BUPRENORPHINE HYDROCHLORIDE

N/A

Manufactured by BioDelivery Sciences International Inc

15,869 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BioDelivery Sciences International Inc. The most commonly reported adverse reactions for BUPRENORPHINE HYDROCHLORIDE include DEPENDENCE, OVERDOSE, DEATH, ILL-DEFINED DISORDER, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPRENORPHINE HYDROCHLORIDE.

Top Adverse Reactions

DEPENDENCE2,856 reports
OVERDOSE1,442 reports
DEATH452 reports
ILL DEFINED DISORDER405 reports
DRUG INEFFECTIVE380 reports
NAUSEA320 reports
FOETAL EXPOSURE DURING PREGNANCY295 reports
PRODUCT ADHESION ISSUE276 reports
DRUG WITHDRAWAL SYNDROME NEONATAL263 reports
PAIN259 reports
WITHDRAWAL SYNDROME244 reports
HEADACHE237 reports
OFF LABEL USE235 reports
DEPRESSION218 reports
FATIGUE216 reports
MATERNAL EXPOSURE DURING PREGNANCY210 reports
VOMITING204 reports
ANXIETY192 reports
DIZZINESS192 reports
DIARRHOEA169 reports
TOXICITY TO VARIOUS AGENTS167 reports
PRODUCT SOLUBILITY ABNORMAL161 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS160 reports
INSOMNIA154 reports
DRUG ABUSE153 reports
DYSPNOEA144 reports
ARTHRALGIA143 reports
FALL135 reports
PRODUCT DOSE OMISSION ISSUE129 reports
PRURITUS122 reports
ABDOMINAL PAIN UPPER121 reports
ASTHENIA119 reports
MALAISE116 reports
PRODUCT QUALITY ISSUE116 reports
THERAPEUTIC RESPONSE DECREASED112 reports
CONDITION AGGRAVATED111 reports
DRUG WITHDRAWAL SYNDROME109 reports
RASH108 reports
DENTAL CARIES104 reports
GASTROOESOPHAGEAL REFLUX DISEASE104 reports
PRODUCT USE ISSUE104 reports
MIGRAINE101 reports
SOMNOLENCE100 reports
PREMATURE BABY98 reports
ABDOMINAL PAIN90 reports
CONSTIPATION89 reports
PYREXIA89 reports
HYPOAESTHESIA87 reports
PNEUMONIA86 reports
PREMATURE DELIVERY86 reports
CONFUSIONAL STATE84 reports
STOMATITIS82 reports
DECREASED APPETITE80 reports
MEMORY IMPAIRMENT79 reports
ABDOMINAL DISCOMFORT78 reports
ACCIDENTAL OVERDOSE78 reports
DRUG DEPENDENCE76 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION75 reports
ASTHMA74 reports
COMA74 reports
PERIPHERAL SWELLING74 reports
GASTROINTESTINAL DISORDER72 reports
GENERAL PHYSICAL HEALTH DETERIORATION72 reports
ORAL ADMINISTRATION COMPLICATION71 reports
HYPERTENSION70 reports
INTENTIONAL PRODUCT USE ISSUE70 reports
WEIGHT DECREASED69 reports
SEPSIS68 reports
GAIT DISTURBANCE67 reports
INFECTION67 reports
PAIN IN EXTREMITY67 reports
PRODUCT USE IN UNAPPROVED INDICATION67 reports
SLEEP DISORDER67 reports
TACHYCARDIA67 reports
CARDIO RESPIRATORY ARREST66 reports
MUSCLE SPASMS66 reports
CHILLS65 reports
DYSPHAGIA65 reports
PRODUCT PACKAGING QUANTITY ISSUE64 reports
BACK PAIN63 reports
DRUG INTERACTION63 reports
EXPOSURE VIA BREAST MILK62 reports
FEELING ABNORMAL62 reports
RHEUMATOID ARTHRITIS62 reports
DRY MOUTH60 reports
PRODUCT PHYSICAL CONSISTENCY ISSUE60 reports
VISUAL IMPAIRMENT60 reports
PARAESTHESIA58 reports
INJURY57 reports
TREMOR57 reports
INFLAMMATION56 reports
IRRITABLE BOWEL SYNDROME56 reports
WEIGHT INCREASED56 reports
CHEST PAIN55 reports
HYPERSENSITIVITY55 reports
TASTE DISORDER55 reports
AMNESIA54 reports
BLEPHAROSPASM54 reports
HYPERHIDROSIS54 reports
INFUSION RELATED REACTION53 reports

Report Outcomes

Out of 7,124 classified reports for BUPRENORPHINE HYDROCHLORIDE:

Serious 74.9%Non-Serious 25.1%

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

Female2,749 (51.0%)
Male2,598 (48.2%)
Unknown48 (0.9%)

Reports by Age

Age 43119 reports
Age 4052 reports
Age 4446 reports
Age 5145 reports
Age 5545 reports
Age 6040 reports
Age 4936 reports
Age 5336 reports
Age 5636 reports
Age 4535 reports
Age 4634 reports
Age 5834 reports
Age 3632 reports
Age 6132 reports
Age 3431 reports
Age 5730 reports
Age 6230 reports
Age 6430 reports
Age 5929 reports
Age 7029 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?

This profile reflects 15,869 FDA FAERS reports that mention BUPRENORPHINE 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?

Frequently reported terms in FAERS include DEPENDENCE, OVERDOSE, DEATH, ILL-DEFINED DISORDER, DRUG INEFFECTIVE, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUPRENORPHINE HYDROCHLORIDE?

Labeling and FAERS entries often list BioDelivery Sciences International Inc in connection with BUPRENORPHINE 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.