Drug Safety Information for BUTRANS (Buprenorphine)

REMS for Sublocade (BUPRENORPHINE) Rx Drug: FDA Link

FDA Risk Evaluation and Mitigation Strategy REMS

REMS for Suboxone (BUPRENORPHINE) Rx Drug: FDA Link

FDA Risk Evaluation and Mitigation Strategy REMS

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

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for SUBLOCADE (BUPRENORPHINE) 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 BUTRANS (BUPRENORPHINE) 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

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

Required post-approval safety study:

A prospective, observational study designed to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid analgesics. This study must address at a minimum the following specific objectives: a. Estimate the incidence of misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain. Examine the effect of product/formulation, dose and duration of opioid use, prescriber specialty, indication, and other clinical factors (e.g., concomitant psychotropic medications, personal or family history of substance abuse, history of psychiatric illness) on the risk of misuse, abuse, and addiction. b. Evaluate and quantify other risk factors for misuse, abuse, and addiction associated with long-term use of opioid analgesics for chronic pain, including but not limited to the following: demographic factors, psychosocial/behavioral factors, medical factors, and genetic factors. Identify confounders and effect modifiers of individual risk factor/outcome relationships. Due Date: 2020-03-31

Original FDA Drug Approval Date for BUTRANS: 2010-06-30

Adverse Drug Reactions for BUTRANS* (Buprenorphine)

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 BUTRANS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective2712
2Inadequate analgesia2229
3Application site rash1953
4Nausea1782
5Application site pruritus1156
6Drug effect decreased1107
7Application site irritation1085
8Rash934
9Product adhesion issue904
10Dizziness863
11Application site erythema856
12Pain639
13Headache615
14Application site reaction548
15Application site vesicles527
16Feeling abnormal463
17Vomiting453
18Wrong technique in drug usage process447
19Application site pain420
20Drug withdrawal syndrome419

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

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

Reason # of FDA Reports
1Product used for unknown indication17820
2Pain10521
3Back pain1517
4Analgesic therapy688
5Fibromyalgia446
6Neck pain324
7Arthralgia307
8Neuralgia229
9Drug dependence108
10Intervertebral disc protrusion94

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


Types of Adverse Events for BUTRANS

Total Reports Filed with FDA: 35932


Number of FDA Adverse Event Reports by Patient Age for BUTRANS

Total Reports Filed with FDA: 35932*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Buprenorphine (Buprex, Butrans, Temgesic)

Charts are based on 35932 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 BUTRANS 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.