Hydrocodone bitartrate: adverse event reports filed with FDA

11,473

reports as suspect product

0.1% of all reports · about 510 a year

297

reports, 12 months to June 2026

170 in the 12 months before

87.6%

marked serious by the reporter

91.7% across the class

16.4%

record death among outcomes, as reported

1,876 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 Hydrocodone bitartrate reports recording the termmedian drug in opioid agonist

1. Drug dependencedependence on a medicine69.1%7,928
2. Painpain, site not specified39.5%4,531
3. Emotional distressemotional distress37.8%4,340
4. Drug withdrawal syndromesymptoms on stopping a medicine34.1%3,911
5. Overdosea dose above the recommended amount25.9%2,966
6. Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.8%778
7. Drug withdrawal syndrome neonatal6.7%767
8. Drug abusemisuse of a medicine6.4%739
9. Anxietyanxiety6%691
10. Developmental delayslower development in a child5.2%595
11. Toxicity to various agentspoisoning or toxic effect of one or more substances4.7%538
12. Learning disability4.7%536
13. Deaththe patient died; cause not stated by this term4.3%489
14. Depressionlow mood4%458
15. Mental disorder3.4%395
16. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.3%377
17. Drug diversion3.3%373
18. Completed suicidedeath by suicide2.8%322
19. Unevaluable eventthe event could not be assessed2.5%289
20. Drug hypersensitivityan allergic-type reaction to a medicine2.4%279
21. Disability2.1%243
22. Withdrawal syndrome2%227
23. Drug ineffectivethe medicine did not work as expected1.7%199
24. Nauseafeeling sick1.7%199
25. Cardiac disorder1.7%194
26. Road traffic accidenta road accident1.6%179
27. Insomniadifficulty sleeping1.5%167
28. Injurya physical injury1.4%158
29. Vomitingbeing sick1.4%158
30. Constipationconstipation1.4%155

Top 30 of 798 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. 98.1% 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 11,473 reports.

Drugs most often listed in the same reports

Other products listed in reports where Hydrocodone bitartrate 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 Hydrocodone bitartrate as a suspect or interacting product; reports listing it only as a concomitant medication (5,767) 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.