Diclofenac is a nonsteroidal anti-inflammatory drug sold in the U.S. under 11 brand and generic names, for juvenile arthritis, rheumatoid arthritis and dysmenorrhea. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Diclofenac Sodium (application ANDA200936). Other diclofenac products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . Apply diclofenac sodium topical gel gently to lesion areas twice daily. to adequately cover each lesion. Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered. Avoid contact of diclofenac sodium topical gel with eyes and mucous membranes. Use the lowest effective dosage for shortest duration consistent with the individual patient treatment goals. (2) Apply to lesion areas twice daily to adequately cover each lesion. (2) Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. (2) The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered. (2) Avoid contact in eyes, nose, or mouth. (2)
The following adverse reactions are discussed in greater detail in other sections of the labeling: Anaphylactic Reactions [see Warnings and Precautions (5.1) ] Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.2) ] Serious Skin Reactions [see Warnings and Precautions (5.3) ] Cardiovascular Thrombotic Events [see Warnings and Precautions (5.4) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Hypertension [see Warnings and Precautions (5.7) ] Heart Failure and Edema [see Warnings and Precautions (5.8) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.9) ] DRESS [see Warnings and Precautions (5.10) ] Hematologic Toxicity [see Warnings and Precautions (5.12) ] Photosensitivity [see Warnings and Precautions (5.15) ] Most common adverse reactions with diclofenac sodium topical gel are application site reactions, including dermatitis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 72/100 | Over-the-counter | Topical | Generic | $0 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| P;75 | 75 mg | brown | round | — |
| R;550 | 50 mg | white | round | — |
| R;551 | 75 mg | white | round | — |
| ING;278 | 100 mg | pink | round | — |
| 75;G;0029 | 75 mg / 200 ug | white | round | — |
| YSP;168 | 75 mg / 200 ug |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Diclofenac sodium topical gel is contraindicated in the following patients: With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions (5.1 , 5.3 , 5.10) and Description (11) ] With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.1 , 5.2) ] Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see Warnings and Precautions (5.3) ] In the setting of coronary bypass graft (CABG) surgery [see Warnings and Precautions (5.4) ] Known hypersensitivity to diclofenac or any components of the drug product. (4 , 11) History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. (4) Use on damaged skin. (4) In the setting of coronary artery bypass graft (CABG) surgery. (4)
See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac sodium topical gel with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.5) ] . Aspirin Clinical Impact: In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.5) ] . Intervention: Concomitant use of diclofenac sodium topical gel and analgesic doses of aspirin is…
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| 3 | 68/100 | Prescription | Tablet | Generic | $0 | View → |
| 4 | 68/100 | Prescription | Tablet | Generic | $0 | View → |
| 5 | 68/100 | Prescription | Tablet | Generic | $0 | View → |
| 6 | Not yet rated | Prescription | Solution | Generic | $0 | View → |
| 7 | Not yet rated | Prescription | Capsule | Generic | $0 | View → |
| 8 | Not yet rated | Prescription | Solution | Generic | $0 | View → |
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| 10 | Not yet rated | Prescription | Capsule | Generic | $0 | View → |
| white |
| round |
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| 0397 | 50 mg / 200 ug | white | round | — |
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| 0398 | 75 mg / 200 ug | white | round | — |
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| YSP;168 | 75 mg / 200 ug | white | round | — |
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| YSP;167 | 50 mg / 200 ug | white | round | — |
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| A;46 | 50 mg | white | round | — |
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| UpArrowheadE11 | 50 mg | white | round | — |
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