Drug Safety Information for SUBUTEX (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 SUBUTEX* (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 SUBUTEX
(reported in FDA Medwatch/FAERS Reports)
|Side Effect||# of FDA Reports|
|1||Drug withdrawal syndrome neonatal||533|
|5||Intentional drug misuse||322|
|6||Drug withdrawal syndrome||302|
|8||Toxicity to various agents||252|
|14||Wrong technique in drug usage process||200|
|15||Exposure during breast feeding||190|
* This side effect also appears in "Top 10 Side Effects of SUBUTEX " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking SUBUTEX
(associated with FDA Medwatch/FAERS Reports)
|Reason||# of FDA Reports|
|1||Product used for unknown indication||7360|
|5||Drug withdrawal maintenance therapy||216|
|9||Maternal exposure during pregnancy||114|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for SUBUTEX
Total Reports Filed with FDA: 25854
Number of FDA Adverse Event Reports by Patient Age for SUBUTEX
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.
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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.