Two medicines, side by side
Tapentadol vs tramadol
Tapentadol and tramadol are both labeled for pain. Drugs@FDA records approvals of tapentadol since 2008 and of tramadol since 1995. Pharmacies paid $14.48 per tapentadol HCl 100 mg tablet and $0.0248 per tramadol HCl 50 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Tapentadol, “Tapentadol is a centrally-acting synthetic analgesic.”; Tramadol, “Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin.”
Check it at the source: the tapentadol FDA label on DailyMed (effective February 26, 2026); the tramadol FDA label on DailyMed (effective March 5, 2026).
Highlights of the tapentadol record
Tapentadol (Nucynta) · label of February 26, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF tapentadol TABLETS Addiction, Abuse, and Misuse Because the use of tapentadol tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ].
Used for
From the label: indicationsTapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. […]
On the market
- Earliest approval on file
- November 20, 2008
- Generic labelers
- 4 labelers
- Pharmacy cost
- $14.48 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the tramadol record
Tramadol (Ultram) · label of March 5, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of Tramadol hydrochloride extended-release tablet exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )].
Used for
From the label: indicationsTramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. […]
On the market
- Earliest approval on file
- March 3, 1995
- Generic labelers
- 39 labelers
- Pharmacy cost
- $0.0248 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Tapentadol label of February 26, 2026, Tramadol label of March 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do tapentadol and tramadol differ on the record?
How each works, in its label's words: Tapentadol, “Tapentadol is a centrally-acting synthetic analgesic.”; Tramadol, “Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin.”
Both are in FDA's class opioid agonists.
Both labels carry a boxed warning; the records quote them.
Generics: tapentadol since 2026; tramadol since 2002 (Drugs@FDA).
DEA schedule: tapentadol CII; tramadol CIV.
| Tapentadol | Tramadol | |
|---|---|---|
| Labeled for | Pain | Pain |
| Pharmacologic class | Opioid Agonist | Opioid Agonist |
| How it works (label) | Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. | Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin. |
| Half-life (label) | The terminal half-life is on average 4 hours after oral administration. | n/a |
| Earliest approval on file (Drugs@FDA) | November 20, 2008 | March 3, 1995 |
| First generic approved | January 26, 2026 | June 19, 2002 |
| Generic labelers (NDC) | 4 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $14.48 per tablet (Tapentadol HCl 100 mg tablet) | $0.0248 per tablet (Tramadol HCl 50 mg tablet) |
| 12-month price change | n/a | -1% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 33,272 | 37,421 |
| DEA schedule | CII | CIV |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Tramadol label, warnings and precautionsRisks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of tramadol hydrochloride extended-release tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics …
Source: FDA drug labels via openFDA
What next?
- Alternatives to tapentadol
- every medicine labeled for the same conditions