Solaraze Side Effects

Generic name: diclofenac topical

Medically reviewed by Drugs.com. Last updated on May 5, 2024.

Note: This document provides detailed information about Solaraze Side Effects associated with diclofenac topical. Some dosage forms listed on this page may not apply specifically to the brand name Solaraze.

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

Important Warnings This medicine can cause some serious health issues

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 Solaraze

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 or tightness
• 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
• trouble breathing
• ulcers or sores on the skin, other than at the application site

Incidence not known

• black, tarry stools
• chills
• fever
• painful or difficult urination
• sores, ulcers, or white spots on lips or in mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of Solaraze

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

• diarrhea
• 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
• vomiting

Less common

• acne
• back pain
• belching
• bleeding skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dizziness
• heartburn
• increase in body movements
• indigestion
• lack or loss of strength
• loss of or change in taste
• loss or thinning of the hair
• neck pain
• sleepiness or unusual drowsiness
• stomach upset or pain

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]

Further information

Solaraze 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