Brand name · Fluocinolone acetonide, hydroquinone, and tretinoin
Tri-Luma: adverse event reports filed with FDA
502 reports list it as a suspect or interacting product, 2006–2026. Class: Corticosteroid.
- 502
- reports as suspect product
- 0% of all reports · about 25 a year
- 24
- reports, 12 months to June 2026
- 13 in the 12 months before
- 4.2%
- marked serious by the reporter
- 77.7% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
502 adverse event reports received by FDA list the brand name Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) as a suspect or interacting product, from February 2006 to June 2026. A further 33 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 24 reports listed it, up 85% from 13 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 25 reports a year and 0% of the 20,646,523 reports in the database, and 0.1% of the reports for the corticosteroid class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are erythema (31.5%), drug ineffective (24.1%) and skin burning sensation (17.3%). A report can list several reactions, so shares add to more than 100%; 93 different terms appear across these reports. Erythema is recorded in 31.5% of these reports, a larger share than in the median corticosteroid drug (0.8%).
4.2% of the reports are marked serious by the reporter (77.7% across the class); 0% record death among the outcomes and 0.2% record hospitalisation, as reported. 86.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (27.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Tri-Luma reports recording the termmedian drug in corticosteroid
- Erythemaskin redness31.5%158
- Drug ineffectivethe medicine did not work as expected24.1%121
- Skin burning sensationburning skin17.3%87
- Condition aggravatedthe condition being treated got worse13.5%68
- Skin exfoliationpeeling skin12.5%63
- Product use issuea problem in how the product was used10%50
- Dry skindry skin9.8%49
- Intentional product use issuedeliberate use not as intended9.6%48
- Intentional product misusedeliberate use not as intended9.2%46
- Pruritusitching9.2%46
- Skin irritationirritated skin9.2%46
- Skin hyperpigmentation8.8%44
- Incorrect product storagethe product was stored wrongly8.4%42
- Product use in unapproved indicationused for a purpose not on the label7.2%36
- Rashskin rash6.8%34
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times6%30
- Pain of skin5.4%27
- Product storage errorthe product was stored wrongly3.8%19
- Rash papular3.8%19
- Off label useused for a purpose or in a way not on the label2.8%14
- Skin discolourationa change in skin colour2.8%14
- Drug effect decreasedthe medicine had less effect2.6%13
- Blistera blister2.4%12
- Dermatitisinflamed skin2.4%12
- Hypersensitivityan allergic-type reaction2.4%12
- Application site erythemaredness where the product was applied2.2%11
- Skin hypopigmentation2.2%11
- Inappropriate schedule of product administrationthe product was taken at the wrong times2%10
Top 30 of 93 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 74 drugs in the corticosteroid class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 808,789 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 98.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Chloasma | 135 | 26.9% |
| Skin hyperpigmentation | 77 | 15.3% |
| Pigmentation disorder | 70 | 13.9% |
| Solar lentigo | 21 | 4.2% |
| Skin discolouration | 20 | 4% |
| Lentigo | 9 | 1.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 502 reports.
In context
| Measure | Tri-Luma | Corticosteroid | All reports |
|---|---|---|---|
| Reports as suspect product | 502 | 808,789 | 20,646,523 |
| Share of that pool | — | 0.1% | 0% |
| Reports, latest 12 months | 24 | — | 1,332,454 |
| Marked serious | 4.2% | 77.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 146 | 91 |
| Hospitalisation recorded, per 1,000 reports | 2 | 336 | 213 |
| Consumer-filed share | 86.3% | 29.1% | 45.8% |
| Top term, share of reports | Erythema 31.5% | median 0.8% | 1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the corticosteroid class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Prednisone | generic | 183,867 | 15,614 | 91.4% |
| Dexamethasone | generic | 129,677 | 9,216 | 95.1% |
| Prednisolone | generic | 87,806 | 6,624 | 97.6% |
| Methylprednisolone | generic | 49,537 | 4,430 | 95.2% |
| Symbicort | brand | 39,119 | 1,177 | 50.6% |
| Breo Ellipta | brand | 22,220 | 628 | 31.7% |
| Hydrocortisone | generic | 21,263 | 2,386 | 89.5% |
| Advair Diskus | brand | 20,518 | 120 | 29% |
| Advair Hfa | brand | 19,622 | 589 | 54.9% |
| Budesonide | generic | 14,714 | 1,083 | 82.2% |
| Desoximetasone | generic | 12,209 | 1,525 | 99.2% |
| Flovent | brand | 10,772 | 171 | 42.1% |
| Methylprednisolone sodium succinate | generic | 10,772 | 1,630 | 97.8% |
| Solu-medrol | generic | 10,288 | 432 | 88.8% |
| Cipro | brand | 9,791 | 108 | 57.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Tri-Luma reports
How many adverse event reports has FDA received for Tri-Luma?
502 reports list Tri-Luma as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 24 of them arrived in the latest 12 months. Another 33 list it only as a concomitant medication.
What reactions are recorded in Tri-Luma reports?
erythema (31.5%), drug ineffective (24.1%), skin burning sensation (17.3%), condition aggravated (13.5%) and skin exfoliation (12.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Tri-Luma was responsible.
How serious are the reports?
4.2% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (86.3%), other health professional (5.4%) and pharmacist (3.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Tri-Luma rising?
24 reports in the 12 months to June 2026, up 85% from 13 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Tri-Luma was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Tri-Luma?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Tri-Luma as a suspect or interacting product; reports listing it only as a concomitant medication (33) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.