Two medicines, side by side

Tramadol vs ibuprofen

Tramadol and ibuprofen are both labeled for pain. Drugs@FDA records approvals of tramadol since 1995 and of ibuprofen since 1974. Pharmacies paid $0.0248 per tramadol HCl 50 mg tablet and $0.0573 per ibuprofen 800 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, tramadol is an opioid agonist and ibuprofen a nonsteroidal anti-inflammatory drug.

Check it at the source: the tramadol FDA label on DailyMed (effective March 5, 2026); the ibuprofen FDA label on DailyMed (effective January 1, 2026).

Highlights of the tramadol record

Tramadol (Ultram) · label of March 5, 2026

Boxed warning

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: indications
Tramadol 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

Highlights of the ibuprofen record

Ibuprofen (Advil) · label of January 1, 2026

Used for

From the label: indications
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever

On the market

Earliest approval on file: September 19, 1974
Generic labelers: 245 labelers
Pharmacy cost: $0.0573 per tablet

Supply and safety

Shortage: No current entry
Recalls: 40

Source: FDA drug labels via openFDA (Tramadol label of March 5, 2026, Ibuprofen label of January 1, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do tramadol and ibuprofen differ on the record?

In FDA's classes, tramadol is an opioid agonist and ibuprofen a nonsteroidal anti-inflammatory drug.

Both labels carry a boxed warning; the records quote them.

Generics: tramadol since 2002; ibuprofen since 1985 (Drugs@FDA).

DEA schedule: tramadol CIV; ibuprofen none.

	Tramadol	Ibuprofen
Labeled for	Pain	Fever, Osteoarthritis, Rheumatoid arthritis, Pain, Cough and cold
Pharmacologic class	Opioid Agonist	Nonsteroidal Anti-inflammatory Drug
How it works (label)	Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin.	n/a
Half-life (label)	n/a	n/a
Earliest approval on file (Drugs@FDA)	March 3, 1995	September 19, 1974
First generic approved	June 19, 2002	February 8, 1985
Generic labelers (NDC)	39 labelers	245 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)	$0.0248 per tablet (Tramadol HCl 50 mg tablet)	$0.0573 per tablet (Ibuprofen 800 mg tablet)
12-month price change	-1%	-2%
Boxed warning	Yes	Yes
Shortage now	No current entry	No current entry
Recalls recorded	8	40
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)	37,421	270,516
DEA schedule	CIV	none

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 precautions
Risks 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 …

Ibuprofen label, drug interactions (prescription label)
The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.

Source: FDA drug labels via openFDA

What next?

Tramadol: the full record
Ibuprofen: the full record
Alternatives to tramadol: every medicine labeled for the same conditions