OpenClaim

Methadone Side Effects

The most commonly reported side effects of methadone include drug dependence, toxicity to various agents, and drug abuse, based on 55,691 FDA adverse event reports from 2004 to 2025. 3.1% of reports found the drug to be ineffective.

Methadone side effects

Percentages show how often each reaction appears relative to total reports for methadone.

1
Drug Dependence10.9%6,091
2
Toxicity To Various Agents9.8%5,452
3
Drug Abuse9.7%5,376
4
Overdose7.0%3,923
5
Pain6.8%3,796
6
Death6.4%3,576
7
Emotional Distress4.5%2,507
8
Drug Withdrawal Syndrome4.4%2,456
9
Foetal Exposure During Pregnancy3.9%2,193
10
Drug Withdrawal Syndrome Neonatal3.3%1,814
11
Drug Ineffective3.1%1,725
12
Nausea2.9%1,611
13
Drug Interaction2.8%1,543
14
Fatigue2.5%1,404
15
Anxiety2.5%1,401

These are voluntary reports and do not establish that methadone caused these reactions.

Report severity

86.7%Serious48,268 reports
25.8%Hospitalizations14,371 reports
33.3%Fatal18,540 reports

Seriousness is determined by the reporter, not by OpenClaim.

Methadone drug interactions

Other drugs that appear in adverse event reports alongside methadone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Oxycodone17.8%9,933
2
Acetaminophen13.1%7,284
3
Hydrocodone9.0%4,991
4
Diazepam8.2%4,553
5
Hydromorphone-hydrochloride7.9%4,391
6
Morphine-sulfate7.9%4,379
7
Fentanyl7.8%4,345
8
Buprenorphine6.8%3,811
9
Alprazolam6.6%3,699
10
Tramadol-hydrochloride6.5%3,613
11
Pregabalin5.1%2,816
12
Cocaine-hydrochloride4.7%2,628
13
Apomorphine-hydrochloride4.0%2,227
14
Gabapentin3.7%2,087
15
Quetiapine-fumarate3.7%2,080

Taken alongside

1
Acetaminophen7.5%4,185
2
Gabapentin6.7%3,742
3
Oxycodone6.5%3,605
4
Omeprazole4.1%2,256
5
Furosemide4.0%2,245
6
Albuterol4.0%2,221
7
Levothyroxine-sodium3.8%2,093
8
Aspirin3.7%2,038
9
Pregabalin3.6%2,031
10
Ondansetron3.6%2,027
11
Hydromorphone-hydrochloride3.4%1,920
12
Lorazepam3.4%1,900
13
Ergocalciferol3.2%1,802
14
Alprazolam3.2%1,774
15
Diazepam3.1%1,703

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports methadone side effects

38.9% of methadone adverse event reports involve female patients and 47.7% involve male patients. The largest age group is adult at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female38.9%
Male47.7%
Unknown13.5%

Age group

< 26.5%
2–111.9%
12–171.6%
18–6480.6%
65+9.4%

What is methadone used for

Conditions and purposes for which patients were taking methadone when the adverse event was reported.

Abdominal PainAbdominal Pain UpperAbnormal BehaviourAbstains From Recreational DrugsAcarodermatitisAccidentAccident At WorkAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAccidental PoisoningAcquired Epidermolysis BullosaAcute Lymphocytic Leukaemia

Showing 15 of 730 indications

Methadone brand names and reporting trend

Methadone is sold under the brand name Methadone Hydrochloride Intensol.

Brand names

Methadone Hydrochloride Intensol84

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking methadone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.