PROPARACAINE HYDROCHLORIDE

N/A

Manufactured by Alcon Laboratories, Inc.

1,545 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PROPARACAINE HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alcon Laboratories, Inc.. The most commonly reported adverse reactions for PROPARACAINE HYDROCHLORIDE include OFF LABEL USE, CONJUNCTIVAL HYPERAEMIA, EYE PAIN, DRUG ABUSE, CORNEAL OEDEMA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROPARACAINE HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE89 reports
CONJUNCTIVAL HYPERAEMIA65 reports
EYE PAIN61 reports
DRUG ABUSE59 reports
CORNEAL OEDEMA54 reports
HYPOPYON52 reports
CORNEAL EPITHELIUM DEFECT42 reports
VISION BLURRED42 reports
ULCERATIVE KERATITIS36 reports
PHOTOPHOBIA33 reports
VISUAL ACUITY REDUCED33 reports
KERATOPATHY32 reports
ENDOPHTHALMITIS28 reports
LACRIMATION INCREASED27 reports
CORNEAL INFILTRATES25 reports
PERSISTENT CORNEAL EPITHELIAL DEFECT24 reports
INTENTIONAL PRODUCT USE ISSUE21 reports
APNOEA20 reports
EYE INFLAMMATION20 reports
VOMITING20 reports
CORNEAL OPACITY19 reports
TOXIC ANTERIOR SEGMENT SYNDROME19 reports
CATARACT18 reports
VISUAL IMPAIRMENT18 reports
ABDOMINAL DISTENSION17 reports
CILIARY HYPERAEMIA16 reports
FEEDING INTOLERANCE16 reports
GASTRIC RESIDUAL INCREASED16 reports
PRODUCT USE IN UNAPPROVED INDICATION16 reports
EYE IRRITATION15 reports
HYPONATRAEMIA15 reports
VITRITIS15 reports
EYELID OEDEMA14 reports
INTRAOCULAR PRESSURE INCREASED13 reports
NAUSEA13 reports
OCULAR HYPERAEMIA13 reports
RETINAL HAEMORRHAGE13 reports
ANTERIOR CHAMBER CELL12 reports
INTENTIONAL PRODUCT MISUSE12 reports
ANTERIOR CHAMBER INFLAMMATION11 reports
DIZZINESS11 reports
PUNCTATE KERATITIS11 reports
TRANSMISSION OF AN INFECTIOUS AGENT VIA PRODUCT11 reports
VITREOUS HAEMORRHAGE11 reports
DISEASE RECURRENCE10 reports
HYPERSENSITIVITY10 reports
HYPERTENSION10 reports
LOSS OF CONSCIOUSNESS10 reports
POST PROCEDURAL COMPLICATION10 reports
PRODUCT CONTAMINATION MICROBIAL10 reports
RETINOPATHY OF PREMATURITY10 reports
ACUTE MYOCARDIAL INFARCTION9 reports
CORNEAL THINNING9 reports
DRY EYE9 reports
DYSPNOEA9 reports
HEADACHE9 reports
MACULAR OEDEMA9 reports
PAIN9 reports
PRODUCT QUALITY ISSUE9 reports
RETINAL DISORDER9 reports
RETINAL OEDEMA9 reports
SYNCOPE9 reports
BACTERIAL ENDOPHTHALMITIS8 reports
BLEPHAROSPASM8 reports
CEREBROVASCULAR ACCIDENT8 reports
CONJUNCTIVAL OEDEMA8 reports
ERYTHEMA OF EYELID8 reports
KERATITIS8 reports
RETINAL PIGMENT EPITHELIAL TEAR8 reports
VITREOUS DETACHMENT8 reports
ANXIETY7 reports
BLOOD SODIUM DECREASED7 reports
CORNEAL LEUKOMA7 reports
DRUG INEFFECTIVE7 reports
GLAUCOMA7 reports
MYDRIASIS7 reports
OCULAR HYPERTENSION7 reports
TOXICITY TO VARIOUS AGENTS7 reports
ANGIOGRAM RETINA ABNORMAL6 reports
BLINDNESS6 reports
BLINDNESS UNILATERAL6 reports
BLOOD CHLORIDE DECREASED6 reports
BLOOD PRESSURE DECREASED6 reports
CHEST DISCOMFORT6 reports
CHEST PAIN6 reports
CORNEAL EROSION6 reports
CORNEAL SCAR6 reports
DEATH6 reports
DRUG HYPERSENSITIVITY6 reports
FALL6 reports
FATIGUE6 reports
HYPERHIDROSIS6 reports
PRODUCT USE ISSUE6 reports
RETINAL DETACHMENT6 reports
TREMOR6 reports
VITREOUS FLOATERS6 reports
ANTERIOR CHAMBER FIBRIN5 reports
BACK PAIN5 reports
CONDITION AGGRAVATED5 reports
CONJUNCTIVITIS5 reports

Report Outcomes

Out of 505 classified reports for PROPARACAINE HYDROCHLORIDE:

Serious 91.9%Non-Serious 8.1%

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

Female199 (53.6%)
Male168 (45.3%)
Unknown4 (1.1%)

Reports by Age

Age 8019 reports
Age 2812 reports
Age 3811 reports
Age 369 reports
Age 699 reports
Age 648 reports
Age 728 reports
Age 738 reports
Age 818 reports
Age 297 reports
Age 307 reports
Age 507 reports
Age 547 reports
Age 587 reports
Age 416 reports
Age 456 reports
Age 566 reports
Age 656 reports
Age 666 reports
Age 706 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 PROPARACAINE HYDROCHLORIDE?

This profile reflects 1,545 FDA FAERS reports that mention PROPARACAINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PROPARACAINE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, CONJUNCTIVAL HYPERAEMIA, EYE PAIN, DRUG ABUSE, CORNEAL OEDEMA, HYPOPYON. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PROPARACAINE HYDROCHLORIDE?

Labeling and FAERS entries often list Alcon Laboratories, Inc. in connection with PROPARACAINE HYDROCHLORIDE. 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.