst.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, seizures, persistent stomach pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Campral (Acamprosate Calcium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Campral FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinically significant serious adverse reactions associated with Campral described elsewhere in labeling include suicidality and depression and acute kidney failure [see WARNINGS AND PRECAUTIONS].

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 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.

Table 1: Events Occurring at a Rate of at Least 3% and Greater than Placebo in any Campral Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events.

Body System/
Preferred Term
Number of Patients (%) with Events
Campral 1332 mg/day Campral 1998 mg/day1 Campral Pooled2 Placebo
Number of patients in Treatment Group 397 1539 2019 1706
Number (%) of patients with an AE 248 (62%) 910 (59%) 1231 (61%) 955 (56%)
Body as a Whole 121 (30%) 513 (33%) 685 (34%) 517 (30%)
  Accidental Injury*† 17 ( 4%) 44 ( 3%) 70 ( 3%) 52 ( 3%)
  Asthenia 29 ( 7%) 79 ( 5%) 114 ( 6%) 93 ( 5%)
  Pain 6 ( 2%) 56 ( 4%) 65 ( 3%) 55 ( 3%)
Digestive System 85 (21%) 440 (29%) 574 (28%) 344 (20%)
  Anorexia 20 ( 5%) 35 ( 2%) 57 ( 3%) 44 ( 3%)
  Diarrhea 39 (10%) 257 (17%) 329 (16%) 166 (10%)
  Flatulence 4 ( 1%) 55 ( 4%) 63 ( 3%) 28 ( 2%)
  Nausea 11 ( 3%) 69 ( 4%) 87 ( 4%) 58 ( 3%)
Nervous System 150 (38%) 417 (27%) 598 (30%) 500 (29%)
  Anxiety††** 32 ( 8%) 80 ( 5%) 118 ( 6%) 98 ( 6%)
  Depression 33 ( 8%) 63 ( 4%) 102 ( 5%) 87 ( 5%)
  Dizziness 15 ( 4%) 49 ( 3%) 67 ( 3%) 44 ( 3%)
  Dry mouth 13 ( 3%) 23 ( 1%) 36 ( 2%) 28 ( 2%)
  Insomnia 34 ( 9%) 94 ( 6%) 137 ( 7%) 121 ( 7%)
  Paresthesia 11 ( 3%) 29 ( 2%) 40 ( 2%) 34 ( 2%)
Skin and Appendages 26 ( 7%) 150 (10%) 187 ( 9%) 169 (10%)
  Pruritus 12 ( 3%) 68 ( 4%) 82 ( 4%) 58 ( 3%)
  Sweating 11 ( 3%) 27 ( 2%) 40 ( 2%) 39 ( 2%)
†*includes events coded as “fracture” by sponsor;
††**includes events coded as “nervousness” by sponsor
1 includes 258 patients treated with acamprosate calcium 2000 mg/day, using a different dosage strength and regimen.
2 includes all patients in the first two columns as well as 83 patients treated with acamprosate calcium 3000 mg/day, using a different dosage strength and regimen.

Concomitant Therapies

In clinical trials, the safety profile in subjects treated with Campral concomitantly with anxiolytics, hypnotics and sedatives (including benzodiazepines), or non-opioid analgesics was similar to that of subjects taking placebo with these concomitant medications. Patients taking Campral concomitantly with antidepressants more commonly reported both weight gain and weight loss, compared with patients taking either medication alone.

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.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Campral. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

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.

Read the entire FDA prescribing information for Campral (Acamprosate Calcium) »

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Campral - User Reviews

Campral User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Campral sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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