What the label lists and what reports show
Fluocinolone and hydroquinone and tretinoin side effects
Fluocinolone and hydroquinone and tretinoin's FDA label: “The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application.” FAERS holds 544 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is erythema (161 reports).
- No generic listed
Check it at the source: the fluocinolone and hydroquinone and tretinoin FDA label on DailyMed (effective October 24, 2024, Galderma Laboratories, L.P.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TRI-LUMA Cream?TRI-LUMA Cream may cause serious side effects, including: allergic reactions. TRI-LUMA Cream may cause allergic reactions that can be life threatening. Stop using TRI-LUMA Cream and call your doctor to get medical help right away if you get any of the following symptoms: swelling of your face, eyes, lips, tongue, or throat trouble breathing severe itching skin rash or hives change in skin color. One of the medicines in TRI-LUMA Cream can cause a blue-black darkening of your skin. Stop using TRI-LUMA Cream and tell your doctor if you develop a blue-black darkening of your skin. • TRI-LUMA Cream can pass through your skin. Too much TRI-LUMA Cream passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems. skin irritation. […]
Source: FDA drug label, Galderma Laboratories, L.P., effective October 24, 2024 (SPL set a35fa709-5eb5-4429-b38f-f1e0019bf0ee), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Event | Table 1. Incidence and Frequency of Treatment-related Adverse Events with TRI-LUMA Cream… n (%) |
|---|---|
| Erythema | 66 (41%) |
| Desquamation | 61 (38%) |
| Burning | 29 (18%) |
| Dryness | 23 (14%) |
| Pruritus | 18 (11%) |
| Acne | 8 (5%) |
| Paresthesia | 5 (3%) |
| Telangiectasia | 5 (3%) |
| Hyperesthesia | 3 (2%) |
| Pigmentary changes | 3 (2%) |
| Irritation | 3 (2%) |
| Papules | 2 (1%) |
| Acne-like rash | 1 (1%) |
| Rosacea | 1 (1%) |
| Dry Mouth | 1 (1%) |
| Rash | 1 (1%) |
| Vesicles | 1 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedBecause clinical trials are conducted under widely varying conditions, adverse reaction rates 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 controlled clinical trials, adverse events were monitored in the 161 subjects who used TRI-LUMA Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity. Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with TRI-LUMA Cream from the controlled clinical trials are summarized (in decreasing order of frequency) as follows: Table 1. …
Source: FDA drug label, Galderma Laboratories, L.P., effective October 24, 2024 (SPL set a35fa709-5eb5-4429-b38f-f1e0019bf0ee), via openFDA; the full label on DailyMed
What do FAERS reports show?
544 reports list fluocinolone and hydroquinone and tretinoin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fluocinolone and hydroquinone and tretinoin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions