Drug Safety Information for CONTRAVE (Bupropion hydrochloride; naltrexone hydrochloride)

Safety-related Labeling Changes for CONTRAVE (BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE) Rx Drug: FDA Link

Loss of consciousness Evaluating

Adverse Drug Reactions for CONTRAVE* (Bupropion 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 CONTRAVE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea73
2Dizziness45
3Headache38
4Vomiting37
5Drug ineffective18
6Feeling abnormal16
7Diarrhoea15
8Anxiety14
9Insomnia13
10Constipation12
11Hyperhidrosis12
12Tremor10
13Urticaria10
14Palpitations9
15Abdominal pain upper9
16Convulsion9
17Suicidal ideation9
18Rash9
19Blood pressure increased8
20Fatigue8

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

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

Reason # of FDA Reports
1Weight decreased211
2Weight control171
3Overweight163
4Obesity116
5Product used for unknown indication74
6Weight loss diet12
7Depression4
8Weight increased3
9Affective disorder2
10Fibromyalgia1

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


Types of Adverse Events for CONTRAVE

Total Reports Filed with FDA: 798


Number of FDA Adverse Event Reports by Patient Age for CONTRAVE

Total Reports Filed with FDA: 798*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bupropion hydrochloride; naltrexone hydrochloride (Contrave)

Charts are based on 798 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 CONTRAVE Reviews and Review Summary .

Historical 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.