Tapentadol hydrochloride: adverse event reports filed with FDA

827

reports as suspect product

0% of all reports · about 47 a year

11

reports, 12 months to June 2026

58 in the 12 months before

97.2%

marked serious by the reporter

91.7% across the class

22.4%

record death among outcomes, as reported

185 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 Tapentadol hydrochloride reports recording the termmedian drug in opioid agonist

1. Deliriumsudden confusion7.6%63
2. Toxicity to various agentspoisoning or toxic effect of one or more substances7%58
3. Nauseafeeling sick6.8%56
4. Somnolencedrowsiness6.8%56
5. Constipationconstipation5.8%48
6. Confusional stateconfusion5.6%46
7. Malignant neoplasm progression5.6%46
8. Drug ineffectivethe medicine did not work as expected5.4%45
9. Drug interactionan interaction between medicines5.2%43
10. Drug abusemisuse of a medicine4.6%38
11. Overdosea dose above the recommended amount4.6%38
12. Adverse eventan unwanted medical event, type not specified3.9%32
13. Deaththe patient died; cause not stated by this term3.5%29
14. Dizzinesslight-headedness or unsteadiness3.1%26
15. Vomitingbeing sick2.9%24
16. Falla fall2.8%23
17. Malaisegeneral feeling of being unwell2.8%23
18. Decreased appetitereduced appetite2.5%21
19. Dyspnoeashortness of breath2.5%21
20. Painpain, site not specified2.5%21
21. Completed suicidedeath by suicide2.3%19
22. Hallucinationseeing or hearing things that are not there2.3%19
23. Suicide attempta suicide attempt2.2%18
24. Urinary retentionbeing unable to empty the bladder2.2%18
25. Anxietyanxiety2.1%17
26. Fatiguetiredness2.1%17
27. Headachehead pain1.9%16
28. Insomniadifficulty sleeping1.9%16
29. Intentional overdosea deliberate overdose1.9%16
30. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor1.9%16

Top 30 of 211 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. 15.5% 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 827 reports.

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 Tapentadol hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (266) 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.