NALOXONE HYDROCHLORIDE

N/A

Manufactured by Emergent Devices Inc.

10,081 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Emergent Devices Inc.. The most commonly reported adverse reactions for NALOXONE HYDROCHLORIDE include NAUSEA, FATIGUE, PAIN, DEATH, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NALOXONE HYDROCHLORIDE.

Top Adverse Reactions

NAUSEA348 reports
FATIGUE333 reports
PAIN323 reports
DEATH281 reports
VOMITING269 reports
DIARRHOEA240 reports
DYSPNOEA230 reports
OFF LABEL USE209 reports
TOXICITY TO VARIOUS AGENTS207 reports
DRUG INEFFECTIVE205 reports
OVERDOSE200 reports
FALL192 reports
HEADACHE183 reports
PNEUMONIA161 reports
ANXIETY160 reports
ASTHENIA151 reports
DRUG WITHDRAWAL SYNDROME147 reports
DRUG DEPENDENCE145 reports
DIZZINESS141 reports
ACUTE KIDNEY INJURY135 reports
ARTHRALGIA131 reports
BACK PAIN131 reports
PYREXIA123 reports
MALAISE121 reports
CONSTIPATION120 reports
SOMNOLENCE120 reports
URINARY TRACT INFECTION120 reports
ANAEMIA117 reports
HYPOTENSION116 reports
PRODUCT DOSE OMISSION ISSUE116 reports
WEIGHT DECREASED116 reports
CHRONIC KIDNEY DISEASE113 reports
ABDOMINAL PAIN109 reports
RENAL FAILURE108 reports
DECREASED APPETITE105 reports
PAIN IN EXTREMITY104 reports
CONFUSIONAL STATE103 reports
SEPSIS99 reports
DEPRESSION98 reports
COUGH94 reports
FEELING ABNORMAL92 reports
LOSS OF CONSCIOUSNESS88 reports
INSOMNIA84 reports
HYPERTENSION83 reports
CHEST PAIN82 reports
GAIT DISTURBANCE81 reports
RASH80 reports
EMOTIONAL DISTRESS79 reports
MEMORY IMPAIRMENT76 reports
COVID 1975 reports
HOSPITALISATION75 reports
UNINTENTIONAL USE FOR UNAPPROVED INDICATION72 reports
ILLNESS69 reports
ABDOMINAL PAIN UPPER68 reports
CONDITION AGGRAVATED68 reports
DEHYDRATION67 reports
MUSCLE SPASMS67 reports
PRURITUS66 reports
RESPIRATORY FAILURE66 reports
HYPERHIDROSIS62 reports
DRUG ABUSE61 reports
PERIPHERAL SWELLING61 reports
SEIZURE60 reports
DYSPHAGIA59 reports
INFECTION59 reports
UNRESPONSIVE TO STIMULI59 reports
PRODUCT USE IN UNAPPROVED INDICATION58 reports
PRODUCT USE ISSUE58 reports
CARDIAC ARREST56 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION56 reports
THROMBOCYTOPENIA56 reports
LETHARGY55 reports
MATERNAL EXPOSURE DURING PREGNANCY55 reports
NEUROPATHY PERIPHERAL54 reports
BLOOD PRESSURE INCREASED53 reports
TREMOR53 reports
WEIGHT INCREASED53 reports
WITHDRAWAL SYNDROME53 reports
ATRIAL FIBRILLATION52 reports
CHILLS52 reports
FEBRILE NEUTROPENIA52 reports
HAEMOGLOBIN DECREASED52 reports
ACUTE RESPIRATORY FAILURE51 reports
TACHYCARDIA51 reports
MIGRAINE49 reports
OEDEMA PERIPHERAL48 reports
OXYGEN SATURATION DECREASED48 reports
ABDOMINAL DISCOMFORT47 reports
GENERAL PHYSICAL HEALTH DETERIORATION47 reports
MALIGNANT NEOPLASM PROGRESSION47 reports
PREMATURE DELIVERY47 reports
SWELLING47 reports
HYPOAESTHESIA46 reports
MUSCULAR WEAKNESS45 reports
PULMONARY OEDEMA45 reports
DRUG HYPERSENSITIVITY43 reports
HYPOXIA43 reports
NECK PAIN43 reports
MYALGIA42 reports
INTENTIONAL PRODUCT USE ISSUE41 reports

Report Outcomes

Out of 4,469 classified reports for NALOXONE HYDROCHLORIDE:

Serious 71.5%Non-Serious 28.5%

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

Female2,224 (55.5%)
Male1,781 (44.5%)
Unknown1 (0.0%)

Reports by Age

Age 6480 reports
Age 5573 reports
Age 5872 reports
Age 7070 reports
Age 6669 reports
Age 5467 reports
Age 5766 reports
Age 6565 reports
Age 6965 reports
Age 6763 reports
Age 5362 reports
Age 5258 reports
Age 5658 reports
Age 6157 reports
Age 6357 reports
Age 6854 reports
Age 6052 reports
Age 6252 reports
Age 7252 reports
Age 7452 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 NALOXONE HYDROCHLORIDE?

This profile reflects 10,081 FDA FAERS reports that mention NALOXONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NALOXONE HYDROCHLORIDE?

Frequently reported terms in FAERS include NAUSEA, FATIGUE, PAIN, DEATH, VOMITING, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NALOXONE HYDROCHLORIDE?

Labeling and FAERS entries often list Emergent Devices Inc. in connection with 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.