Drug Safety Information for NALTREXONE Hydrochloride (Naltrexone hydrochloride)

Adverse Drug Reactions for NALTREXONE Hydrochloride* (Naltrexone hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NALTREXONE Hydrochloride
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea84
2Vomiting76
3Drug ineffective*72
4Diarrhoea65
5Asthenia54
6Depression*53
7Fatigue*52
8Anxiety46
9Headache45
10Drug interaction44
11Hyperhidrosis44
12Pain43
13Confusional state42
14Agitation42
15Toxicity to various agents40
16Dyspnoea39
17Dizziness38
18Pain in extremity38
19Malaise38
20Drug withdrawal syndrome37

* This side effect also appears in "Top 10 Side Effects of NALTREXONE Hydrochloride " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NALTREXONE Hydrochloride
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication844
2Alcoholism*228
3Drug dependence*186
4Drug detoxification81
5Multiple sclerosis*62
6Rheumatoid arthritis60
7Alcohol abuse*56
8Detoxification46
9Pain40
10Crohn's disease*33

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for NALTREXONE Hydrochloride

Total Reports Filed with FDA: 6000


Number of FDA Adverse Event Reports by Patient Age for NALTREXONE Hydrochloride

Total Reports Filed with FDA: 6000*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Naltrexone hydrochloride (Revia, Naltrexone)

Charts are based on 6000 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and NALTREXONE Hydrochloride Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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