NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE

N/A

Manufactured by Nalpropion Pharmaceuticals LLC

20,475 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Nalpropion Pharmaceuticals LLC. The most commonly reported adverse reactions for NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE include NAUSEA, HEADACHE, DIZZINESS, VOMITING, CONSTIPATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA1,976 reports
HEADACHE1,108 reports
DIZZINESS1,041 reports
VOMITING671 reports
CONSTIPATION643 reports
FEELING ABNORMAL582 reports
FATIGUE517 reports
ANXIETY404 reports
INSOMNIA392 reports
DIARRHOEA372 reports
DRUG INEFFECTIVE362 reports
PATIENT DISSATISFACTION WITH TREATMENT344 reports
DRUG TITRATION ERROR333 reports
ILLNESS332 reports
TREMOR328 reports
BLOOD PRESSURE INCREASED324 reports
DRY MOUTH294 reports
MALAISE279 reports
WEIGHT INCREASED279 reports
ABDOMINAL PAIN UPPER265 reports
INTENTIONAL PRODUCT USE ISSUE254 reports
URTICARIA251 reports
PALPITATIONS235 reports
CONTRAINDICATED PRODUCT ADMINISTERED219 reports
SOMNOLENCE218 reports
HYPERHIDROSIS216 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE210 reports
FOOD CRAVING205 reports
RASH203 reports
DYSPNOEA193 reports
ABDOMINAL DISCOMFORT192 reports
THERAPY CESSATION182 reports
MIGRAINE181 reports
THERAPY INTERRUPTED171 reports
DEPRESSION170 reports
PRURITUS165 reports
PRODUCT PRESCRIBING ERROR163 reports
HUNGER155 reports
HOT FLUSH154 reports
ABDOMINAL PAIN151 reports
CONDITION AGGRAVATED149 reports
PRODUCT USE ISSUE147 reports
HEART RATE INCREASED144 reports
ASTHENIA141 reports
THERAPEUTIC RESPONSE UNEXPECTED138 reports
ALOPECIA135 reports
PRODUCT DOSE OMISSION ISSUE132 reports
FEELING JITTERY127 reports
PAIN127 reports
ARTHRALGIA125 reports
FALL122 reports
SUICIDAL IDEATION117 reports
VISION BLURRED113 reports
CHEST PAIN111 reports
TINNITUS111 reports
SEIZURE109 reports
BACK PAIN108 reports
DRUG INTOLERANCE106 reports
HYPERTENSION105 reports
OFF LABEL USE105 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION101 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION98 reports
STRESS96 reports
NERVOUSNESS95 reports
ILL DEFINED DISORDER93 reports
AGITATION92 reports
ABDOMINAL DISTENSION91 reports
DISTURBANCE IN ATTENTION91 reports
INABILITY TO AFFORD MEDICATION91 reports
IRRITABILITY91 reports
PANIC ATTACK91 reports
COVID 1990 reports
DRUG INTERACTION88 reports
DYSPEPSIA88 reports
LABELLED DRUG DRUG INTERACTION ISSUE88 reports
FEELING HOT86 reports
MUSCLE SPASMS83 reports
PARAESTHESIA83 reports
DECREASED APPETITE82 reports
ABNORMAL DREAMS81 reports
CHEST DISCOMFORT81 reports
PRODUCT DOSE OMISSION IN ERROR81 reports
PAIN IN EXTREMITY80 reports
DYSGEUSIA78 reports
NONSPECIFIC REACTION78 reports
DEHYDRATION77 reports
TASTE DISORDER77 reports
DEPRESSED MOOD76 reports
SLEEP DISORDER74 reports
HYPERSENSITIVITY72 reports
VERTIGO72 reports
DRUG HYPERSENSITIVITY71 reports
HYPOAESTHESIA71 reports
NO ADVERSE EVENT71 reports
FLATULENCE69 reports
HALLUCINATION69 reports
MEMORY IMPAIRMENT69 reports
PERIPHERAL SWELLING69 reports
THERAPEUTIC PRODUCT EFFECT DECREASED68 reports
NASOPHARYNGITIS67 reports

Report Outcomes

Out of 8,414 classified reports for NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE:

Serious 33.0%Non-Serious 67.0%

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

Female6,240 (88.5%)
Male792 (11.2%)
Unknown20 (0.3%)

Reports by Age

Age 49115 reports
Age 52112 reports
Age 53109 reports
Age 45106 reports
Age 57105 reports
Age 40100 reports
Age 54100 reports
Age 5699 reports
Age 4696 reports
Age 4796 reports
Age 6092 reports
Age 5591 reports
Age 4890 reports
Age 5087 reports
Age 6185 reports
Age 5184 reports
Age 3882 reports
Age 5882 reports
Age 4381 reports
Age 3979 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 NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE?

This profile reflects 20,475 FDA FAERS reports that mention NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE?

Frequently reported terms in FAERS include NAUSEA, HEADACHE, DIZZINESS, VOMITING, CONSTIPATION, FEELING ABNORMAL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE?

Labeling and FAERS entries often list Nalpropion Pharmaceuticals LLC in connection with NALTREXONE HYDROCHLORIDE AND BUPROPION 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.