Diclofenac sodium (Solaraze) 3% gel is a topical non-steroidal anti-inflammatory drug (NSAID). It's prescribed for adults to treat actinic keratosis, a skin condition caused by too much exposure to ultraviolet light. Diclofenac sodium (Solaraze) 3% gel is applied directly to the affected area twice daily. Treatment usually takes about 2 to 3 months. Some of the more common side effects of this medication include itching, rash, and dry skin at the application site. Brand name Solaraze has been discontinued; diclofenac sodium (Solaraze) 3% gel is only available as a generic medication.
Actinic keratoses (AK) in adults
Actinic keratosis (AK) is a condition where your skin cells grow faster than normal. It results from too much exposure to ultraviolet (UV) light from the sun or tanning beds. If left untreated, AK can develop into skin cancer.
Diclofenac sodium (Solaraze) 3% gel is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking proteins in your body that help form new cells and blood vessels. Diclofenac sodium (Solaraze) 3% gel treats actinic keratoses (AK) by stopping abnormal skin cells from growing.
Source: DailyMed
Along with its needed effects, a medicine 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:
More common
Burning, itching, redness, skin rash, swelling, or soreness at the application site
itching skin
Less common
Blood in the urine
dry, itching, or burning eyes
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
tightness in the chest
troubled breathing
ulcers or sores on the skin, other than at the application site
Some side effects 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
Chills
general feeling of discomfort or illness
joint pain
loss of appetite
muscle aches and pains
scaly, thick, or tingling skin
shivering
sweating
trouble sleeping
unusual tiredness or weakness
vomiting
Less common
back pain
belching
bleeding skin
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
dizziness
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
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Milder side effects compared to some other AK medications
Skin might continue to improve even after you stop this medication
Don't need to be refrigerated; store at room temperature
Applied twice daily
Can make your skin more sensitive to the sun and put you at higher risk for sunburns
Not recommended for use if you have stomach bleeds or ulcers, or severe kidney or liver damage
Diclofenac sodium (Solaraze) 3% gel can continue to work for up to one month even after you stop treatment. You might see your skin continue to improve during this time. Let your dermatology team know if your skin doesn't get better.
After applying diclofenac sodium (Solaraze) 3% gel, wash your hands well before touching anything else. This prevents the medication from getting on and causing irritation to other parts of your body, such as your eyes. If it gets in your eyes or anywhere that it doesn't belong, rinse well with water and get medical help.
Limit or avoid exposure to sunlight, tanning beds, or UV lamps while using diclofenac sodium (Solaraze) 3% gel. This medication will make your skin more sensitive to the sun and other UV light and put you at higher risk for burns.
Don't use diclofenac sodium (Solaraze) 3% gel with other oral NSAIDs, such as ibuprofen (Advil) or naproxen (Aleve). Doing so puts you at higher risk for certain side effects, like stomach ulcers, stroke, and heart attack. NSAIDs are commonly found in over-the-counter pain and cold medications. Talk with your healthcare team or pharmacist if you're not sure whether you're already taking an NSAID.
Applying lotion, sunscreen, or makeup might affect how well your skin absorbs diclofenac sodium (Solaraze) 3% gel. Ask your dermatology team if you can apply these and other skin products with this medication.
Diclofenac sodium (Solaraze) 3% gel can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: History of heart problems, including heart attack | Using high doses of diclofenac sodium (Solaraze) 3% gel | Using diclofenac sodium (Solaraze) 3% gel for a long time | History of heart bypass surgery
NSAIDs like diclofenac sodium (Solaraze) 3% gel can raise your risk of having blood clots, heart attacks, or strokes. This can happen as early as within the first weeks of starting this medication. People with heart problems, those using high doses of diclofenac sodium (Solaraze) 3% gel, and those using diclofenac sodium (Solaraze) 3% gel for a long time have a higher risk of this happening. That’s why it’s important to use the lowest possible dose for the shortest possible time. If you have heart problems, talk to your healthcare team before starting this medication. Don't use diclofenac sodium (Solaraze) 3% gel if you've had or will be having heart bypass surgery. Call 911 or seek immediate medical help if you experience chest pain, trouble breathing, weakness on one side of your body, or trouble speaking or walking.
Risk factors: Heart failure | Taking certain medications, such as water pills, ACEIs, and ARBs
NSAIDs including diclofenac sodium (Solaraze) 3% gel can cause your body to hold onto more water. This can lead to new or worsening heart failure and swelling of your arms and legs. Diclofenac sodium (Solaraze) 3% gel can also cause some medications used to treat these conditions to be less effective, such as furosemide (Lasix), lisinopril (Zestril), and losartan (Cozaar).Diclofenac sodium (Solaraze) 3% gel isn't recommended if you have severe heart failure, so discuss with your healthcare team before starting this medication. Let your healthcare team know right away if you experience any symptoms, such as trouble breathing, tiredness, swelling in your body, or sudden weight gain.
Risk factors: Asthma and stuffy nose with or without nasal polyps | Allergic reaction to aspirin or other NSAIDs
Diclofenac sodium (Solaraze) 3% gel can cause your airways to tighten, which might lead to severe asthma attacks. Be careful using this medication if you have asthma. People who've experienced asthma attacks triggered by aspirin (Aspir-Low) or other NSAIDs in the past should avoid diclofenac sodium (Solaraze) 3% gel. Get medical help right away if your throat tightens and you can't breathe.
Diclofenac sodium (Solaraze) 3% gel might cause sudden, very serious, and sometimes life-threatening allergic and skin reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome. Symptoms include fever, body aches, rash, peeling skin, painful blisters all over your body, and swelling of the face. Stop the medication and get help right away if you experience these symptoms.
Risk factors: Currently pregnant
If diclofenac sodium (Solaraze) 3% gel is used during or after the second trimester of pregnancy, it can lower the amniotic fluid (the fluid that surrounds the baby in the womb). This can occur as soon as 2 days after starting the medication and result in serious kidney problems in your unborn baby. Babies born to mothers who use diclofenac sodium (Solaraze) 3% gel starting in the third trimester of pregnancy or later can also develop heart problems. If you're thinking of getting pregnant or becoming pregnant, talk to your healthcare team about the risks and benefits of using diclofenac sodium (Solaraze) 3% gel.
Adults: The typical dose is to apply to the affected area(s) 2 times a day. Use enough gel to cover each skin lesion (abnormal area of skin growth). Your dermatologist will instruct you to use the lowest dose of this medication for the shortest amount of time needed to treat your condition. Typically, treatment lasts 2 to 3 months.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Heart bypass surgery
Face or scalp actinic keratosis (scaly precancerous spot or growth on the skin) in adults - all brands and strengths
Genital and anal warts in adults and children 12 years and older - Zyclara 3.75% and Aldara 5% only
Superficial basal cell carcinoma (a type of skin cancer) in adults - Aldara 5% only
Actinic (or solar) keratosis (scaly pre-cancerous spot or growth on the skin) in adults
Basal cell carcinoma (certain type of skin cancer) in adults
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Alembic Pharmaceuticals Inc. (2024). Diclofenac sodium- diclofenac sodium topical gel [package insert]. DailyMed.
Del Regno, L., et al. (2022). A review of existing therapies for actinic keratosis: current status and future directions. American Journal of Clinical Dermatology.
Nelson, C. G. (2011). Diclofenac gel in the treatment of actinic keratoses. Therapeutics and Clinical Risk Management.
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