Solage
Solage Side Effects Center
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
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) »
Additional Solage Information
Solage - User Reviews
Solage User Reviews
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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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