Molecule
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. MedsAcross supplies Diclofenac for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZIPSOR is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ZIPSOR is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.
Source: US FDA prescribing information
Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of ZIPSOR, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Source: US FDA prescribing information
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. The dosage is 25 mg four times a day General Dosing Instructions Carefully consider the potential benefits and risks of ZIPSOR and other treatment options before deciding to use ZIPSOR. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. For treatment of mild to moderate acute pain in adult and pediatric patients 12 years of age and older, the dosage is 25 mg four times a day. Dosage Adjustments in Patients with Hepatic Impairment Patients with hepatic disease may require reduced doses of ZIPSOR compared to patients with normal hepatic function. As with other diclofenac products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Source: US FDA prescribing information
ZIPSOR 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 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 In the setting of coronary artery bypass graft (CABG) surgery ZIPSOR contains gelatin and is contraindicated in patients with known hypersensitivity to bovine protein. Known hypersensitivity to diclofenac or any components of the drug product.
Source: US FDA prescribing information
Boxed warning (risk of serious cardiovascular and gastrointestinal events): Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. Heart Failure and Edema: Avoid use of ZIPSOR in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events GI Bleeding, Ulceration and Perforation Hepatotoxicity Hypertension Heart Failure and Edema Renal Toxicity and Hyperkalemia Anaphylactic Reactions Serious Skin Reactions Hematologic Toxicity Most common adverse reactions (incidence ≥ 1%) are gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, dizziness, headache, somnolence, pruritus, and increased sweating
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Storage Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture Dispense in tight container (USP).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
20 presentations of Diclofenac, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Diclofenac 75 mg delayed-release tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 50 mg delayed-release tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 50 mg tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 3% gelTopicalGeneric name | — | US FDA | Available on request |
| Diclofenac 20 mg/g topical solutionTopicalGeneric name | — | US FDA | Available on request |
| Diclofenac 16.05 mg/mL topical solutionTopicalGeneric name | — | US FDA | Available on request |
| Diclofenac 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 100 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 25 mg delayed-release tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 25 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Diclofenac 1% gelTopicalGeneric name | — | US FDA | Available on request |
| Diclofenac 50 mg powder for oral solutionOralGeneric name | — | US FDA | Available on request |
| Diclofenac 1 mg/mL eye dropsOphthalmicGeneric name | — | US FDA | Available on request |
| Diclofenac 1 mg/mL ophthalmic solutionOphthalmicGeneric name | — | US FDA | Available on request |
| Diclofenac 75 mg tabletOralGeneric name | — | US FDA | Available on request |
| Diclofenac 16.05 mg/mL topical solutionTransdermalGeneric name | — | US FDA | Available on request |
| Zipsor 25 mg capsuleOral | Assertio Specialty Pharmaceuticals | US FDA | Available on request |
| Cambia 50 mg powder for oral solutionOral | Assertio Therapeutics | US FDA | Available on request |
| Lofena 25 mg tabletOral | Carwin Pharmaceutical Associates | US FDA | Available on request |
3 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 28 July 1988 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Diclofenac in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 20 presentations of Diclofenac and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Diclofenac, including Cambia, Lofena, Zipsor.
Yes. The US FDA first approved Diclofenac on 28 July 1988, according to Drugs@FDA.
No listed presentation of Diclofenac is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Diclofenac is classified under ATC code D11AX18 (Diclofenac).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.