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Diclofenac topical Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 17, 2023.

Applies to diclofenac topical: topical application cream, topical application gel/jelly, topical application patch extended release, topical application solution, topical application spray.

Warning

Topical application route (Patch, 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 epolamine 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.

Topical application route (Gel/Jelly; 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 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.

Serious side effects of Diclofenac topical

Along with its needed effects, diclofenac topical 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 topical:

More common

Less common

Incidence not known

Other side effects of Diclofenac topical

Some side effects of diclofenac topical 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

Less common

For Healthcare Professionals

Applies to diclofenac topical: topical cream, topical film extended release, topical gel, topical kit, topical solution.

General

The most frequently reported side effects were application site reactions.[Ref]

Local

Very common (10% or more): Dryness (up to 32%)

Common (1% to 10%): Dermatitis, burning sensation, pruritus, exfoliation, erythema, pain, induration, rash, scabbing, contusion, inflammation, irritation, itching, tingling, blistering, localized paresthesia

Frequency not reported: Vesicles, papules, localized hair discoloration, vasodilation, purpuric rash, atrophy[Ref]

Dermatologic

Common (1% to 10%): Contact dermatitis, eczema, dry skin, rash, scaly rash, skin hypertrophy, skin ulcer, vesiculobullous rash, exfoliation, urticaria, acne, alopecia, skin nodule

Uncommon (0.1% to 1%): Face edema, maculopapular rash, photosensitivity reaction, seborrhea

Rare (0.01% to 0.1%): Bullous dermatitis

Very rare (less than 0.01%): Pustular rash

Frequency not reported: Skin hypertrophy[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Hemorrhage

Postmarketing reports: Palpitation, cardiovascular disorder, blood pressure increased[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, halitosis, nausea, flatulence, constipation

Very rare (less than 0.01%): Gastrointestinal hemorrhage

Frequency not reported: Upper abdominal pain

Postmarketing reports: Dry mouth, gastroenteritis, mouth ulceration, rectal hemorrhage, ulcerative stomatitis, lip swelling, swollen tongue[Ref]

Nervous system

Common (1% to 10%): Headache, migraine, hypokinesia, dysgeusia, somnolence, hypertonia, hyperesthesia, paresthesia

Postmarketing reports: Dizziness, drowsiness, lethargy, taste perversion[Ref]

Renal

Common (1% to 10%): Creatinine increased

Very rare (less than 0.01%): Renal failure[Ref]

Hepatic

Common (1% to 10%): SGOT increased, SGPT increased[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia, hyperglycemia

Postmarketing reports: Appetite decreased[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, neck pain, arthralgia, arthrosis, myalgia

Postmarketing reports: Leg cramps[Ref]

Ocular

Common (1% to 10%): Eye pain, conjunctivitis

Uncommon (0.1% to 1%): Lacrimation disorder

Postmarketing reports: Abnormal vision, blurred vision, cataract, eye disorder[Ref]

Respiratory

Common (1% to 10%): Asthma, dyspnea, pharyngitis, pneumonia, rhinitis, sinusitis, sinus congestion

Postmarketing reports: Laryngismus, laryngitis[Ref]

Other

Common (1% to 10%): Accidental injury, asthenia, chest pain, flu-like syndrome, infection, pain, creatine phosphokinase increased, edema

Postmarketing reports: Lack of drug effect, body odor, ear pain[Ref]

Oncologic

Common (1% to 10%): Skin carcinoma[Ref]

Genitourinary

Common (1% to 10%): Hematuria, urinary tract infection[Ref]

Immunologic

Common (1% to 10%): Allergic reaction[Ref]

Psychiatric

Postmarketing reports: Depression[Ref]

References

1. Product Information. Solaraze (diclofenac topical). SkyePharma Inc. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. Voltaren Topical (diclofenac topical). Endo Laboratories LLC. 2016.

5. Product Information. Pennsaid (diclofenac topical). Horizon Therapeutics USA Inc. 2016.

6. Product Information. Flector Patch (diclofenac topical). Actavis U.S. (Alpharma USPD). 2016.

Further information

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.