What the label lists and what reports show
Tapentadol side effects
Tapentadol's FDA label: “The most common adverse reactions were Adults (incidence ≥10%) were nausea, dizziness, vomiting and somnolence.” FAERS holds 33,272 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is toxicity to various agents (9,796 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the tapentadol FDA label on DailyMed (effective February 26, 2026, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions were Adults (incidence ≥10%) were nausea, dizziness, vomiting and somnolence.
Table 1. Adverse Reactions Reported by ≥1% of tapentadol-Treated Patients In Seven Phase 2/3 Placebo- and/or Oxycodone-Controlled, One Non-controlled, and One Phase 3 Oxycodone-Controlled Safety, Multiple-Dose Clinical…
| System/Organ Class MedDRA Preferred Term | tapentadol 21 mg – 120 mg (n = 2178) % | Placebo (n = 619) % |
|---|---|---|
| Nausea | 30 | 13 |
| Vomiting | 18 | 4 |
| Constipation | 8 | 3 |
| Dry mouth | 4 | <1 |
| Dyspepsia | 2 | <1 |
| Fatigue | 3 | <1 |
| Feeling hot | 1 | <1 |
| Nasopharyngitis | 1 | <1 |
| Upper respiratory tract infection | 1 | <1 |
| Urinary tract infection | 1 | <1 |
| Decreased appetite | 2 | 0 |
| Dizziness | 24 | 8 |
| Somnolence | 15 | 3 |
| Tremor | 1 | <1 |
| Lethargy | 1 | <1 |
| Insomnia | 2 | <1 |
| Confusional state | 1 | 0 |
| Abnormal dreams | 1 | <1 |
| Anxiety | 1 | <1 |
| Pruritus | 5 | 1 |
| Hyperhidrosis | 3 | <1 |
| Pruritus generalized | 3 | <1 |
| Rash | 1 | <1 |
| Hot flush | 1 | <1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6) Serotonin Syndrome [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [ see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] The most common adverse reactions were Adults (incidence ≥10%) were nausea, dizziness, vomiting and somnolence. ( 6.1 ) Pediatric patients 6 years and older (incidence ≥5%): vomiting, constipation, nausea, pruritus, and pyrexia To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. …
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective February 26, 2026 (SPL set 863f3fd3-1e8d-41b0-855f-8f9a29237cda), via openFDA; the full label on DailyMed
What do FAERS reports show?
33,272 reports list tapentadol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 20,613 are coded as a death and 4,501 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (21,688, against a median of 706 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 17 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tapentadol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions