Two medicines, side by side
Diclofenac vs tramadol
Diclofenac and tramadol are both labeled for pain. Drugs@FDA records approvals of diclofenac since 1988 and of tramadol since 1995. Pharmacies paid $0.0619 per diclofenac sod DR 75 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. In FDA's classes, diclofenac is a nonsteroidal anti-inflammatory drug and tramadol an opioid agonist.
Check it at the source: the diclofenac FDA label on DailyMed (effective February 11, 2025); the tramadol FDA label on DailyMed (effective March 5, 2026).
Highlights of the diclofenac record
Diclofenac (Voltaren) · label of February 11, 2025
Used for
From the label: indications• for the temporary relief of arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o foot, ankle, knee (lower body areas) • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
On the market
- Earliest approval on file
- July 28, 1988
- Generic labelers
- 149 labelers
- Pharmacy cost
- $0.0619 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 6
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 (Diclofenac label of February 11, 2025, Tramadol label of March 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do diclofenac and tramadol differ on the record?
In FDA's classes, diclofenac is a nonsteroidal anti-inflammatory drug and tramadol an opioid agonist.
Both labels carry a boxed warning; the records quote them.
Generics: diclofenac since 1995; tramadol since 2002 (Drugs@FDA).
DEA schedule: diclofenac none; tramadol CIV.
| Diclofenac | Tramadol | |
|---|---|---|
| Labeled for | Pain, Osteoarthritis, Rheumatoid arthritis, Migraine | Pain |
| Pharmacologic class | Nonsteroidal Anti-inflammatory Drug | Opioid Agonist |
| How it works (label) | n/a | Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin. |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | July 28, 1988 | March 3, 1995 |
| First generic approved | June 29, 1995 | June 19, 2002 |
| Generic labelers (NDC) | 149 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0619 per tablet (Diclofenac sod DR 75 mg tablet) | $0.0248 per tablet (Tramadol HCl 50 mg tablet) |
| 12-month price change | -25% | -1% |
| Boxed warning | Yes | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 6 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 158,675 | 37,421 |
| DEA schedule | none | 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?
Diclofenac label, drug interactions (prescription label)The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.
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 diclofenac
- every medicine labeled for the same conditions