Safety information
What to know before you start
Compounded by a pharmacy, so it is not FDA-approved. The FDA does not review a compounded preparation before it is dispensed, and a combination does not inherit the approval of any ingredient in it.
Azelaic acid
A topical acid approved on its own for acne and for the inflammatory lesions of rosacea.
Not for
- Anyone who has reacted to azelaic acid before.
Common effects
- Burning, stinging or tingling when applied.
- Dryness, scaling, itching and redness.
Serious effects
- Lightening of the skin, which may be more noticeable and less wanted on darker skin.
- Worsening of asthma has been reported.
Get medical help if
- Wheezing or shortness of breath.
- Swelling of the lips, tongue or face.
Tell your provider
- If you have asthma.
- If your skin lightens unevenly where you apply it.
Sources
- Azelaic acid topical prescribing information. US Food and Drug Administration. FDA-approved labeling
Ivermectin
A topical approved on its own for the inflammatory lesions of rosacea.
Not for
- Anyone who has reacted to ivermectin before.
Common effects
- Burning, irritation, itching and dry skin.
- A temporary worsening of rosacea early on.
Serious effects
- Severe skin irritation or allergic reaction.
Get medical help if
- Swelling of the lips, tongue or face, or trouble breathing.
Tell your provider
- If your rosacea worsens rather than settles after the first weeks.
Sources
- Ivermectin cream 1% prescribing information. US Food and Drug Administration. FDA-approved labeling
Metronidazole
A topical approved on its own for the inflammatory lesions of rosacea.
Not for
- Anyone who has reacted to metronidazole before.
Handling
- Avoid contact with the eyes.
Common effects
- Burning, stinging, dryness, itching and redness.
Serious effects
- Skin irritation severe enough to stop treatment.
- Allergic reaction.
Get medical help if
- Swelling of the lips, tongue or face, or trouble breathing.
- Eye irritation that does not settle.
Tell your provider
- Any history of blood disorders, which the oral form's labeling notes.
Sources
- Metronidazole topical gel prescribing information. US Food and Drug Administration. FDA-approved labeling
Clindamycin
A topical antibiotic approved on its own for acne vulgaris.
Not for
- Anyone with a history of ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
- Anyone who has reacted to clindamycin or lincomycin.
Common effects
- Dryness, peeling, itching, burning and redness where applied.
Serious effects
- Diarrhea, bloody diarrhea and colitis, including pseudomembranous colitis, have been reported with topical clindamycin. Labeling warns that clindamycin given by mouth or injection has been associated with severe colitis that may end fatally.
Get medical help if
- Diarrhea that is severe, persistent, or bloody, during use or in the weeks after stopping.
- Severe abdominal cramping.
Tell your provider
- Any history of bowel disease or of colitis after an antibiotic.
- Any diarrhea that starts while you are using it.
Sources
- Clindamycin phosphate topical prescribing information. US Food and Drug Administration. FDA-approved labeling
- Clindamycin phosphate topical prescribing information, Warnings. US Food and Drug Administration. FDA-approved labeling
Tranexamic acid
A drug approved orally for heavy menstrual bleeding. Its use for skin pigmentation, oral or topical, is off-label and not FDA-approved.
Tranexamic acid is not FDA-approved for melasma or any skin indication. Using it this way is off-label, which a provider may do and should explain.
Not for
- Anyone with active clotting disease, or a history of blood clots, without discussing it with the prescriber.
Common effects
- Irritation where applied.
Serious effects
- The oral drug's concern is clotting. Systemic absorption from a compounded topical has not been characterized.
Get medical help if
- Chest pain, shortness of breath, or pain and swelling in one leg.
- Sudden vision change.
Tell your provider
- Any personal or family history of blood clots.
- Any hormonal contraception you take, which also affects clotting risk.
Sources
- Tranexamic acid prescribing information. US Food and Drug Administration. FDA-approved labeling
Hydrocortisone
A topical corticosteroid, included here in a formulation intended for long-term use on the face.
Not for
- Use on skin infections that are not being treated.
- Anyone who has reacted to a topical steroid.
Handling
- Use for the shortest period the prescriber directs. Facial skin thins faster than skin elsewhere.
Common effects
- Burning, itching, dryness.
Serious effects
- Skin thinning (atrophy), stretch marks and visible small blood vessels with prolonged use.
- Steroid-induced rosacea or perioral dermatitis on the face.
- Rebound worsening when a long course is stopped abruptly.
Get medical help if
- Skin that becomes thin, shiny or easily bruised.
- A rash that worsens or spreads.
Tell your provider
- How long you have been using it. Continuous facial use is the situation the cautions are about.
- Any other steroid you use, including inhaled or oral.
Sources
- Hydrocortisone topical prescribing information. US Food and Drug Administration. FDA-approved labeling
Hydroquinone
A skin-lightening agent. There is no FDA-approved over-the-counter hydroquinone product, and the FDA has warned consumers about unapproved ones.
Not for
- Anyone who has reacted to hydroquinone before.
- Use on broken or irritated skin.
Handling
- Sun exposure undoes the effect and can worsen darkening. Daily broad-spectrum sunscreen on treated skin is part of using it at all.
Common effects
- Redness, stinging, dryness and irritation.
- Contact dermatitis.
Serious effects
- Exogenous ochronosis, a permanent blue-black darkening of the treated skin, which is more common with prolonged use and on darker skin, and which is the outcome hydroquinone is meant to prevent.
- Unwanted lightening of the skin around the area treated.
Get medical help if
- Any blue, grey or black discoloration developing where you apply it. Stop and speak to the prescriber.
- Blistering, or severe swelling.
Tell your provider
- How long you have used hydroquinone in total, including from any other source. It is not intended for indefinite continuous use.
- Your skin tone, and any history of pigment changes.
Sources
- FDA warns consumers about skin-lightening products containing hydroquinone. US Food and Drug Administration. FDA consumer update and safety communication
Tretinoin
A topical retinoid approved on its own for acne vulgaris.
Not for
- Anyone who is pregnant, may become pregnant, or is trying to conceive, without discussing it with the prescriber first. Labeling states that safety in pregnancy has not been established.
- Use on sunburned, broken or eczematous skin.
Handling
- Tretinoin makes skin markedly more sensitive to sunlight. Daily broad-spectrum sunscreen and avoiding deliberate sun exposure are part of using it.
- Applied at night, to dry skin, because light and some other actives degrade it.
Common effects
- Redness, peeling, dryness, stinging and warmth, especially in the first weeks.
- An initial worsening of acne before it improves.
Serious effects
- Severe irritation, blistering or crusting.
- Marked darkening or lightening of treated skin.
Get medical help if
- Blistering, crusting, or severe swelling.
- Any suspicion that you are pregnant.
Tell your provider
- If you are pregnant, breastfeeding, or planning a pregnancy.
- Every other topical you use. Acids, benzoyl peroxide and scrubs stack irritation with it.
Sources
- Tretinoin topical prescribing information. US Food and Drug Administration. FDA-approved labeling
- Tretinoin topical prescribing information, Use in Specific Populations. US Food and Drug Administration. FDA-approved labeling
Spironolactone
A systemic drug approved for heart failure, high blood pressure and related conditions. It is not FDA-approved for acne or any skin condition, and not approved as a topical. How much is absorbed from a compounded cream has not been characterized.
Not for
- Anyone who is pregnant or may become pregnant. Labeling states spironolactone can cause fetal harm, and it is an antiandrogen.
- Anyone with high potassium, Addison's disease, or significant kidney impairment.
Handling
- Hormonally active cream can transfer by skin contact. Wash your hands and keep treated skin covered around others.
Common effects
- Irritation where applied.
- With systemic absorption: breast tenderness and menstrual changes.
Serious effects
- Hyperkalemia, high blood potassium, which can be fatal and may cause no symptoms until it is severe.
- Fetal harm in pregnancy.
Get medical help if
- Muscle weakness, a slow or irregular heartbeat, numbness or tingling.
- Confusion, or severe fatigue.
- Any suspicion that you are pregnant.
Tell your provider
- Any kidney problem, and any medicine that raises potassium, including ACE inhibitors, ARBs, potassium supplements and salt substitutes.
- Whether you could become pregnant, and what contraception you use.
Sources
- Spironolactone tablets prescribing information. US Food and Drug Administration. FDA-approved labeling
- Spironolactone tablets prescribing information, Warnings and Precautions. US Food and Drug Administration. FDA-approved labeling
Metformin
A systemic diabetes drug whose oral labeling carries a boxed warning for lactic acidosis. It is not FDA-approved for any skin condition and not approved as a topical; evidence for topical use in skin disease is preliminary.
Not for
- Anyone with significant kidney impairment, or with metabolic acidosis.
- Anyone who has reacted to metformin before.
Common effects
- Irritation where applied.
Serious effects
- Lactic acidosis is the risk the oral drug's boxed warning names. Whether a compounded topical delivers enough metformin to matter has not been established, which is itself the point: it has not been ruled out either.
Get medical help if
- Unusual muscle pain, trouble breathing, unusual sleepiness, stomach pain with nausea, or feeling cold and dizzy.
Tell your provider
- Any kidney or liver problem, and any heavy alcohol use.
- Whether you already take metformin by mouth.
Sources
- Metformin hydrochloride tablets prescribing information. US Food and Drug Administration. FDA-approved labeling
Progesterone
A hormone included in one compounded skin formulation. It is a systemic hormone, and absorption from a compounded cream has not been characterized.
Not for
- Anyone who is pregnant or may be pregnant, without discussing it with the prescriber.
- Anyone with undiagnosed abnormal genital bleeding, a history of breast cancer, or a clotting disorder.
Handling
- Hormone cream transfers by skin contact. Wash your hands and keep treated skin covered around children and other adults.
Common effects
- Irritation where applied.
- Breast tenderness, or changes in your cycle.
Serious effects
- Blood clots, where enough is absorbed systemically.
Get medical help if
- New, heavy or continuing vaginal bleeding.
- Chest pain, shortness of breath, or pain and swelling in one leg.
Tell your provider
- Any history of breast cancer, blood clots or liver disease.
- Any other hormone therapy you are taking.
Sources
- Progesterone capsules prescribing information. US Food and Drug Administration. FDA-approved labeling