Note: This document contains side effect information about diclofenac topical. Some dosage forms listed on this page may not apply 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.
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 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]
