OpenClaim

Fluocinolone Side Effects

The most commonly reported side effects of fluocinolone include off label use, pruritus, and erythema, based on 5,775 FDA adverse event reports from 2004 to 2025. 9.5% of reports found the drug to be ineffective.

Fluocinolone side effects

Percentages show how often each reaction appears relative to total reports for fluocinolone.

1
Off Label Use11.8%684
2
Drug Ineffective9.5%548
3
Pruritus6.1%350
4
Erythema4.7%274
5
Psoriasis4.4%254
6
Rash4.3%251
7
Product Dose Omission Issue4.2%243
8
Intraocular Pressure Increased3.5%200
9
Pain3.4%198
10
Condition Aggravated3.3%193
11
Headache3.3%190
12
Diarrhoea3.3%189
13
Skin Exfoliation3.1%180
14
Fatigue3.1%180
15
Product Use In Unapproved Indication2.9%168

These are voluntary reports and do not establish that fluocinolone caused these reactions.

Report severity

39.8%Serious2,299 reports
12.9%Hospitalizations746 reports
2.3%Fatal131 reports

Seriousness is determined by the reporter, not by OpenClaim.

Fluocinolone drug interactions

Other drugs that appear in adverse event reports alongside fluocinolone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab9.6%553
2
Tretinoin8.6%498
3
Hydroquinone8.5%490
4
Apremilast4.4%252
5
Adalimumab2.7%154
6
Clobetasol-propionate2.6%149
7
Methotrexate2.5%143
8
Secukinumab2.5%143
9
Triamcinolone2.4%139
10
Ciprofloxacin2.0%116
11
Lenalidomide1.7%97
12
Etanercept1.6%93
13
Sodium-oxybate1.6%93
14
Cyclosporine1.5%88
15
Hydrocortisone1.5%85

Taken alongside

1
Triamcinolone11.5%665
2
Ergocalciferol10.9%628
3
Acetaminophen10.4%599
4
Clobetasol-propionate10.1%586
5
Fluticasone9.4%545
6
Albuterol9.2%529
7
Aspirin8.3%477
8
Levothyroxine-sodium7.7%445
9
Prednisone7.4%426
10
Omeprazole6.9%397
11
Atorvastatin-calcium6.1%355
12
Hydrocortisone6.0%348
13
Gabapentin5.7%327
14
Amlodipine5.6%325
15
Cetirizine-hydrochloride5.6%324

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports fluocinolone side effects

56.4% of fluocinolone adverse event reports involve female patients and 28.4% involve male patients. The largest age group is adult at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.4%
Male28.4%
Unknown15.2%

Age group

< 21.1%
2–114.7%
12–173.8%
18–6458.0%
65+32.4%

What is fluocinolone used for

Conditions and purposes for which patients were taking fluocinolone when the adverse event was reported.

Acanthosis NigricansAcneAcute Zonal Occult Outer RetinopathyAlcoholismAlopeciaAlopecia AreataAnaemiaAnalgesic TherapyAntibiotic ProphylaxisAntibiotic TherapyAntiinflammatory TherapyApplication Site ExfoliationApplication Site PruritusApplication Site SwellingArthritis

Showing 15 of 350 indications

Fluocinolone brand names and reporting trend

Fluocinolone is sold under the brand name Tri-luma.

Brand names

Tri-luma3,055

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking fluocinolone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.