Methadose: adverse event reports filed with FDA

3,672

reports as suspect product

0% of all reports · about 164 a year

29

reports, 12 months to June 2026

29 in the 12 months before

93.2%

marked serious by the reporter

91.7% across the class

29.8%

record death among outcomes, as reported

1,094 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Methadose reports recording the termmedian drug in opioid agonist

1. Drug withdrawal syndrome neonatal32.4%1,188
2. Foetal exposure during pregnancythe unborn baby was exposed to the medicine30.6%1,122
3. Drug dependencedependence on a medicine16.5%605
4. Maternal exposure during pregnancythe mother took the medicine during pregnancy11.5%422
5. Developmental delayslower development in a child10.3%380
6. Learning disability9.3%340
7. Completed suicidedeath by suicide8.1%297
8. Painpain, site not specified6.9%254
9. Emotional distressemotional distress6.4%236
10. Anxietyanxiety6.2%227
11. Overdosea dose above the recommended amount5.8%212
12. Cardio-respiratory arrestthe heart and breathing stopped5.4%197
13. Premature babya baby born early4.7%172
14. Premature delivery4.6%169
15. Deaththe patient died; cause not stated by this term4.3%158
16. Drug exposure during pregnancythe medicine was taken during pregnancy4.2%156
17. Drug abusemisuse of a medicine4.2%155
18. Drug withdrawal syndromesymptoms on stopping a medicine4%147
19. Suicide attempta suicide attempt3.6%132
20. Premature labour3%111
21. Toxicity to various agentspoisoning or toxic effect of one or more substances2.7%98
22. Vision abnormal neonatal2%74
23. Cardiac arrestthe heart stopped1.8%66
24. Respiratory arrestbreathing stopped1.7%62
25. Visual impairmentreduced vision1.7%62
26. Multiple drug overdose1.7%61
27. Accidental overdosean accidental overdose1.6%60
28. Cardiac disorder1.6%60
29. Disability1.5%54
30. Drug toxicity1.3%46

Top 30 of 335 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 42 drugs in the opioid agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 965,051 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 61.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,672 reports.

Drugs most often listed in the same reports

Other products listed in reports where Methadose is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the opioid agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Methadose as a suspect or interacting product; reports listing it only as a concomitant medication (113) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.