Prescription and over-the-counter medicine
Diclofenac Brand names: Voltaren, Zipsor, Cambia, Licart, Flector
Diclofenac (Voltaren) is a prescription and over-the-counter medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 149 generic labelers, and pharmacies paid $0.0619 per diclofenac sod DR 75 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the diclofenac FDA label on DailyMed (effective February 11, 2025, Haleon US Holdings LLC); the NDA 19201 record on Drugs@FDA; every diclofenac label on DailyMed.
Highlights of the record
FDA label of February 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CARDIOVASCULAR AND GASTROINTESTINAL RISK.
Cardiovascular Risk
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].
Diclofenac sodium topical gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)]. Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)]. WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK See full prescribing information for complete boxed warning. Cardiovascular Risk
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. […]
This box is printed on the prescription label of diclofenac; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usagefor 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;
Forms and strengths
- 0.013 g
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 0.01 g/g
- 1 mg/ml
- 1 g/100g
- 1 mg/g
- 1 mg/100g
- 9.3 mg/g
- 10 mg/g
Gel; delayed-release tablet; solution; film-coated tablet; system.
On the market
- Earliest approval on file
- July 28, 1988 Voltaren, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 76 first June 29, 1995; 56 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 158 of which 149 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- February 20, 2035 Licart system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0619 per tablet Diclofenac sod DR 75 mg tablet
- Shortage (FDA)
- None current 6 past records
- Recalls by its makers (FDA)
- 6 since 2012 0 Class I among all firms' recalls; latest January 27, 2026
- FAERS reports
- 158,675 through July 30, 2026
What is diclofenac used for?
From the label: indications and usagefor 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.
Conditions named in the indications of diclofenac's FDA labels, with every medicine labeled for each:
From other diclofenac labelsOsteoarthritis and Rheumatoid arthritis: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Migraine: Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Voltaren Arthritis Pain), Haleon US Holdings LLC, effective February 11, 2025 (SPL set 30a94282-0892-442a-aa10-6525cbd4fe88), via openFDA; the full label on DailyMed
What does the patient leaflet for diclofenac say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed
Source: FDA drug label (Diclofenac Sodium), Proficient Rx LP, effective November 1, 2019 (SPL set a7447467-79e0-436e-a273-d1ddd06169cf), via openFDA; the full label on DailyMed
Is there a generic for diclofenac (Voltaren)?
The FDA approved the first generic diclofenac on June 29, 1995. 76 generic applications are approved; 56 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists diclofenac from 149 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Voltaren Arthritis Pain gel; a patent listed only for Licart system runs to February 20, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1988 earliest approval on file
- 1995 first generic approved
- 2035 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for diclofenac (Voltaren)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0619 per Diclofenac sod DR 75 mg tablet, down 25% from $0.0821 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Diclofenac sod DR 75 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Arthritis pain reliever 1% gel | Generic | $0.0813 per gram | n/a | -9% |
| Diclofenac 0.1% eye drops | Generic | $1.70 per mL | n/a | -9% |
| Diclofenac 1.5% topical solution | Generic | $0.129 per mL | n/a | -28% |
| Diclofenac 2% solution pump | Generic | $0.430 per gram | n/a | -25% |
| Diclofenac epolamine 1.3% ptch | Generic | $4.71 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -7% |
| Diclofenac pot 25 mg tablet | Generic | $4.57 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $137.00 | -58% |
| Diclofenac pot 50 mg powdr packet | Generic | $10.97 per packet many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -25% |
| Diclofenac pot 50 mg tablet | Generic | $0.112 per tablet | $3.37 | -16% |
| Diclofenac potassium 25 mg capsule | Generic | $2.81 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $84.21 | +23% |
| Diclofenac sod DR 25 mg tablet | Generic | $0.684 per tablet | $20.53 | -5% |
| Diclofenac sod DR 50 mg tablet | Generic | $0.0623 per tablet | $1.87 | -32% |
| Diclofenac sod DR 75 mg tablet | Generic | $0.0619 per tablet | $1.86 | -25% |
| Diclofenac sod ec 25 mg tablet | Generic | $0.684 per tablet | $20.53 | -5% |
| Diclofenac sod ec 50 mg tablet | Generic | $0.0623 per tablet | $1.87 | -32% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is diclofenac in shortage?
No diclofenac presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 6 records are all marked to be discontinued, the latest updated August 13, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-06) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | August 13, 2026 |
| Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-11) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | August 13, 2026 |
| Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-96) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | August 13, 2026 |
| Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-06) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | August 13, 2026 |
| Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-11) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | August 13, 2026 |
| Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-96) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | August 13, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has diclofenac been recalled?
The FDA's Enforcement Report lists 6 recalls naming diclofenac since 2012: 0 Class I (the most serious), 5 Class II, 1 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 27, 2026 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. |
| December 22, 2025 | Class III | Cipla USA, Inc. | Failed PH Specifications |
| June 22, 2023 | Class II | ALEMBIC PHARMACEUTICALS, INC. | Defective Delivery System |
| July 2, 2019 | Class II | Altaire Pharmaceuticals, Inc. | Lack of Assurance of Sterility |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the diclofenac label say about other medicines?
The diclofenac label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name diclofenac. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Exercise caution when prescribing LICART with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, antibiotics, anti-epileptics). |
| Aspirin | contraindications (prescription label) | Diclofenac sodium topical gel should not be administered in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Cyclosporine | drug interactions (prescription label) | Cyclosporine Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of diclofenac with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy. Intervention: The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | 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 LICART and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions (prescription label) | Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. |
| Ibuprofen | warnings | take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) |
| Lithium | drug interactions (prescription label) | Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of LICART and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … 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 … |
| Methotrexate | drug interactions (prescription label) | Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. |
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of LICART and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … 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 … |
| Naproxen | warnings | take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of LICART and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of LICART and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Propranolol | drug interactions | 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). … Intervention: During concomitant use of LICART and ACE-inhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
Every other medicine the diclofenac label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifampin | drug interactions | … of diclofenac whereas co- administration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac. … |
| Voriconazole | drug interactions | … CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas co- administration with CYP2C9 inducers (e.g. … |
| Warfarin | drug interactions (prescription label) | The effects of anticoagulants such as warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug … |
Other labels that name diclofenac
Source: FDA drug label (Voltaren Arthritis Pain), Haleon US Holdings LLC, effective February 11, 2025 (SPL set 30a94282-0892-442a-aa10-6525cbd4fe88), via openFDA; the full label on DailyMed
What do FAERS reports show for diclofenac?
The FDA Adverse Event Reporting System holds 158,675 reports that list diclofenac among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,957 are coded as a death and 43,208 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as diclofenac?
54 other medicines are given the same way (oral) and in the same FDA class as diclofenac or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain, Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain, Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Migraine, Pain, Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Acetaminophen and aspirin and caffeine | Pain | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain, Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain, Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Acetaminophen and ibuprofen | Pain | 51 labelers | $0.107 per unit 250-125 mg | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
Every medicine labeled for the same conditions as diclofenac
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does diclofenac compare with medicines for the same use?
21 side-by-side pages set diclofenac beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to diclofenac
- 54 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Diclofenac side effects
- the label's list beside FAERS reports
- Diclofenac shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other