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    HomeMedication GuideDiclofenac safety
    Nonsteroidal anti-inflammatory drug (NSAID)

    Diclofenac: What to Know Before You Take It

    Also known as Voltaren, Cambia

    A patient-focused safety profile with information from public regulatory sources.

    Reviewed by the OmniRx Health clinical team•Last reviewed Jul 4, 2026

    In plain language

    What Diclofenac is used for

    Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) 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.

    Read before you decide

    Risks and precautions

    Risks and warnings

    Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening blisters facial swelling shock rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in the eyes, nose or mouth Ask a doctor before us if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if pain gets worse or lasts more than 21 days redness or swelling is present in the painful area fever occurs skin irritation occurs any new symptoms appear. These could be signs of a serious condition. you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling weakness in one part or side of body slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

    Medication review

    Diclofenac drug interactions

    Diclofenac + CelecoxibNSAIDs 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.Major interactionDiclofenac + IndomethacinNSAIDs 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.Major interactionDiclofenac + NaproxenNSAIDs 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.Major interactionDiclofenac + AspirinWarnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.Minor interactionDiclofenac + DigoxinConivaptan 33% 43% Diltiazem 20% NA Indomethacin 40% NA Mirabegron 29% 27% Nefazodone 27% 15% Nifedipine 45% NA Propantheline 24% 24% Quinine NA 33% Rabeprazole 29% 19% Saquinavir 27% 49% Spironolactone 25% NA Telmisartan 20 to 49% NA Tricagrelor 31% 28% Tolvaptan 30% 20% Trimethoprim 22 to 28% NA Digoxin concentrations increased, but magnitude is unclear Alprazolam, azithromycin, cyclosporine, diclofenac, diphenoxylate, epoprostenol, esomeprazole, ibuprofen, ketoconazole, lansoprazole, metfo…Minor interactionDiclofenac + FluconazoleAlthough not specifically studied, fluconazole has the potential to increase the systemic exposure of other non-steroidal anti-inflammatory drugs (NSAIDs) that are metabolized by CYP2C9 (e.g., naproxen, lornoxicam, meloxicam, diclofenac).Minor interactionDiclofenac + IbuprofenThe chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.Minor interactionDiclofenac + WarfarinTable 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafax…Minor interaction
    Check this against your full medication list in the Interaction Checker

    FDA safety data

    Most-reported side effects

    Based on 162,477 FAERS reports. Reports do not prove the drug caused the effect.

    drug ineffective 31,967pain 16,019fatigue 14,048off label use 13,759product use in unapproved indication 13,476arthralgia 11,413rash 10,974rheumatoid arthritis 10,764nausea 9,822abdominal discomfort 9,734product use issue 9,438joint swelling 9,031
    Explore full FDA safety data

    Regulatory record

    FDA recalls (11)

    Class IIOngoing · Jan 27, 2026

    Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IIIOngoing · Dec 22, 2025

    Failed PH Specifications

    Recalling firm: Cipla USA, Inc.

    Class IIOngoing · Jun 22, 2023

    Defective Delivery System

    Recalling firm: ALEMBIC PHARMACEUTICALS, INC.

    Class IICompleted · Jul 2, 2019

    Lack of Assurance of Sterility

    Recalling firm: Altaire Pharmaceuticals, Inc.

    Class IICompleted · Jul 2, 2019

    Lack of Assurance of Sterility

    Recalling firm: Altaire Pharmaceuticals, Inc.

    Class IITerminated · Sep 26, 2014

    Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

    Recalling firm: Actavis Laboratories, FL, Inc.

    Class IITerminated · Apr 24, 2014

    Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

    Recalling firm: Actavis Laboratories, FL, Inc.

    Class IITerminated · Apr 24, 2014

    Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

    Recalling firm: Actavis Laboratories, FL, Inc.

    Class IITerminated · Dec 20, 2013

    Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

    Recalling firm: Watson Laboratories, Inc.-(Actavis) - Florida

    Class IITerminated · Mar 22, 2013

    Failed Tablet/Capsule Specifications: Broken tablets

    Recalling firm: Watson Laboratories, Inc.-(Actavis) - Florida

    Class IITerminated · Mar 22, 2013

    Failed Tablet/Capsule Specifications: Broken tablets

    Recalling firm: Actavis Inc

    Common questions

    Patient questions

    What is Diclofenac prescribed for?

    Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) 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.

    What are the key warnings and safety precautions for Diclofenac?

    Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening blisters facial swelling shock rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in the eyes, nose or mouth Ask a doctor before us if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if pain gets worse or lasts more than 21 days redness or swelling is present in the painful area fever occurs skin irritation occurs any new symptoms appear. These could be signs of a serious condition. you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling weakness in one part or side of body slurred speech If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

    Does Diclofenac interact with other medications or foods?

    Diclofenac has 8 documented drug interaction(s) and 0 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.