BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

N/A

Manufactured by INDIVIOR INC.

59,605 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by INDIVIOR INC.. The most commonly reported adverse reactions for BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE include DRUG DEPENDENCE, DRUG WITHDRAWAL SYNDROME, PAIN, OFF LABEL USE, OVERDOSE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE.

Top Adverse Reactions

DRUG DEPENDENCE4,275 reports
DRUG WITHDRAWAL SYNDROME3,327 reports
PAIN2,543 reports
OFF LABEL USE2,061 reports
OVERDOSE1,850 reports
NAUSEA1,627 reports
EMOTIONAL DISTRESS1,472 reports
ANXIETY1,348 reports
VOMITING1,336 reports
HEADACHE1,109 reports
DRUG ABUSE1,098 reports
INSOMNIA1,077 reports
FOETAL EXPOSURE DURING PREGNANCY1,044 reports
INTENTIONAL UNDERDOSE1,026 reports
DEPRESSION1,024 reports
FEELING ABNORMAL1,013 reports
SUBSTANCE ABUSE1,001 reports
PRODUCT USE ISSUE977 reports
DRUG WITHDRAWAL SYNDROME NEONATAL902 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS791 reports
PRODUCT PREPARATION ERROR775 reports
FATIGUE772 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION765 reports
MATERNAL EXPOSURE DURING PREGNANCY734 reports
MALAISE726 reports
HYPERHIDROSIS711 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS661 reports
DRUG INEFFECTIVE643 reports
DENTAL CARIES630 reports
DIARRHOEA629 reports
SUICIDAL IDEATION617 reports
SOMNOLENCE537 reports
INTENTIONAL PRODUCT MISUSE511 reports
DYSPNOEA503 reports
DIZZINESS493 reports
TREMOR480 reports
CONSTIPATION453 reports
ASTHENIA440 reports
DECREASED APPETITE438 reports
BACK PAIN436 reports
TOXICITY TO VARIOUS AGENTS434 reports
CONDITION AGGRAVATED426 reports
MENTAL DISORDER426 reports
WEIGHT DECREASED423 reports
FALL419 reports
WITHDRAWAL SYNDROME398 reports
ROAD TRAFFIC ACCIDENT396 reports
DEATH395 reports
LOSS OF CONSCIOUSNESS390 reports
CONVULSION348 reports
PAIN IN EXTREMITY336 reports
TOOTH LOSS330 reports
INTENTIONAL PRODUCT USE ISSUE325 reports
RASH322 reports
HALLUCINATION316 reports
ARTHRALGIA311 reports
DISABILITY311 reports
ABDOMINAL PAIN UPPER302 reports
DRUG EXPOSURE DURING PREGNANCY302 reports
EUPHORIC MOOD301 reports
THERAPEUTIC RESPONSE UNEXPECTED296 reports
PNEUMONIA288 reports
OEDEMA PERIPHERAL285 reports
DEVELOPMENTAL DELAY279 reports
TOOTH EROSION273 reports
DEPENDENCE271 reports
MUSCLE SPASMS270 reports
HYPERSENSITIVITY269 reports
HOSPITALISATION266 reports
SEIZURE266 reports
UNEVALUABLE EVENT266 reports
ADVERSE EVENT260 reports
LEARNING DISABILITY258 reports
DRUG DETOXIFICATION256 reports
MIGRAINE256 reports
ABDOMINAL PAIN250 reports
ABDOMINAL DISCOMFORT246 reports
ABORTION SPONTANEOUS244 reports
TOOTH FRACTURE242 reports
TOOTHACHE240 reports
CONFUSIONAL STATE238 reports
THERAPY CESSATION238 reports
IRRITABILITY237 reports
STOMATITIS237 reports
CHILLS235 reports
CHEST PAIN231 reports
WEIGHT INCREASED231 reports
TOOTH DISORDER229 reports
PRURITUS228 reports
DRUG INTERACTION220 reports
HYPERTENSION207 reports
INJURY197 reports
MEMORY IMPAIRMENT197 reports
AGITATION193 reports
URTICARIA193 reports
HYPOAESTHESIA192 reports
PYREXIA190 reports
PANIC ATTACK189 reports
SUICIDE ATTEMPT189 reports
AMNESIA187 reports

Report Outcomes

Out of 23,702 classified reports for BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE:

Serious 63.5%Non-Serious 36.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female9,991 (49.8%)
Male9,979 (49.7%)
Unknown100 (0.5%)

Reports by Age

Age 30409 reports
Age 35322 reports
Age 32319 reports
Age 34310 reports
Age 36308 reports
Age 31305 reports
Age 33304 reports
Age 29289 reports
Age 28288 reports
Age 40285 reports
Age 25284 reports
Age 37280 reports
Age 27279 reports
Age 42274 reports
Age 38266 reports
Age 26246 reports
Age 45238 reports
Age 39236 reports
Age 24230 reports
Age 41216 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE?

This profile reflects 59,605 FDA FAERS reports that mention BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG DEPENDENCE, DRUG WITHDRAWAL SYNDROME, PAIN, OFF LABEL USE, OVERDOSE, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE?

Labeling and FAERS entries often list INDIVIOR INC. in connection with BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.