Prescription medication · GABA Analog (Alcohol Dependence)
acamprosate
Also sold as Campral. Acamprosate helps people who are alcohol-dependent to not drink alcohol.
Data updated 2026-05-15
- 299
- FDA reportsRarely reported
- 3
- InteractionsFew interactions
- $0.36
- Generic price (NADAC)
What the data shows
acamprosate (Campral) is a prescription GABA Analog (Alcohol Dependence), among the least-reported drugs the FDA tracks (299 FDA reports), with 3 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
acamprosate (Campral) is a prescription GABA Analog (Alcohol Dependence). Acamprosate helps people who are alcohol-dependent to not drink alcohol.
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking. It should be used with counseling and support.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.36/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Acamprosate helps people who are alcohol-dependent to not drink alcohol.
Common side effects
Accidental injury, Weakness, Pain
Key warnings
Acamprosate may increase the risk of suicidal thoughts or actions.
The sections below are summarized in plain English from acamprosate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Acamprosate is similar to a natural substance in your brain. It is thought to work by helping to restore the normal balance of brain activity that is changed by long-term alcohol use. This can reduce your craving for alcohol.
How to Take It
Take two 333 mg tablets three times a day, for a total of 666 mg per dose. You can take it with or without food, but it is best to take it with meals if you eat three meals a day. Start taking acamprosate as soon as possible after you stop drinking alcohol. Keep taking it even if you have a relapse.
This is a plain-language summary of acamprosate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Acamprosate may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if acamprosate passes into breast milk. Talk to your doctor if you are breastfeeding.
This is a plain-language summary of acamprosate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of acamprosate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68° to 77°F) in a tightly closed container.
Side Effects (from patient reports)
Based on 299 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for acamprosate, by number of reports
- Low blood pressure
Low blood pressure
14 reports
- Weakness
Weakness
13 reports
- Condition worsened
Condition worsened
13 reports
- Sudden kidney damage
Sudden kidney damage
12 reports
- Prolonged unconsciousness
Prolonged unconsciousness
12 reports
- Tiredness
Tiredness
11 reports
- Harm from different substances
Harm from different substances
11 reports
- Misuse of drugs
Misuse of drugs
10 reports
- Headache
Headache
10 reports
- Slow heart rate
Slow heart rate
9 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for acamprosate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where acamprosate sits
acamprosate has more FDA adverse-event reports than 2% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is acamprosate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 299 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.
Total Reports
299
Reports Mentioning Death
25
8.4% of reports — not proof of cause
Hospitalization Reports
144
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | HYPOTENSION | 14 |
| 2 | ASTHENIA | 13 |
| 3 | CONDITION AGGRAVATED | 13 |
| 5 | ACUTE KIDNEY INJURY | 12 |
| 6 | COMA | 12 |
| 7 | FATIGUE | 11 |
| 8 | TOXICITY TO VARIOUS AGENTS | 11 |
| 9 | DRUG ABUSE | 10 |
| 10 | HEADACHE | 10 |
| 11 | BRADYCARDIA | 9 |
| 12 | CYTOLYTIC HEPATITIS | 9 |
| 13 | DEPRESSION | 9 |
| 14 | HEPATIC CYTOLYSIS | 9 |
| 15 | HYPOGLYCAEMIA | 9 |
| 16 | NEUTROPENIA | 9 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Acamprosate may increase the risk of suicidal thoughts or actions. Your doctor should watch you for depression or suicidal thoughts. Tell your doctor right away if you have any new or worsening symptoms of depression or suicidal thoughts.
Known Drug Interactions
The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [ see Clinical Pharmacology (12.3) ].
Mechanism: Diazepam does not change the way your body absorbs or uses acamprosate. These drugs do not have a known interaction that affects their levels in the blood.
What to do: No special precautions or dose changes are needed when taking these two medicines together.
The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [ see Clinical Pharmacology (12.3) ].
Mechanism: These two drugs do not significantly change how the other works in your body.
What to do: You can take these medicines together as no major issues have been found.
The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [ see Clinical Pharmacology (12.3) ].
Mechanism: Disulfiram does not change the way your body breaks down or uses acamprosate.
What to do: No special changes are usually needed when taking these two drugs at the same time.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drink alcohol while taking acamprosate?
What if I have kidney problems?
Will acamprosate cure my alcoholism?
How long will I need to take acamprosate?
Can I stop taking acamprosate suddenly?
Does acamprosate interact with other medications?
What should I do if I feel depressed or suicidal?
Can I drive or operate machinery while taking acamprosate?
What are the ingredients in acamprosate?
How should I dispose of unused acamprosate?
What are the common side effects of acamprosate?
Does acamprosate interact with other medications?
What drug class is acamprosate?
Is acamprosate safe during pregnancy?
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What the FDA Data Shows for acamprosate
The FDA label for acamprosate (sold under brand names such as Campral) classifies it as a prescription-only medication in the GABA Analog (Alcohol Dependence) class. Acamprosate helps people who are alcohol-dependent to not drink alcohol. Official labeling lists 15 commonly reported side effects, including Accidental injury, Weakness, Pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 299 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.36.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 6, 2023
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages