PREDNISOLONE ACETATE

N/A

Manufactured by Allergan, Inc.

16,640 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PREDNISOLONE ACETATE

PREDNISOLONE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. The most commonly reported adverse reactions for PREDNISOLONE ACETATE include TREATMENT FAILURE, DRUG INEFFECTIVE, EYE PAIN, OFF LABEL USE, VISION BLURRED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PREDNISOLONE ACETATE.

Top Adverse Reactions

TREATMENT FAILURE1,259 reports
DRUG INEFFECTIVE902 reports
EYE PAIN713 reports
OFF LABEL USE633 reports
VISION BLURRED398 reports
EYE IRRITATION385 reports
FATIGUE360 reports
HEADACHE354 reports
OCULAR HYPERAEMIA299 reports
DIARRHOEA285 reports
CATARACT268 reports
CONDITION AGGRAVATED262 reports
PAIN262 reports
NAUSEA250 reports
DYSPNOEA247 reports
INTRAOCULAR PRESSURE INCREASED242 reports
VISUAL IMPAIRMENT228 reports
DIZZINESS218 reports
PNEUMONIA213 reports
PYREXIA211 reports
VISUAL ACUITY REDUCED208 reports
RASH201 reports
ARTHRALGIA199 reports
PRODUCT DOSE OMISSION ISSUE199 reports
ENDOPHTHALMITIS180 reports
PHOTOPHOBIA163 reports
ASTHENIA161 reports
FALL159 reports
PRURITUS158 reports
NO ADVERSE EVENT152 reports
WEIGHT DECREASED150 reports
EYE SWELLING149 reports
COUGH147 reports
UVEITIS145 reports
DEATH141 reports
VOMITING140 reports
HYPERTENSION139 reports
MALAISE139 reports
DRY EYE138 reports
HYPERSENSITIVITY136 reports
LACRIMATION INCREASED132 reports
DECREASED APPETITE131 reports
PAIN IN EXTREMITY131 reports
URINARY TRACT INFECTION130 reports
GLAUCOMA129 reports
PRODUCT USE IN UNAPPROVED INDICATION122 reports
PRODUCT USE ISSUE120 reports
BACK PAIN118 reports
RENAL FAILURE118 reports
BLINDNESS115 reports
EYE INFLAMMATION110 reports
INFECTION109 reports
ACUTE KIDNEY INJURY106 reports
OCULAR DISCOMFORT106 reports
CONSTIPATION104 reports
NASOPHARYNGITIS104 reports
SINUSITIS104 reports
INSOMNIA103 reports
FOREIGN BODY SENSATION IN EYES102 reports
EYE DISORDER101 reports
ANXIETY97 reports
BLOOD PRESSURE INCREASED95 reports
HYPOTENSION93 reports
WEIGHT INCREASED92 reports
CHRONIC KIDNEY DISEASE91 reports
CORNEAL OEDEMA91 reports
COVID 1991 reports
MUSCLE SPASMS88 reports
ABDOMINAL DISCOMFORT87 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS85 reports
ABDOMINAL PAIN84 reports
PRODUCT QUALITY ISSUE83 reports
DEPRESSION82 reports
EYE DISCHARGE82 reports
SEPSIS82 reports
JOINT SWELLING81 reports
GAIT DISTURBANCE80 reports
OEDEMA PERIPHERAL79 reports
PERIPHERAL SWELLING78 reports
PLATELET COUNT DECREASED78 reports
BLOOD GLUCOSE INCREASED76 reports
EYE PRURITUS76 reports
ALOPECIA75 reports
ANAEMIA75 reports
BLINDNESS UNILATERAL75 reports
DRUG HYPERSENSITIVITY75 reports
INCORRECT DOSE ADMINISTERED75 reports
ABDOMINAL PAIN UPPER74 reports
CHEST PAIN74 reports
ATRIAL FIBRILLATION72 reports
ERYTHEMA71 reports
HYPOAESTHESIA70 reports
IMPAIRED HEALING70 reports
HAEMOGLOBIN DECREASED69 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION69 reports
MUSCULAR WEAKNESS69 reports
WHITE BLOOD CELL COUNT DECREASED69 reports
FEBRILE NEUTROPENIA68 reports
TREMOR66 reports
PARAESTHESIA65 reports

Report Outcomes

Out of 9,862 classified reports for PREDNISOLONE ACETATE:

Serious 51.8%Non-Serious 48.2%

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

Female5,395 (60.1%)
Male3,542 (39.5%)
Unknown35 (0.4%)

Reports by Age

Age 68155 reports
Age 70147 reports
Age 71139 reports
Age 66137 reports
Age 72133 reports
Age 74131 reports
Age 76130 reports
Age 63123 reports
Age 64123 reports
Age 67117 reports
Age 75115 reports
Age 73114 reports
Age 78112 reports
Age 62109 reports
Age 65106 reports
Age 69105 reports
Age 59103 reports
Age 58101 reports
Age 6198 reports
Age 7798 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 PREDNISOLONE ACETATE?

This profile reflects 16,640 FDA FAERS reports that mention PREDNISOLONE ACETATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PREDNISOLONE ACETATE?

Frequently reported terms in FAERS include TREATMENT FAILURE, DRUG INEFFECTIVE, EYE PAIN, OFF LABEL USE, VISION BLURRED, EYE IRRITATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PREDNISOLONE ACETATE?

Labeling and FAERS entries often list Allergan, Inc. in connection with PREDNISOLONE ACETATE. 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.