Solaraze Side Effects

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

Side Effects of Solaraze - for the Consumer

Solaraze Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Solaraze Gel:

Dry skin; flu-like symptoms; peeling, scaling, or flaking of the skin.

Seek medical attention right away if any of these SEVERE side effects occur when using Solaraze Gel:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; chest pain; eye redness or swelling (conjunctivitis); inflammation, swelling, or severe irritation of the skin; muscle pain; open sores on the skin (ulcers); shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Solaraze Side Effects - for the Professional

Solaraze

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.

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Side Effects by Body System - for Healthcare Professionals

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.

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