METHADONE HYDROCHLORIDE

N/A

Manufactured by SpecGx LLC

22,018 FDA adverse event reports analyzed

Last updated: 2026-04-14

About METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SpecGx LLC. The most commonly reported adverse reactions for METHADONE HYDROCHLORIDE include FOETAL EXPOSURE DURING PREGNANCY, DRUG WITHDRAWAL SYNDROME NEONATAL, TOXICITY TO VARIOUS AGENTS, DRUG DEPENDENCE, OVERDOSE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHADONE HYDROCHLORIDE.

Top Adverse Reactions

FOETAL EXPOSURE DURING PREGNANCY1,450 reports
DRUG WITHDRAWAL SYNDROME NEONATAL1,428 reports
TOXICITY TO VARIOUS AGENTS1,093 reports
DRUG DEPENDENCE1,021 reports
OVERDOSE925 reports
DRUG ABUSE771 reports
DEATH571 reports
PAIN545 reports
DEPENDENCE534 reports
MATERNAL EXPOSURE DURING PREGNANCY530 reports
DEVELOPMENTAL DELAY507 reports
LEARNING DISABILITY465 reports
ANXIETY434 reports
EXPOSURE DURING PREGNANCY391 reports
COMPLETED SUICIDE384 reports
EMOTIONAL DISTRESS384 reports
DRUG INTERACTION305 reports
DRUG WITHDRAWAL SYNDROME299 reports
NAUSEA278 reports
SOMNOLENCE278 reports
FATIGUE271 reports
CARDIO RESPIRATORY ARREST252 reports
DRUG INEFFECTIVE244 reports
ELECTROCARDIOGRAM QT PROLONGED236 reports
VOMITING229 reports
SUICIDE ATTEMPT208 reports
ACCIDENTAL OVERDOSE203 reports
PREMATURE BABY197 reports
HEADACHE195 reports
OFF LABEL USE190 reports
CARDIAC ARREST189 reports
COMA189 reports
PNEUMONIA184 reports
PREMATURE DELIVERY179 reports
DYSPNOEA167 reports
DRUG EXPOSURE DURING PREGNANCY165 reports
RESPIRATORY DEPRESSION162 reports
DEPRESSION152 reports
CONSTIPATION149 reports
RESPIRATORY ARREST148 reports
DRUG DIVERSION147 reports
INTENTIONAL PRODUCT MISUSE143 reports
CONFUSIONAL STATE141 reports
DIARRHOEA133 reports
LOSS OF CONSCIOUSNESS132 reports
MIOSIS119 reports
WEIGHT DECREASED117 reports
FALL114 reports
DEPRESSED LEVEL OF CONSCIOUSNESS112 reports
TORSADE DE POINTES112 reports
VISION ABNORMAL NEONATAL112 reports
PREMATURE LABOUR111 reports
BACK PAIN109 reports
MALAISE109 reports
WITHDRAWAL SYNDROME108 reports
HYPOTENSION107 reports
POISONING104 reports
CARDIAC DISORDER102 reports
DIZZINESS102 reports
WEIGHT INCREASED100 reports
AGITATION99 reports
ASTHENIA98 reports
VISUAL IMPAIRMENT95 reports
PULMONARY OEDEMA94 reports
INTENTIONAL OVERDOSE93 reports
PYREXIA91 reports
RHABDOMYOLYSIS89 reports
SUBSTANCE ABUSE89 reports
HYPERHIDROSIS88 reports
HYPERTENSION86 reports
SUICIDAL IDEATION86 reports
SOPOR85 reports
DISABILITY84 reports
DRUG USE DISORDER84 reports
ABDOMINAL PAIN83 reports
INSOMNIA83 reports
PAIN IN EXTREMITY83 reports
DECREASED APPETITE82 reports
DRUG LEVEL INCREASED82 reports
PNEUMONIA ASPIRATION82 reports
ANAEMIA81 reports
CHEST PAIN80 reports
PRODUCT DOSE OMISSION ISSUE80 reports
UNRESPONSIVE TO STIMULI80 reports
ARTHRALGIA77 reports
RESPIRATORY FAILURE74 reports
SUBSTANCE USE DISORDER74 reports
RASH73 reports
TREMOR73 reports
DELIRIUM71 reports
DRUG TOXICITY70 reports
SEIZURE69 reports
TACHYCARDIA69 reports
FEELING ABNORMAL67 reports
HALLUCINATION67 reports
BRADYPNOEA66 reports
HYPOXIA65 reports
MULTIPLE DRUG OVERDOSE64 reports
OEDEMA PERIPHERAL63 reports
PRODUCT USE IN UNAPPROVED INDICATION63 reports

Report Outcomes

Out of 10,502 classified reports for METHADONE HYDROCHLORIDE:

Serious 86.2%Non-Serious 13.8%

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

Male4,154 (50.0%)
Female3,840 (46.2%)
Unknown314 (3.8%)

Reports by Age

Age 1496 reports
Age 26233 reports
Age 31230 reports
Age 43163 reports
Age 39150 reports
Age 55138 reports
Age 44136 reports
Age 47127 reports
Age 45124 reports
Age 46122 reports
Age 52122 reports
Age 48117 reports
Age 32116 reports
Age 34109 reports
Age 37105 reports
Age 49103 reports
Age 33102 reports
Age 41102 reports
Age 51102 reports
Age 54101 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 METHADONE HYDROCHLORIDE?

This profile reflects 22,018 FDA FAERS reports that mention METHADONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for METHADONE HYDROCHLORIDE?

Frequently reported terms in FAERS include FOETAL EXPOSURE DURING PREGNANCY, DRUG WITHDRAWAL SYNDROME NEONATAL, TOXICITY TO VARIOUS AGENTS, DRUG DEPENDENCE, OVERDOSE, DRUG ABUSE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures METHADONE HYDROCHLORIDE?

Labeling and FAERS entries often list SpecGx LLC in connection with METHADONE 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.