Drug Safety Information for BUPRENEX (Buprenorphine hydrochloride)

REMS for Belbuca (BUPRENORPHINE HYDROCHLORIDE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for BELBUCA (BUPRENORPHINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for BUPRENEX (BUPRENORPHINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for SUBUTEX (BUPRENORPHINE HYDROCHLORIDE) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for BUNAVAIL (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for BUPRENEX* (Buprenorphine 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 BUPRENEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug withdrawal syndrome neonatal533
2Substance abuse368
3Nausea*336
4Vomiting329
5Intentional drug misuse322
6Drug withdrawal syndrome302
7Drug abuse282
8Toxicity to various agents252
9Anxiety237
10Drug interaction225
11Abortion spontaneous220
12Death212
13Premature baby209
14Wrong technique in drug usage process200
15Exposure during breast feeding190
16Suicidal ideation186
17Pain183
18Overdose182
19Drug dependence181
20Depression*178

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

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

Reason # of FDA Reports
1Product used for unknown indication7360
2Drug dependence6272
3Pain*1472
4Back pain*247
5Drug withdrawal maintenance therapy216
6Analgesic therapy184
7Drug abuse177
8Drug therapy156
9Maternal exposure during pregnancy114
10Pain management108

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


Types of Adverse Events for BUPRENEX

Total Reports Filed with FDA: 25854


Number of FDA Adverse Event Reports by Patient Age for BUPRENEX

Total Reports Filed with FDA: 25854*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Buprenorphine hydrochloride (Buprenorphine hcl, Buprenorfina, Buprenorphine, Subutex, Buprenex)

Charts are based on 25854 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 BUPRENEX 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.

Visit   DrugInformer.com more on BUPRENEX's side effects.