BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

N/A

Manufactured by Accord Healthcare, Inc

116 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare, Inc. The most commonly reported adverse reactions for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE include TOXICITY TO VARIOUS AGENTS, ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD, DRUG ABUSE, DRUG WITHDRAWAL SYNDROME, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE.

Top Adverse Reactions

TOXICITY TO VARIOUS AGENTS7 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD5 reports
DRUG ABUSE5 reports
DRUG WITHDRAWAL SYNDROME5 reports
NAUSEA4 reports
DIARRHOEA3 reports
LETHARGY3 reports
MALAISE3 reports
VOMITING3 reports
ANXIETY2 reports
DRUG DEPENDENCE2 reports
DRUG INEFFECTIVE2 reports
DRUG INTERACTION2 reports
DRUG SCREEN POSITIVE2 reports
DYSPNOEA2 reports
HYPERHIDROSIS2 reports
HYPERSOMNIA2 reports
SOMNOLENCE2 reports
TREMOR2 reports
UNRESPONSIVE TO STIMULI2 reports
ACCIDENTAL EXPOSURE TO PRODUCT1 reports
ACCIDENTAL OVERDOSE1 reports
ACUTE KIDNEY INJURY1 reports
AKATHISIA1 reports
CARDIAC ARREST1 reports
CEREBRAL ATROPHY1 reports
CHILLS1 reports
COMPLETED SUICIDE1 reports
DELIRIUM1 reports
DRUG WITHDRAWAL SYNDROME NEONATAL1 reports
DRY MOUTH1 reports
DYSTONIA1 reports
ENCEPHALOMALACIA1 reports
ERYTHEMA1 reports
EUPHORIC MOOD1 reports
EXPOSURE VIA INGESTION1 reports
FALL1 reports
FEELING ABNORMAL1 reports
FLUSHING1 reports
FOETAL EXPOSURE DURING PREGNANCY1 reports
GRUNTING1 reports
HALLUCINATION1 reports
HALLUCINATIONS, MIXED1 reports
HEADACHE1 reports
HYPERTONIA1 reports
HYPOAESTHESIA ORAL1 reports
HYPOKINESIA1 reports
HYPOTENSION1 reports
INCORRECT DOSE ADMINISTERED1 reports
INCORRECT PRODUCT ADMINISTRATION DURATION1 reports
INSOMNIA1 reports
INTENTIONAL PRODUCT MISUSE1 reports
IRRITABILITY1 reports
LACUNAR INFARCTION1 reports
MENTAL STATUS CHANGES1 reports
MIOSIS1 reports
OESOPHAGEAL RUPTURE1 reports
OFF LABEL USE1 reports
OVERDOSE1 reports
PAIN1 reports
PNEUMOMEDIASTINUM1 reports
PRURITUS1 reports
PRURITUS GENERALISED1 reports
PULMONARY OEDEMA1 reports
PUPILLARY DISORDER1 reports
RESPIRATORY ARREST1 reports
RESPIRATORY DEPRESSION1 reports
RESTLESS LEGS SYNDROME1 reports
RHABDOMYOLYSIS1 reports
SEIZURE1 reports
SLEEP APNOEA SYNDROME1 reports
SUICIDAL IDEATION1 reports
TACHYCARDIA1 reports
UNDERDOSE1 reports
WITHDRAWAL HYPERTENSION1 reports
WITHDRAWAL SYNDROME1 reports

Report Outcomes

Out of 27 classified reports for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE:

Serious 81.5%Non-Serious 18.5%

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

Female13 (52.0%)
Male12 (48.0%)

Reports by Age

Age 12 reports
Age 212 reports
Age 232 reports
Age 312 reports
Age 652 reports
Age 51 reports
Age 171 reports
Age 191 reports
Age 221 reports
Age 241 reports
Age 421 reports
Age 441 reports
Age 471 reports
Age 521 reports
Age 601 reports
Age 621 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 AND NALOXONE HYDROCHLORIDE DIHYDRATE?

This profile reflects 116 FDA FAERS reports that mention BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

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

Frequently reported terms in FAERS include TOXICITY TO VARIOUS AGENTS, ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD, DRUG ABUSE, DRUG WITHDRAWAL SYNDROME, NAUSEA, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE?

Labeling and FAERS entries often list Accord Healthcare, Inc in connection with BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE. 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.