Solage

Solage Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Solage (mequinol, tretinoin) Topical Solution is a combination of a depigmentation agent and a form of Vitamin A used to treat brown age spots, liver spots, or sun spots (solar lentigines). The brand name of this medication is discontinued, but generic versions may be available. Common side effects include temporary stinging, burning, irritation, peeling, redness, itching, or dry skin.

Apply Solage to the solar lentigines using the applicator tip while avoiding application to the surrounding skin. Use twice daily, morning and evening at least 8 hours apart, or as directed by a physician. Patients should not shower or bathe the treatment areas for at least 6 hours after application of Solage. Solage may interact with sulfa drugs, diuretics, antibiotics, or phenothiazines. Tell your doctor all medications and supplements you use. Solage must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Solage (mequinol, tretinoin) Topical Solution 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.

Solage 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.

Mequinol and tretinoin can cause some stinging, burning, warmth, tingling, itching, redness, swelling, dryness, peeling, or other skin irritation. Stop using the medication and call your doctor if any of these side effects become severe. You may need to use less of the medication or apply it less often.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Solage (Mequinol and Tretinoin) »

What is Patient Information Overview?

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

Solage Overview - Patient Information: Side Effects

SIDE EFFECTS: Temporary stinging, burning, irritation, peeling, redness, itching, or dry skin may occur. If any of these effects persist or worsen, notify 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.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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 Solage (Mequinol and Tretinoin)»

What is Prescribing information?

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

Solage FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the pivotal clinical trials, adverse reactions were primarily mild to moderate in intensity, occurring in 66% and 30% of patients, respectively. The majority of these events were limited to the skin and 64% had an onset of a skin related adverse reaction early in treatment (by week 8). The most frequent adverse reactions in patients treated with Solagé were erythema (49% of patients), burning, stinging, or tingling (26%), desquamation (14%), pruritus (12%), and skin irritation (5%). Some patients experienced temporary hypopigmentation of treated lesions (5%) or of the skin surrounding treated lesions (7%). Ninety-four of 106 patients (89%) had resolution of hypopigmentation upon discontinuation of treatment to the lesion, and/or re-instruction on proper application to the lesion only. Another 8% (9/106) of patients with hypopigmentation events had resolution within 120 days after the end of treatment. Three of the 106 patients (2.8%) had persistence of hypopigmentation beyond 120 days. Approximately 6% of patients discontinued study participation with Solagé due to adverse reactions. These discontinuations were due primarily to skin redness (erythema) or related cutaneous adverse reactions. Rare cases of depigmentation at sites distant from the application have been reported in Post Marketing Surveillance.

Adverse Events Occurring in > 1% of the Population - All Studies
Body System Solagé (mequinol 2% tretinoin 0.01%) Tretinoin, 0.01% Mequinol, 2%, Vehicle
Skin and Appendages N % N % N % N %
Erythema 613 41.1 261 55.3 13 5.1 8 4.6
Burning/Stinging/ Tingling 270 18.1 173 36.7 26 10.2 20 11.4
Desquamation 171 11.5 93 19.7 7 2.8 2 1.1
Pruritus 148 9.9 66 14.0 12 4.7 3 1.7
Irritation Skin* 90 6.0 25 5.3 1 0.4 1 0.6
Halo Hypopigmentation 96 6.4 16 3.4 2 0.8 2 1.1
Hypopigmentation 62 4.2 8 1.7 2 0.8 0 0.0
Skin Dry 46 3.1 18 3.8 3 1.2 1 0.6
Rash 31 2.0 21 4.4 0 0.0 1 0.6
Crusting 30 2.0 18 3.8 0 0.0 1 0.6
Rash Vesicular Bullae 18 1.2 8 1.7 0 0.0 0 0.0
Dermatitis 29 1.9 0 0.0 0 0.0 0 0.0
Discomfort Skin 52 3.5 0 0.0 0 0.0 0 0.0
Irritant Dermatitis 17 1.1 0 0.0 0 0.0 0 0.0
*In study RD.06.SRE.18091 irritant dermatitis included signs & symptoms of scaling, dryness, stinging/burning, and erythema.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of Solagé: skin discoloration, erythema, skin exfoliation, skin irritation, and skin burning sensation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Solage (Mequinol and Tretinoin) »

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Solage - User Reviews

Solage 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 Solage 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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