Diclofenac Epolamine: uses, dosing, side effects & brands
Diclofenac Epolamine is a nonsteroidal anti-inflammatory drug sold in the U.S. under 2 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.
Key facts
- Drug class
- Nonsteroidal Anti-Inflammatory Drug
- Treats
- Juvenile Arthritis, Rheumatoid Arthritis and Dysmenorrhea
- Available as
- System
- Sold as
- 2 products — Flector and Licart
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Half-life
- about 2 hours (terminal/elimination half-life; the label's table gives a mean of 2.3 hours in healthy adults, with wide variation between people — 48% coefficient of variation)
- What the pharmacy pays
- about $146 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How diclofenac epolamine is dosed
From the FDA label for Flector (application NDA021234). Other diclofenac epolamine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest effective dosage for shortest duration consist with the individual patient treatment goals ( 2.1 ) The recommended dose of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% for adults and pediatric patients 6 years and older is one (1) topical system to the most painful area twice a day. ( 2 ) DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% should not be applied to damaged or non-intact skin. ( 2 ) 2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. The recommended dose of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is one (1) topical system to the most painful area twice a day both in adults and pediatric patients 6 years of age and older. 2.2 Special Precautions Inform patients that, if DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% begins to peel-off, the edges of the topical system may be taped down. If problems with adhesion persist, patients may overlay the topical system with a mesh netting sleeve, where appropriate (e.g. to secure topical systems applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad ® Hold Tite™, Surgilast ® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% to non-intact or damaged skin resulting from any etiology e.g.…
Diclofenac Epolamine side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2) ] Hepatotoxicity [ see Warnings and Precautions (5.3) ] Hypertension [ see Warnings and Precautions (5.4) ] Heart Failure and Edema [ see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ] Anaphylactic Reactions [ see Warnings and Precautions (5.7) ] Serious Skin Reactions [ see Warnings and Precautions (5.9) ] Hematologic Toxicity [ see Warnings and Precautions (5.12) ] The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM and placebo-treated adult patients were pruritus (5% and 8%, respectively) and nausea (3% and 2%, respectively) ( 6.1 ). The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treated pediatric patients were headache (9%) and application site pruritus (7%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 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 with rates in the…
Who shouldn’t take diclofenac epolamine
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see Warnings and Precautions (5.7 , 5.9 ) ] 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 (5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions (5.1) ] DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. Known hypersensitivity to diclofenac or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 ) For use on non-intact or damaged skin ( 4 )
Diclofenac Epolamine drug interactions
See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac 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 EPOLAMINE TOPICAL SYSTEM 1.3% 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 (5.12) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. 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 (5.2) ]. Intervention: Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions (5.12) ]. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see Warnings and Precautions (5.6) ] . When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Warnings and Precautions (5.6) ]. Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance . The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and lithium, monitor patients for signs of lithium toxicity. Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine Clinical Impact: Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and cyclosporine may increase cyclosporine's nephrotoxicity. Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates Clinical Impact: Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions (5.2) ] . Intervention: The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended. Pemetrexed Clinical Impact: Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). Intervention: During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly using DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% with drugs that interfere with hemostasis. Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and analgesic doses of aspirin is not generally recommended ( 7 ) ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% may diminish the antihypertensive effect of these drugs. Monitor blood pressure ( 7 ) ACE Inhibitors and ARBs : Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function ( 7 ) Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects ( 7 ) Digoxin : Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% may increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels ( 7 )
Every diclofenac epolamine product we track (2)
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? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | System | Generic | $146 | View → | |
| 2 | Not yet rated | Prescription | System | Generic | $146 | View → |
How long diclofenac epolamine keeps
No diclofenac epolamine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does diclofenac epolamine expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about diclofenac epolamine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 705 reports naming diclofenac epolamine, and the FDA flagged 41% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- drug hypersensitivity185 reports
- fatigue36 reports
- dyspnoea32 reports
- malaise32 reports
- congenital anomaly30 reports
- headache29 reports
- diarrhoea28 reports
- nasopharyngitis27 reports
Read these as a signal, not a rate. A report does not mean diclofenac epolamine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
How long diclofenac epolamine stays in your system
The elimination half-life of diclofenac epolamine is about 2 hours (terminal/elimination half-life; the label's table gives a mean of 2.3 hours in healthy adults, with wide variation between people — 48% coefficient of variation). This is the terminal (elimination) half-life of unchanged diclofenac, as the label labels it — "Terminal Half-life (hr) 2.3" in the PK table, and in the text "the terminal half-life of unchanged diclofenac is approximately 2 hours." Diclofenac is not a prodrug, and it has no active metabolite that outlasts it: the label names five metabolites and says the major one, 4'-hydroxy-diclofenac, has "very weak pharmacologic activity," so the parent's ~2-hour half-life is what governs. (The related diclofenac/misoprostol label notes one additional urinary metabolite with an 80-hour half-life, but it accounts for only ~1.4% of the dose.) Populations the label names: kidney impairment — no dose adjustment for mild-to-moderate impairment; in subjects with inulin clearance 60-90, 30-60 and <30 mL/min, AUC and elimination rate were comparable to healthy subjects. Liver impairment — hepatic metabolism accounts for almost 100% of diclofenac elimination, so patients with liver disease may need reduced doses; the label does not give a revised half-life number. This label reports no pharmacokinetic study in older adults or in children; the diclofenac/misoprostol label found no PK differences in subjects aged 66-81 versus younger adults. Half-life describes how the drug leaves plasma. It is not a detection window (metabolites are detectable far longer) and not dosing guidance.
DailyMed — DICLOFENAC SODIUM tablet, delayed release (FDA label, Clinical Pharmacology / Pharmacokinetics) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is diclofenac epolamine?
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug, available for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.
What kind of drug is diclofenac epolamine?
The FDA classifies diclofenac epolamine as a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does diclofenac epolamine stay in your system?
The elimination half-life of diclofenac epolamine is about 2 hours (terminal/elimination half-life; the label's table gives a mean of 2.3 hours in healthy adults, with wide variation between people — 48% coefficient of variation) — that is how long the body takes to clear half of a dose. This is the terminal (elimination) half-life of unchanged diclofenac, as the label labels it — "Terminal Half-life (hr) 2.3" in the PK table, and in the text "the terminal half-life of unchanged diclofenac is approximately 2 hours." Diclofenac is not a prodrug, and it has no active metabolite that outlasts it: the label names five metabolites and says the major one, 4'-hydroxy-diclofenac, has "very weak pharmacologic activity," so the parent's ~2-hour half-life is what governs. (The related diclofenac/misoprostol label notes one additional urinary metabolite with an 80-hour half-life, but it accounts for only ~1.4% of the dose.) Populations the label names: kidney impairment — no dose adjustment for mild-to-moderate impairment; in subjects with inulin clearance 60-90, 30-60 and <30 mL/min, AUC and elimination rate were comparable to healthy subjects. Liver impairment — hepatic metabolism accounts for almost 100% of diclofenac elimination, so patients with liver disease may need reduced doses; the label does not give a revised half-life number. This label reports no pharmacokinetic study in older adults or in children; the diclofenac/misoprostol label found no PK differences in subjects aged 66-81 versus younger adults. Half-life describes how the drug leaves plasma. It is not a detection window (metabolites are detectable far longer) and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take diclofenac epolamine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run diclofenac epolamine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is diclofenac epolamine sold under?
We track 2 diclofenac epolamine-containing products in the U.S.: Flector and Licart. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does diclofenac epolamine come in?
Across the brands we track, diclofenac epolamine is currently marketed as system, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic diclofenac epolamine?
We do not currently list a generic-labelled diclofenac epolamine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Diclofenac Epolamine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/diclofenac-epolamine
- MLA
- “Diclofenac Epolamine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/diclofenac-epolamine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for diclofenac epolamine on DailyMed (NIH) ↗ — including its boxed warning in full.