BUPRENORPHINE AND NALOXONE

N/A

Manufactured by Amneal Pharmaceuticals LLC

2,589 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BUPRENORPHINE AND NALOXONE

BUPRENORPHINE AND NALOXONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for BUPRENORPHINE AND NALOXONE include NAUSEA, DRUG INEFFECTIVE, VOMITING, INJECTION SITE REACTION, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPRENORPHINE AND NALOXONE.

Top Adverse Reactions

NAUSEA138 reports
DRUG INEFFECTIVE94 reports
VOMITING92 reports
INJECTION SITE REACTION90 reports
HEADACHE79 reports
PRODUCT SUBSTITUTION ISSUE73 reports
WITHDRAWAL SYNDROME70 reports
DRUG ABUSE68 reports
TOXICITY TO VARIOUS AGENTS65 reports
DRUG WITHDRAWAL SYNDROME61 reports
HYPERHIDROSIS52 reports
OFF LABEL USE51 reports
PAIN50 reports
ANXIETY49 reports
CARDIO RESPIRATORY ARREST42 reports
DIZZINESS42 reports
MALAISE42 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS41 reports
DRUG DEPENDENCE40 reports
OVERDOSE36 reports
INSOMNIA34 reports
PRODUCT SOLUBILITY ABNORMAL33 reports
DENTAL CARIES32 reports
DYSPNOEA32 reports
FEELING ABNORMAL32 reports
COMPLETED SUICIDE31 reports
FATIGUE30 reports
SOMNOLENCE30 reports
DEATH28 reports
DIARRHOEA28 reports
INTENTIONAL PRODUCT USE ISSUE27 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION24 reports
TOOTH LOSS24 reports
ASTHENIA22 reports
CHILLS22 reports
PRODUCT QUALITY ISSUE22 reports
DEPRESSION21 reports
DRUG INTERACTION21 reports
DRUG INTOLERANCE20 reports
INCORRECT DOSE ADMINISTERED20 reports
CARDIAC ARREST19 reports
TREMOR19 reports
DRUG USE DISORDER18 reports
PAIN IN EXTREMITY18 reports
RESPIRATORY ARREST18 reports
ABDOMINAL DISCOMFORT17 reports
CONFUSIONAL STATE17 reports
CONSTIPATION17 reports
ILLNESS17 reports
DEPRESSED LEVEL OF CONSCIOUSNESS16 reports
EXPOSURE DURING PREGNANCY16 reports
FOETAL EXPOSURE DURING PREGNANCY16 reports
RHINORRHOEA16 reports
WEIGHT DECREASED16 reports
MUSCLE SPASMS15 reports
RESTLESSNESS15 reports
TOOTH FRACTURE15 reports
ABDOMINAL PAIN UPPER14 reports
PRODUCT DOSE OMISSION ISSUE14 reports
PRURITUS14 reports
STOMATITIS14 reports
BACK PAIN13 reports
FALL13 reports
INTENTIONAL PRODUCT MISUSE13 reports
LOSS OF CONSCIOUSNESS13 reports
RASH13 reports
SUICIDAL IDEATION13 reports
ARTHRALGIA12 reports
DECREASED APPETITE12 reports
DRUG WITHDRAWAL SYNDROME NEONATAL12 reports
GASTROINTESTINAL DISORDER12 reports
HYPERSENSITIVITY12 reports
MATERNAL EXPOSURE DURING PREGNANCY12 reports
PERIPHERAL ISCHAEMIA12 reports
PRODUCT PACKAGING QUANTITY ISSUE12 reports
PYREXIA12 reports
RESTLESS LEGS SYNDROME12 reports
SEROTONIN SYNDROME12 reports
WEIGHT INCREASED12 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD11 reports
CONDITION AGGRAVATED11 reports
DELIRIUM11 reports
HYPERTENSION11 reports
LETHARGY11 reports
PNEUMONIA11 reports
TREATMENT FAILURE11 reports
VISION BLURRED11 reports
ACUTE KIDNEY INJURY10 reports
AGITATION10 reports
DRUG DIVERSION10 reports
DRY MOUTH10 reports
FLUSHING10 reports
FOREIGN BODY EMBOLISM10 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION10 reports
IRRITABILITY10 reports
MENTAL STATUS CHANGES10 reports
MYALGIA10 reports
PRODUCT DISPENSING ERROR10 reports
SEIZURE10 reports
THERAPEUTIC RESPONSE DECREASED10 reports

Report Outcomes

Out of 1,149 classified reports for BUPRENORPHINE AND NALOXONE:

Serious 55.8%Non-Serious 44.2%

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

Female472 (51.3%)
Male446 (48.5%)
Unknown2 (0.2%)

Reports by Age

Age 3434 reports
Age 4027 reports
Age 3124 reports
Age 3523 reports
Age 3622 reports
Age 3021 reports
Age 3921 reports
Age 4121 reports
Age 3319 reports
Age 3719 reports
Age 4919 reports
Age 3216 reports
Age 4816 reports
Age 5416 reports
Age 4415 reports
Age 5715 reports
Age 3813 reports
Age 4213 reports
Age 4713 reports
Age 2912 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 AND NALOXONE?

This profile reflects 2,589 FDA FAERS reports that mention BUPRENORPHINE AND NALOXONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUPRENORPHINE AND NALOXONE?

Frequently reported terms in FAERS include NAUSEA, DRUG INEFFECTIVE, VOMITING, INJECTION SITE REACTION, HEADACHE, PRODUCT SUBSTITUTION ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUPRENORPHINE AND NALOXONE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with BUPRENORPHINE AND NALOXONE. 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.