Diclofenac Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 27, 2024.

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

Important Warnings This medicine can cause some serious health issues

Oral route (Capsule)

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.

Diclofenac is contraindicated in the setting of CABG surgery.

NSAIDs also cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Oral route (Tablet, Delayed Release; Tablet, Enteric Coated; Tablet, Extended Release)

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.

Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft surgery.

NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Oral route (Tablet; Capsule, Liquid Filled; Powder for Solution)

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.

Diclofenac is contraindicated in the setting of coronary artery bypass graft surgery.

NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

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:

More common

• acid or sour stomach
• belching
• bleeding gums
• blood in the urine or stools
• bloody or black, tarry stools
• burning while urinating
• chest pain
• chills
• cough
• clay-colored stools
• cloudy urine
• constipation
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• dizziness
• feeling of indigestion
• fever
• frequent urge to urinate
• headache
• heartburn
• increased bleeding time
• indigestion
• itching skin or rash
• light-colored stools
• loss of appetite
• nausea and vomiting
• pain in the chest below the breastbone
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• stomach bloating, burning, cramping, discomfort, upset, or pain
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling or inflammation of the mouth
• swollen glands
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting of blood or material that looks like coffee grounds
• weight loss
• yellow eyes and skin

Less common

• blistering, peeling, loosening of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• confusion
• change in consciousness
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of constant movement of self or surroundings
• feeling sad or empty
• irritability
• joint or muscle pain
• lack of appetite
• lack or loss of strength
• loss of consciousness
• loss of interest or pleasure
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pale or blue lips, fingernails, or skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness, soreness, or itching skin
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• stiff neck or back
• trembling or shaking of the hands or feet
• trouble concentrating
• trouble sleeping

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:

More common

• bloated
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty in swallowing
• excess air or gas in the stomach or intestines
• hearing loss
• lack or loss of strength
• pain or burning in the throat
• passing gas

Less common

• burning, dry or itching eyes
• discharge, excessive tearing
• hair loss, thinning of the hair
• increased sensitivity of the skin to sunlight
• pain in the arms or legs
• redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
• redness or other discoloration of the skin
• severe sunburn

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.

General

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 the drug diclofenac have narcotics in it?

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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer