FLUOCINOLONE ACETONIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

6,482 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for FLUOCINOLONE ACETONIDE include OFF LABEL USE, DRUG INEFFECTIVE, PRURITUS, INTRAOCULAR PRESSURE INCREASED, PRODUCT DOSE OMISSION ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUOCINOLONE ACETONIDE.

Top Adverse Reactions

OFF LABEL USE584 reports
DRUG INEFFECTIVE242 reports
PRURITUS202 reports
INTRAOCULAR PRESSURE INCREASED200 reports
PRODUCT DOSE OMISSION ISSUE200 reports
RASH157 reports
DEVICE DISLOCATION152 reports
DEVICE FAILURE150 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR141 reports
NO ADVERSE EVENT132 reports
DIARRHOEA129 reports
PSORIASIS126 reports
HEADACHE117 reports
FATIGUE116 reports
PAIN115 reports
MEDICAL DEVICE REMOVAL103 reports
NEEDLE ISSUE97 reports
NAUSEA96 reports
CONDITION AGGRAVATED90 reports
ARTHRALGIA82 reports
VISUAL IMPAIRMENT75 reports
DERMATITIS ATOPIC74 reports
DIZZINESS72 reports
SKIN EXFOLIATION72 reports
PRODUCT ADMINISTRATION ERROR70 reports
PRODUCT USE IN UNAPPROVED INDICATION68 reports
DRY SKIN66 reports
ALOPECIA65 reports
ERYTHEMA65 reports
PAIN IN EXTREMITY61 reports
GLAUCOMA59 reports
VOMITING59 reports
PRODUCT QUALITY ISSUE58 reports
VITRECTOMY56 reports
COUGH53 reports
CORNEAL OEDEMA52 reports
CATARACT51 reports
DISCOMFORT50 reports
DYSPNOEA48 reports
MALAISE48 reports
INJECTION SITE PAIN47 reports
ECZEMA46 reports
SLEEP DISORDER46 reports
WEIGHT DECREASED46 reports
EYE PAIN45 reports
PNEUMONIA45 reports
ABDOMINAL PAIN UPPER44 reports
BLINDNESS43 reports
DRUG DELIVERY SYSTEM ISSUE43 reports
ASTHENIA41 reports
BACK PAIN41 reports
INSOMNIA41 reports
HYPOTONY OF EYE40 reports
PYREXIA40 reports
VISUAL ACUITY REDUCED40 reports
ANXIETY39 reports
URTICARIA39 reports
CATARACT OPERATION38 reports
FALL37 reports
NASOPHARYNGITIS37 reports
DEPRESSION36 reports
HYPERSENSITIVITY36 reports
VISION BLURRED36 reports
CONSTIPATION35 reports
DEVICE ISSUE35 reports
DRUG DOSE OMISSION BY DEVICE35 reports
COVID 1934 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION34 reports
INFECTION34 reports
SKIN DISCOLOURATION34 reports
URINARY TRACT INFECTION33 reports
VITREOUS HAEMORRHAGE33 reports
COMPLICATION OF DEVICE INSERTION32 reports
DEVICE DIFFICULT TO USE32 reports
HYPERTENSION32 reports
PERIPHERAL SWELLING31 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION31 reports
ENDOPHTHALMITIS30 reports
MIGRAINE30 reports
PRODUCT USE ISSUE30 reports
SWELLING30 reports
MACULAR OEDEMA29 reports
ABDOMINAL DISCOMFORT28 reports
DECREASED APPETITE28 reports
FEELING ABNORMAL28 reports
THERAPEUTIC RESPONSE DECREASED28 reports
WEIGHT INCREASED28 reports
ABDOMINAL PAIN27 reports
IMPLANTATION COMPLICATION27 reports
MYALGIA27 reports
DRUG DELIVERY SYSTEM MALFUNCTION26 reports
GAIT DISTURBANCE26 reports
MUSCLE SPASMS26 reports
THERAPY NON RESPONDER25 reports
VITREOUS FLOATERS25 reports
ACNE24 reports
BRONCHITIS24 reports
BURNING SENSATION24 reports
OCULAR HYPERTENSION24 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE24 reports

Report Outcomes

Out of 3,575 classified reports for FLUOCINOLONE ACETONIDE:

Serious 40.6%Non-Serious 59.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female1,776 (60.9%)
Male1,136 (39.0%)
Unknown3 (0.1%)

Reports by Age

Age 6359 reports
Age 6158 reports
Age 5952 reports
Age 6652 reports
Age 6446 reports
Age 7243 reports
Age 5742 reports
Age 6742 reports
Age 6941 reports
Age 7141 reports
Age 6038 reports
Age 6537 reports
Age 7337 reports
Age 6235 reports
Age 6835 reports
Age 7534 reports
Age 5333 reports
Age 5433 reports
Age 5833 reports
Age 7433 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FLUOCINOLONE ACETONIDE?

This profile reflects 6,482 FDA FAERS reports that mention FLUOCINOLONE ACETONIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FLUOCINOLONE ACETONIDE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, PRURITUS, INTRAOCULAR PRESSURE INCREASED, PRODUCT DOSE OMISSION ISSUE, RASH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FLUOCINOLONE ACETONIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with FLUOCINOLONE ACETONIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.