LOTEPREDNOL ETABONATE

N/A

Manufactured by Bausch & Lomb Incorporated

11,509 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LOTEPREDNOL ETABONATE

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

Top Adverse Reactions

EYE PAIN718 reports
EYE IRRITATION607 reports
OFF LABEL USE462 reports
DRUG INEFFECTIVE414 reports
VISION BLURRED405 reports
OCULAR HYPERAEMIA353 reports
HEADACHE278 reports
FATIGUE244 reports
DRY EYE226 reports
NAUSEA205 reports
PAIN202 reports
PRODUCT DOSE OMISSION ISSUE194 reports
LACRIMATION INCREASED185 reports
VISUAL IMPAIRMENT183 reports
PRODUCT USE IN UNAPPROVED INDICATION182 reports
EYE SWELLING172 reports
PHOTOPHOBIA167 reports
EYE PRURITUS164 reports
DIZZINESS162 reports
RASH158 reports
CONDITION AGGRAVATED156 reports
DYSPNOEA143 reports
DIARRHOEA142 reports
OCULAR DISCOMFORT142 reports
PRURITUS134 reports
INTRAOCULAR PRESSURE INCREASED133 reports
FOREIGN BODY SENSATION IN EYES132 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS111 reports
ANXIETY108 reports
CATARACT108 reports
EYE DISCHARGE105 reports
FALL105 reports
ARTHRALGIA104 reports
INSOMNIA101 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION100 reports
MALAISE98 reports
ASTHENIA94 reports
HYPERSENSITIVITY89 reports
CHRONIC KIDNEY DISEASE88 reports
NASOPHARYNGITIS87 reports
EYE INFLAMMATION86 reports
COUGH85 reports
WEIGHT DECREASED85 reports
BACK PAIN83 reports
PRODUCT QUALITY ISSUE83 reports
DRUG HYPERSENSITIVITY81 reports
VOMITING81 reports
PNEUMONIA80 reports
EYE DISORDER79 reports
PAIN IN EXTREMITY76 reports
DEATH75 reports
HYPERTENSION74 reports
BLOOD PRESSURE INCREASED73 reports
ERYTHEMA73 reports
RENAL FAILURE72 reports
DEPRESSION71 reports
PRODUCT USE ISSUE69 reports
VISUAL ACUITY REDUCED68 reports
EYELID PAIN66 reports
ALOPECIA64 reports
URINARY TRACT INFECTION64 reports
GLAUCOMA63 reports
PYREXIA62 reports
FEELING ABNORMAL61 reports
OROPHARYNGEAL PAIN61 reports
DECREASED APPETITE60 reports
THERAPY INTERRUPTED60 reports
ACUTE KIDNEY INJURY58 reports
CONSTIPATION58 reports
INTENTIONAL PRODUCT USE ISSUE57 reports
CHEST PAIN56 reports
COVID 1956 reports
SINUSITIS55 reports
EYE INFECTION53 reports
MUSCLE SPASMS53 reports
WEIGHT INCREASED50 reports
ABDOMINAL PAIN UPPER49 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION49 reports
INSTILLATION SITE PAIN49 reports
SWELLING OF EYELID49 reports
BURNING SENSATION48 reports
INJECTION SITE PAIN48 reports
PRODUCT ADMINISTRATION ERROR48 reports
URTICARIA48 reports
DRUG DOSE OMISSION47 reports
SOMNOLENCE47 reports
ABDOMINAL PAIN46 reports
HYPOAESTHESIA46 reports
INCORRECT DOSE ADMINISTERED46 reports
ANAEMIA45 reports
PRODUCT PRESCRIBING ERROR45 reports
ABDOMINAL DISCOMFORT44 reports
EMOTIONAL DISTRESS44 reports
INFECTION44 reports
PERIORBITAL PAIN44 reports
RHINORRHOEA44 reports
GAIT DISTURBANCE42 reports
PARAESTHESIA42 reports
PRODUCT PRESCRIBING ISSUE42 reports
MEMORY IMPAIRMENT41 reports

Report Outcomes

Out of 5,375 classified reports for LOTEPREDNOL ETABONATE:

Serious 33.9%Non-Serious 66.1%

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

Female3,825 (74.6%)
Male1,277 (24.9%)
Unknown24 (0.5%)

Reports by Age

Age 69102 reports
Age 7689 reports
Age 7088 reports
Age 6786 reports
Age 6585 reports
Age 6084 reports
Age 6884 reports
Age 7583 reports
Age 7280 reports
Age 6478 reports
Age 6377 reports
Age 7377 reports
Age 7476 reports
Age 7175 reports
Age 6170 reports
Age 6269 reports
Age 7767 reports
Age 6666 reports
Age 5765 reports
Age 5562 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 LOTEPREDNOL ETABONATE?

This profile reflects 11,509 FDA FAERS reports that mention LOTEPREDNOL ETABONATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LOTEPREDNOL ETABONATE?

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

Who manufactures LOTEPREDNOL ETABONATE?

Labeling and FAERS entries often list Bausch & Lomb Incorporated in connection with LOTEPREDNOL ETABONATE. 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.