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.

Some side effects of Solaraze may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

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
  • Application site reactions, including skin rash; pain, tingling, or burning sensation
  • flu-like syndrome (body ache, headache, fever, with or without chills)
  • itching skin
Less common or rare
  • Blood in the urine
  • cough
  • dry, itching, or burning eyes
  • eye pain
  • headaches, including migraines
  • increased sensitivity of the skin
  • nasal congestion
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • redness or swelling of the eyes
  • 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

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
  • Burning skin
  • dry skin
  • scaly skin
  • thickened skin
  • tingling skin
Less common
  • Acne
  • back pain
  • belching
  • bleeding skin
  • chest pain
  • diarrhea
  • heartburn
  • indigestion
  • joint pain
  • lack or loss of strength
  • loss or thinning of the hair
  • muscle pain
  • neck pain
  • runny nose
  • stomach upset or pain

For Healthcare Professionals

Applies to diclofenac topical: topical film extended release, topical gel, topical solution

Local

Local application site reactions have been reported in 75% to 86% of patients and have included rash (35% to 36%), pruritus (31% to 52%), dry skin (25% to 27%), contact dermatitis (19% to 33%), pain (15% to 26%), paresthesia (8% to 20%), exfoliation (6% to 24%), vesiculobullous rash (4%), edema (3% to 4%), hyperesthesia (3%), photosensitivity reaction (3%), acne (1%), alopecia (1% to 2%), erythema (less than 1%), irritation (less than 1%), and papules (less than 1%).

The gel vehicle has also been associated with a high incidence of application site reactions (71% to 86%), including pruritus (45% to 59%), pain (22% to 30%), rash (17% to 20%), dry skin (12% to 17%), exfoliation (4% to 13%), and paresthesia (4% to 20%). Other local reactions have included skin carcinoma, hypertonia, lacrimation disorder, maculopapular rash, purpuric rash, skin hypertrophy, and vasodilation in less than 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus (4%), rash (2% to 4%), dry skin (3%), contact dermatitis (2%), pain (1% to 2%), skin carcinoma (2%), and skin ulcer (1% to 2%). Other dermatologic side effects have included skin hypertrophy, paresthesia, seborrhea, urticaria in less than 1% of patients, and skin discoloration. The gel vehicle has been associated with acne (1% to 2%), herpes simplex (2%), maculopapular rash (2%), and skin nodule (2%).

Cardiovascular

Cardiovascular side effects have included hypertension (1% to 2%), migraine (1%), and palpitation. The gel vehicle has been associated with phlebitis (2%).

Endocrine

Endocrine side effects have included hyperglycemia (greater than 1%).

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (2% to 3%), diarrhea (2%), abdominal pain (1% to 2%), dry mouth, gastroenteritis, mouth ulceration, nausea, rectal hemorrhage, and ulcerative stomatitis. The gel vehicle has been associated with constipation (2%).

Genitourinary

Genitourinary side effects have included hematuria (2%).

Hepatic

Hepatic side effects have included elevations in serum transaminases in up to 15% of patients as well as rare cases of hepatitis, jaundice, and fatal fulminant hepatitis. Liver injury is most likely to occur in older females in the first 6 months of use.

Immunologic

Immunologic side effects have included infection and flu syndrome (greater than 1%).

Metabolic

Metabolic side effects have included increased creatine phosphokinase (4%), increased SGOT (3%), increased SGPT (2%), increased creatinine (2%), hypercholesterolemia (1%), hyperglycemia (1%), and creatinine increased. The gel vehicle has been associated with edema (2%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (2 to 3%), arthralgia (2%), arthrosis (2%), and leg cramps.

Nervous system

Nervous system side effects have included headache (7%), hypokinesia (2%), depression, dizziness, drowsiness, lethargy, paresthesia, and paresthesia at application site. The gel vehicle has been associated with dizziness (4%) and anxiety (1% to 2%).

Ocular

Ocular side effects have included conjunctivitis (2 to 4%) eye pain (2%), blurred or abnormal vision, cataract, and eye disorder.

Respiratory

Respiratory side effects have included asthma, dyspnea, pharyngitis, pneumonia, rhinitis, and sinusitis in 2% of patients.

Renal

Renal side effects have included increased creatinine (2%).

Other

Other side effects have included flu syndrome (1 to 10%), accidental injury (4%), infection (4%), back pain (2 to 4%), asthenia (2%), neck pain (2%), pain (2%), chest pain (1 to 2%), ear pain, and taste perversion.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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