Diclofenac Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 17, 2024.

Applies to diclofenac: oral capsule, oral capsule liquid filled, oral powder for solution, oral tablet, oral tablet enteric coated, oral tablet extended release.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a long time.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain medicines (eg, steroid medicine, blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. It may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using too much of Cambia® or any other migraine medicines (eg, ergotamine, triptans, opioids, NSAIDs, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.

Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of meningitis.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of diclofenac

Along with its needed effects, diclofenac may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diclofenac:

Get emergency help immediately if any of the following symptoms of overdose occur while taking diclofenac:

Symptoms of overdose

• agitation
• blurred vision
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• confusion
• depression
• difficult or trouble breathing
• hives
• hostility
• irregular, fast or slow, or shallow breathing
• irritability
• loss of consciousness
• muscle twitching
• nervousness
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• sleepiness
• slow or fast heartbeat
• stupor
• swelling of the face, ankles, or hands
• tightness in the chest
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects of diclofenac

Some side effects of diclofenac may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

See also:

For healthcare professionals

Applies to diclofenac: compounding powder, intravenous solution, oral capsule, oral delayed release tablet, oral powder for reconstitution, oral tablet, oral tablet extended release, rectal suppository, transdermal film extended release.

General adverse events

The most common adverse reactions among patients treated with this drug included; gastrointestinal events of abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding,/perforation, heartburn, nausea, gastric and duodenal ulcers, and vomiting; abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.

Hepatic

• Common (1% to 10%): Elevated liver enzymes
• Rare (less than 0.1%): Hepatitis, jaundice, liver disorder
• Very rare (less than 0.01%): Fulminant hepatitis, hepatic necrosis, hepatic failure
• Postmarketing reports: Drug-induced hepatotoxicity^[Ref]

Borderline elevations of 1 or more liver tests to less than 3 times the upper limit of the normal (3 x ULN) or greater elevations in transaminases occurred in about 15% of patients treated with this drug. Elevations to greater than 3 x ULN of AST occurred in about 2% (n=5700) of patients at some point during treatment. In an open-labeled trial among patients receiving NSAIDs, a higher incidence of transaminase elevations were observed in patients receiving diclofenac compared with other NSAIDs.^[Ref]

Renal

• Common (1% to 10%): Abnormal renal function, increased serum creatinine
• Rare (less than 0.1%): Nephrotic syndrome, interstitial nephritis, renal papillary necrosis, acute renal failure, urinary frequency, nocturia, proteinuria, and hematuria^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, rashes
• Rare (less than 0.1%): Angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
• Very rare (less than 0.01%): Bullous eruptions, eczema, erythema, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction
• Frequency not reported: Increased sweating^[Ref]

Hematologic

• Common (1% to 10%): Anemia, increased bleeding time
• Rare (less than 0.1%): Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
• Very rare (less than 0.01%): Thrombocytopenia, leukopenia, positive Coombs' test
• Frequency not reported: Ecchymosis, eosinophilia, melena, purpura, rectal bleeding^[Ref]

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Urticaria, rash, angioedema, bronchospasm
• Rare (less than 0.1%): Anaphylactic reactions
• Very rare (less than 0.01%): Angioneurotic edema (including facial edema)^[Ref]

Metabolic

• Rare (less than 0.1%): Changes in appetite, hyperglycemia
• Frequency not reported: Weight changes^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, headaches
• Rare (less than 0.1%): Meningitis
• Very rare (less than 0.01%): Memory impairment
• Frequency not reported: Confusion, drowsiness, insomnia, paresthesia, tremors^[Ref]

Cardiovascular

• Common (1% to 10%): Edema
• Uncommon (0.1% to 1%): Cardiac failure, chest pain
• Rare (less than 0.1%): Arrhythmia, hypotension, myocardial infarction, palpitations
• Very rare (less than 0.01%): Vasculitis
• Frequency not reported: Congestive heart failure, tachycardia, syncope, hypertension^[Ref]

Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.

Pharmacoepidemiological data reveal an increased risk of arteriothrombotic events associated with diclofenac use, particularly at a high dose and during long-term treatment. In a meta-analysis of long-term treatment with diclofenac 150 mg/day, compared with placebo use of this drug resulted in approximately 3 additional major vascular events per 1000 participants.^[Ref]

Psychiatric

• Rare (less than 0.1%): Hallucinations
• Very rare (less than 0.01%): Disorientation, depression, nightmare, irritability, psychotic disorder
• Frequency not reported: Anxiety, nervousness^[Ref]

Other

• Common (1% to 10%): Tinnitus,
• Rare (less than 0.1%): Hearing impairment
• Frequency not reported: Fever, asthenia, vertigo^[Ref]

Ocular

• Rare (less than 0.1%): Conjunctivitis
• Very rare (less than 0.01%): Blurred vision, visual disturbance, diplopia
• Frequency not reported: Optic neuritis

Gastrointestinal

• Very common (10% or more): Nausea (up to 24%), constipation (up to 13%)
• Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, gastric and duodenal ulcers, vomiting
• Rare (less than 0.1%): Colitis, eructation, pancreatitis
• Frequency not reported: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, stomatitis^[Ref]

NSAIDs including this drug, can cause serious gastrointestinal (GI) events which can occur at any time, with or without warning. For patients who develop a serious upper GI event, only about 20% were symptomatic. Upper GI ulcers, gross bleeding, or perforation occurred in approximately 1% of patients treated with NSAIDs for 3 to 6 months and 2% to 4% of patients treated for 1 year. Patients with a prior history of peptic ulcer disease and/or GI bleeding had a greater than 10-fold increased risk for developing a GI bleed than patients with neither of these risk factors.^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Frequency not reported: Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria

Immunologic

• Frequency not reported: Infection, sepsis

Local

• Common (1% to 10%): Local reactions such as itching, burning, and increased bowel movement with suppository use
• Very rare (less than 0.01%): Exacerbation of hemorrhoids with suppository use

Respiratory

• Common (1% to 10%): Sinusitis, upper respiratory infection, nasopharyngitis, bronchitis
• Rare (less than 0.1%): Pneumonia
• Frequency not reported: Asthma, dyspnea

Frequently asked questions

• Can I take ibuprofen with blood pressure medications?
• Which painkiller should you use?
• Why is diclofenac prescription only but ibuprofen is OTC?
• Can NSAIDs be used to treat a COVID-19 fever?
• Does diclofenac contain narcotics or affect a drug test?

Further information

Diclofenac side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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