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Solaraze

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Solaraze

Solaraze

Solaraze Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Solaraze (diclofenac sodium) Gel is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body. It is a non-steroidal anti-inflammatory drug (NSAID). Common side effects include rash, scaling, dry skin, or itching at application site.

Solaraze Gel is applied to lesion areas twice daily. Smooth onto affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Solaraze Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of therapy is 60 to 90 days. Solaraze may interact with blood thinners, cyclosporine, lithium, methotrexate, diuretics (water pills), steroids, or ACE inhibitors. Tell your doctor all medications you are taking. During the first 6 months of pregnancy, Solaraze should be used only when prescribed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the fetus and problems with normal labor/delivery. Based on information from related drugs, this medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Our Solaraze (diclofenac sodium) Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Solaraze in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • pale or yellowed skin, dark colored urine, confusion;
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, stomach pain, upset stomach;
  • diarrhea, gas; or
  • mild itching, dryness, redness, scaling, or other skin irritation where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Solaraze (Diclofenac Sodium) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Solaraze Overview - Patient Information: Side Effects

SIDE EFFECTS: Rash, scaling, dry skin, swelling, or itching may occur at application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling of the ankles/feet/hands (edema), sudden/unexplained weight gain, unusual tiredness, change in the amount of urine.

Other medications similar to this medication may infrequently cause serious bleeding from the stomach or intestines. Also, related drugs rarely have caused blood clots to form, resulting in heart attacks and strokes. If you notice any of the following rare but very serious side effects, stop using this medication and seek immediate medical attention: black/bloody stools, vomit that looks like coffee grounds, chest pain, sudden vision changes, weakness on one side of the body, slurred speech.

This drug may rarely cause serious (possibly fatal) liver problems. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Solaraze (Diclofenac Sodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Solaraze FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with Solaraze® drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the Solaraze®-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced one or more adverse events (AEs) during the studies. The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy.

Of the 211 patients treated with Solaraze®, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. Application site reactions (ASRs) were the most frequent AEs in both Solaraze®-and vehicle-treated groups. Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the Solaraze® group than in the vehicle-treated patients.

Eighteen percent of Solaraze®-treated patients and 4% of vehicle-treated patients discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions.

Table 1 below presents the AEs reported at an incidence of > 1% for patients treated with either Solaraze® Gel or vehicle (60- and 90-day treatment groups) during the phase 3 studies.

Table 1. Adverse Events Reported ( > 1% in Any Treatment Group) During Solaraze® Phase 3 Clinical Trials Incidences for 60-Day and 90-Day Treatments

  60-day Treatment 90-day Treatment
Solaraze® (%) Gel Vehicle (%) Solaraze® (%) Gel Vehicle (%)
N=48 N=49 N=114 N=114
BODY AS A WHOLE 21 20 20 18
Abdominal Pain 2 0 1 0
Accidental Injury 0 0 4 2
Allergic Reaction 0 0 1 3
Asthenia 0 0 2 0
Back Pain 4 0 2 2
Chest Pain 2 0 1 0
Chills 0 2 0 0
Flu Syndrome 10 6 1 4
Headache 0 6 7 6
Infection 4 6 4 5
Neck Pain 0 0 2 0
Pain 2 0 2 2
CARDIOVASCULAR SYSTEM 2 4 3 1
Hypertension 2 0 1 0
Migraine 0 2 1 0
Phlebitis 0 2 0 0
DIGESTIVE SYSTEM 4 0 6 8
Constipation 0 0 0 2
Diarrhea 2 0 2 3
Dyspepsia 2 0 3 4
METABOLIC AND NUTRITIONAL DISORDERS 2 8 7 2
Creatine Phosphokinase Increased 0 0 4 1
Creatinine Increased 2 2 0 1
Edema 0 2 0 0
Hypercholesteremia 0 2 1 0
Hyperglycemia 0 2 1 0
SGOT Increased 0 0 3 0
SGPT Increased 0 0 2 0
MUSCULOSKELETAL SYSTEM 4 0 3 4
Arthralgia 2 0 0 2
Arthrosis 2 0 0 0
Myalgia 2 0 3 1
NERVOUS SYSTEM 2 2 2 5
Anxiety 0 2 0 1
Dizziness 0 0 0 4
Hypokinesia 2 0 0 0
RESPIRATORY SYSTEM 8 8 7 6
Asthma 2 0 0 0
Dyspnea 2 0 2 0
Pharyngitis 2 8 2 4
Pneumonia 2 0 0 1
Rhinitis 2 2 2 2
Sinusitis 0 0 2 0
SKIN AND APPENDAGES 75 86 86 71
Acne 0 2 0 1
Application Site Reaction 75 71 84 70
Acne 0 4 1 0
Alopecia 2 0 1 1
Contact Dermatitis 19 4 33 4
Dry Skin 27 12 25 17
Edema 4 0 3 0
Exfoliation 6 4 24 13
Hyperesthesia 0 0 3 1
Pain 15 22 26 30  
Paresthesia 8 4 20 20
Photosensitivity Reaction 0 2 3 0
Pruritus 31 59 52 45
Rash 35 20 46 17
Vesiculobullous Rash 0 0 4 1
Contact Dermatitis 2 0 0 0
Dry Skin 0 4 3 0
Herpes Simplex 0 2 0 0
Maculopapular Rash 0 2 0 0
Pain 2 2 1 0
Pruritus 4 6 4 1
Rash 2 10 4 0
Skin Carcinoma 0 6 2 2
Skin Nodule 0 2 0 0
Skin Ulcer 2 0 1 0
SPECIAL SENSES 2 0 4 2
Conjunctivitis 2 0 4 1
Eye Pain 0 2 2 0
UROGENITAL SYSTEM 0 0 4 5
Hematuria 0 0 2 1
OTHER 0 0 0 3
Procedure 0 0 0 3

Skin and Appendages Adverse Events Reported for Solaraze® at Less Than 1 % Incidence in the Phase 3 Studies: skin hypertrophy, paresthesia, seborrhea, urticaria, application site reactions (skin carcinoma, hypertonia, skin hypertrophy lacrimation disorder, maculopapular rash, purpuric rash, vasodilation).

Adverse Reactions Reported for Oral Diclofenac Dosage Form (not topical Solaraze® Gel): *Incidence greater than 1% marked with asterisk.

Body as a Whole: abdominal pain or cramps*, headache*, fluid retention*, abdominal distention*, malaise, swelling of lips and tongue, photosensitivity, anaphylaxis, anaphylactoid reactions, chest pain.

Cardiovascular: hypertension, congestive heart failure, palpitations, flushing, tachycardia, premature ventricular contractions, myocardial infarction, hypotension.

Digestive: diarrhea*, indigestion*, nausea*, constipation*, flatulence*, liver test abnormalities*, PUB*, i.e., peptic ulcer, with or without bleeding and/or perforation, or bleeding without ulcer, vomiting, jaundice, melena, esophageal lesions, aphthous stomatitis, dry mouth and mucous membranes, bloody diarrhea, hepatitis, hepatic necrosis, cirrhosis, hepatorenal syndrome, appetite change, pancreatitis with or without concomitant hepatitis, colitis, intestinal perforation.

Hemic and Lymphatic: hemoglobin decrease, leukopenia, thrombocytopenia, eosinophilia, hemolytic anemia, aplastic anemia, agranulocytosis, purpura, allergic purpura, bruising.

Metabolic and Nutritional Disorders: azotemia, hypoglycemia, weight loss.

Nervous System: dizziness*, insomnia, drowsiness, depression, diplopia, anxiety, irritability, aseptic meningitis, convulsions, paresthesia, memory disturbance, nightmares, tremor, tic, abnormal coordination, disorientation, psychotic reaction.

Respiratory: epistaxis, asthma, laryngeal edema, dyspnea, hyperventilation, edema of pharynx.

Skin and Appendages: rash*, pruritus*, alopecia, urticaria, eczema, dermatitis, bullous eruption, erythema multiforme major, angioedema, Stevens-Johnson syndrome, excess perspiration, exfoliative dermatitis.

Special Senses: tinnitus*, blurred vision, taste disorder, reversible and irreversible hearing loss, scotoma, vitreous floaters, night blindness, amblyopia.

Urogenital: nephrotic syndrome, proteinuria, oliguria, interstitial nephritis, papillary necrosis, acute renal failure, urinary frequency, nocturia, hematuria, impotence, vaginal bleeding.

Read the entire FDA prescribing information for Solaraze (Diclofenac Sodium) »

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Solaraze - User Reviews

Solaraze User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Solaraze sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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