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Solaraze Side Effects

Generic Name: diclofenac topical

Note: This document contains side effect information about diclofenac topical. Some of the dosage forms listed on this page may not apply to the brand name Solaraze.

For the Consumer

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

Warning

Topical 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.

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.

Side effects requiring immediate medical attention

Along with its needed effects, diclofenac topical (the active ingredient contained in Solaraze) 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

  • Burning, itching, redness, skin rash, swelling, or soreness at the application site
  • itching skin

Less common

  • Blood in the urine
  • chest pain
  • cough
  • dry, itching, or burning eyes
  • eye pain
  • headaches, including migraines
  • increased sensitivity of the skin to sunlight
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • redness or swelling of the eyes
  • runny or stuffy nose
  • skin rash other than at the application site
  • sore throat
  • tightness in the chest
  • troubled breathing
  • ulcers or sores on the skin, other than at the application site

Side effects not requiring immediate medical attention

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

  • Chills
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • scaly, thick, or tingling skin
  • shivering
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

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. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Flector Patch (diclofenac topical)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.

3. "Product Information. Solaraze (diclofenac topical)" SkyePharma, San Diego, CA.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. "Product Information. Voltaren Topical (diclofenac topical)." Endo Laboratories LLC, Chadds Ford, PA.

6. "Product Information. Pennsaid (diclofenac topical)." Horizon Pharma USA Inc, Northbrook, IL.

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.