OLOPATADINE HYDROCHLORIDE OPHTHALMIC

N/A

Manufactured by Bausch & Lomb Incorporated

6,325 FDA adverse event reports analyzed

Last updated: 2026-04-15

About OLOPATADINE HYDROCHLORIDE OPHTHALMIC

OLOPATADINE HYDROCHLORIDE OPHTHALMIC is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch & Lomb Incorporated. The most commonly reported adverse reactions for OLOPATADINE HYDROCHLORIDE OPHTHALMIC include TREATMENT FAILURE, DRUG INEFFECTIVE, HEADACHE, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OLOPATADINE HYDROCHLORIDE OPHTHALMIC.

Top Adverse Reactions

TREATMENT FAILURE1,933 reports
DRUG INEFFECTIVE226 reports
HEADACHE109 reports
NAUSEA109 reports
DIARRHOEA107 reports
PYREXIA101 reports
PNEUMONIA99 reports
FATIGUE98 reports
MALAISE93 reports
RASH87 reports
PAIN86 reports
DYSPNOEA79 reports
HYPERSENSITIVITY79 reports
PRURITUS78 reports
COUGH77 reports
ARTHRALGIA76 reports
SINUSITIS74 reports
DIZZINESS73 reports
PRODUCT DOSE OMISSION ISSUE69 reports
OFF LABEL USE67 reports
NASOPHARYNGITIS63 reports
VOMITING63 reports
ASTHMA56 reports
WEIGHT INCREASED54 reports
COVID 1952 reports
WEIGHT DECREASED48 reports
EYE PAIN47 reports
URINARY TRACT INFECTION47 reports
INFLUENZA46 reports
BRONCHITIS45 reports
DECREASED APPETITE45 reports
INSOMNIA45 reports
ANAEMIA44 reports
PAIN IN EXTREMITY44 reports
CONDITION AGGRAVATED43 reports
EYE IRRITATION43 reports
ASTHENIA41 reports
PLATELET COUNT DECREASED41 reports
BACK PAIN40 reports
ERYTHEMA39 reports
FALL39 reports
HEPATIC FUNCTION ABNORMAL39 reports
EYE PRURITUS38 reports
FEELING ABNORMAL37 reports
RENAL IMPAIRMENT36 reports
ILLNESS35 reports
INTERSTITIAL LUNG DISEASE34 reports
CONSTIPATION33 reports
DEATH33 reports
PRODUCTIVE COUGH33 reports
VISION BLURRED33 reports
HYPERTENSION32 reports
PRODUCT USE IN UNAPPROVED INDICATION32 reports
ANXIETY31 reports
DRY EYE31 reports
OCULAR HYPERAEMIA31 reports
RHINORRHOEA31 reports
URTICARIA31 reports
DRUG HYPERSENSITIVITY30 reports
FEBRILE NEUTROPENIA30 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION30 reports
WHITE BLOOD CELL COUNT DECREASED30 reports
PRODUCT USE ISSUE29 reports
CARDIAC DISORDER28 reports
DRUG ERUPTION28 reports
JOINT SWELLING28 reports
ABDOMINAL PAIN27 reports
BLOOD PRESSURE INCREASED27 reports
DEHYDRATION27 reports
INFUSION RELATED REACTION27 reports
BLOOD CHOLESTEROL INCREASED26 reports
CELLULITIS26 reports
HYPOTENSION26 reports
OEDEMA PERIPHERAL26 reports
OROPHARYNGEAL PAIN26 reports
SEPSIS26 reports
BLOOD PRESSURE DECREASED25 reports
BLOOD PRESSURE FLUCTUATION25 reports
GAIT DISTURBANCE25 reports
INJECTION SITE PAIN25 reports
MUSCLE SPASMS25 reports
CARDIAC FAILURE24 reports
CHEST PAIN24 reports
HEART RATE INCREASED24 reports
PERIPHERAL SWELLING24 reports
PRODUCT DELIVERY MECHANISM ISSUE24 reports
HERPES ZOSTER23 reports
NASAL CONGESTION23 reports
NEUTROPHIL COUNT DECREASED23 reports
NO ADVERSE EVENT23 reports
SEASONAL ALLERGY23 reports
VIRAL INFECTION23 reports
CHEST DISCOMFORT22 reports
CONJUNCTIVITIS22 reports
ABDOMINAL PAIN UPPER21 reports
DEPRESSION21 reports
DRY SKIN21 reports
HYPOAESTHESIA21 reports
INFLUENZA LIKE ILLNESS21 reports
LIVER DISORDER21 reports

Report Outcomes

Out of 3,854 classified reports for OLOPATADINE HYDROCHLORIDE OPHTHALMIC:

Serious 33.3%Non-Serious 66.7%

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

Female2,512 (68.1%)
Male1,174 (31.8%)
Unknown2 (0.1%)

Reports by Age

Age 7438 reports
Age 5237 reports
Age 6836 reports
Age 6335 reports
Age 7231 reports
Age 6130 reports
Age 5528 reports
Age 6028 reports
Age 6528 reports
Age 5627 reports
Age 6627 reports
Age 7727 reports
Age 4926 reports
Age 6724 reports
Age 6924 reports
Age 7024 reports
Age 7524 reports
Age 5323 reports
Age 5823 reports
Age 7123 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 OLOPATADINE HYDROCHLORIDE OPHTHALMIC?

This profile reflects 6,325 FDA FAERS reports that mention OLOPATADINE HYDROCHLORIDE OPHTHALMIC. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OLOPATADINE HYDROCHLORIDE OPHTHALMIC?

Frequently reported terms in FAERS include TREATMENT FAILURE, DRUG INEFFECTIVE, HEADACHE, NAUSEA, DIARRHOEA, PYREXIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OLOPATADINE HYDROCHLORIDE OPHTHALMIC?

Labeling and FAERS entries often list Bausch & Lomb Incorporated in connection with OLOPATADINE HYDROCHLORIDE OPHTHALMIC. 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.