MedeliX
Start asking

Acamprosate

Campral · ATC code N07BB03

Also known as: Acamprosat, Akamprosat

Key facts
Active substance
Acamprosate
ATC code
N07BB03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Acamprosate (as acamprosate calcium) is used, per the US prescribing information, to maintain abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.

What it is used for

  • Maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at the start of treatment.
  • Treatment should be part of a comprehensive management program that includes psychosocial support.
  • Efficacy has not been shown in patients who have not undergone detoxification and achieved abstinence, and has not been adequately assessed in polysubstance abusers.

Dosing

  • Usual dose: two 333 mg delayed-release tablets (666 mg per dose) taken three times daily; a lower dose may be effective in some patients.
  • May be taken without regard to meals; dosing with meals is suggested in patients who regularly eat three meals daily.
  • Start as soon as possible after alcohol withdrawal, once abstinence is achieved, and continue if the patient relapses.
  • Moderate renal impairment (creatinine clearance 30 to 50 mL/min): starting dose of one 333 mg tablet three times daily.

Contraindications

  • Hypersensitivity to acamprosate calcium or any of its components.
  • Severe renal impairment (creatinine clearance ≤30 mL/min).

Important warnings

  • Renal impairment: moderate impairment requires a dose reduction; in elderly patients it may be useful to monitor renal function.
  • Suicidality and depression: suicidal events were infrequent overall but more common with acamprosate than placebo (1.4% vs. 0.5% in studies of 6 months or less; 2.4% vs. 0.8% in year-long studies); patients and caregivers should watch for depression and suicidal thinking.
  • Acamprosate does not eliminate or diminish alcohol withdrawal symptoms.

Side effects

  • Most common in controlled trials: diarrhea (16% in the pooled acamprosate group vs. 10% with placebo).
  • Other common events: asthenia, flatulence, nausea, anxiety, depression, dizziness, insomnia, pruritus.
  • Serious: suicidality and depression, and acute kidney failure (reported after marketing).

Interactions

  • Acamprosate does not affect the pharmacokinetics of alcohol, and its own pharmacokinetics are not affected by alcohol, diazepam or disulfiram.
  • No clinically important interactions between naltrexone and acamprosate were observed.
  • Patients also taking antidepressants more commonly reported both weight gain and weight loss.

Pregnancy and breastfeeding

  • Acamprosate was teratogenic in rats and rabbits; it is not known whether it passes into human milk – see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • CampralKohlpharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • CampralMERCK İLAÇ ECZA VE KİMYA TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 2 more European countries
Poland
Campral
Spain
Campral

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. ACAMPROSATE CALCIUM (Somerset Therapeutics, LLC) – Prescribing Information, 2026-07-14. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.