SUBOXONE FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 2,428 U.S. reports for SUBOXONE (BUPRENORPHINE HYDROCHLORIDE\NALOXONE HYDROCHLORIDE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS SUBOXONE Report.

Top Adverse Events Reported with SUBOXONE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	NAUSEA	475
2	VOMITING	297
3	HEADACHE	277
4	DENTAL CARIES	176
5	TOOTH LOSS	141
6	PRODUCT SUBSTITUTION ISSUE	123
7	RASH	112
8	STOMATITIS	109
9	DRUG INEFFECTIVE	95
10	WITHDRAWAL SYNDROME	91
11	EXCESS SWEATING	87
12	PAIN	87
13	HIVES	87
14	DRUG DEPENDENCE	85
15	TOOTH FRACTURE	81
16	MIGRAINE	76
17	ANXIETY	61
18	FATIGUE	61
19	DEPRESSION	57
20	MALAISE	54
21	DRUG WITHDRAWAL SYNDROME	53
22	ITCHING	53
23	TOOTH DISORDER	53
24	SHORTNESS OF BREATH	52
25	DIARRHEA	50

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SUBOXONE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
889	1388	151	2,428

Medwatch Reporter Type	Count
Consumer	790
Physician	423
Pharmacist	128
Other Health Professional	716

Top Indications

Drug dependence
Product used for unknown indication
Drug use disorder
Pain
Dependence

Type of Outcome Reported
Serious: 1695
Not Serious: 733
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 2426
Concomitant Drugs: 843
Note: A single MedWatch report can list more than one drug. This summary includes SUBOXONE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

Suboxone (BUPRENORPHINE) Rx Drug:
REMS

FDA Risk Evaluation and Mitigation Strategy REMS

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

Have experience (good or bad) with SUBOXONE? Rate SUBOXONE at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.