TETRACAINE

N/A

Manufactured by Bellus Medical, LLC

876 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TETRACAINE

TETRACAINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bellus Medical, LLC. The most commonly reported adverse reactions for TETRACAINE include OFF LABEL USE, ENDOPHTHALMITIS, INFLAMMATION, VISION BLURRED, CORNEAL EPITHELIUM DEFECT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TETRACAINE.

Top Adverse Reactions

OFF LABEL USE46 reports
ENDOPHTHALMITIS32 reports
INFLAMMATION24 reports
VISION BLURRED24 reports
CORNEAL EPITHELIUM DEFECT22 reports
TOXIC ANTERIOR SEGMENT SYNDROME20 reports
VISUAL IMPAIRMENT19 reports
DRUG HYPERSENSITIVITY18 reports
EYE PAIN18 reports
HEADACHE18 reports
VISUAL ACUITY REDUCED18 reports
EYE DISORDER17 reports
SUSPECTED TRANSMISSION OF AN INFECTIOUS AGENT VIA PRODUCT16 reports
DEATH15 reports
EYE IRRITATION15 reports
OCULAR HYPERAEMIA15 reports
EYE INFLAMMATION13 reports
HYPOPYON13 reports
FATIGUE12 reports
BLINDNESS11 reports
PAIN11 reports
PRURITUS11 reports
CATARACT10 reports
NAUSEA10 reports
VITREOUS FLOATERS10 reports
CORNEAL OEDEMA9 reports
DYSPNOEA9 reports
ERYTHEMA9 reports
EYE OEDEMA9 reports
HYPOTENSION9 reports
OVERDOSE9 reports
DERMATITIS CONTACT8 reports
DRUG INEFFECTIVE8 reports
HYPERSENSITIVITY8 reports
MUSCLE SPASMS8 reports
PHOTOPHOBIA8 reports
SEIZURE8 reports
TOXICITY TO VARIOUS AGENTS8 reports
VITREOUS DETACHMENT8 reports
ACUTE KIDNEY INJURY7 reports
ANXIETY7 reports
CORNEAL INFILTRATES7 reports
CORNEAL OPACITY7 reports
DIZZINESS7 reports
DYSKINESIA7 reports
HYPOXIA7 reports
RENAL FAILURE7 reports
STRESS CARDIOMYOPATHY7 reports
BACTERIAL ENDOPHTHALMITIS6 reports
BLINDNESS UNILATERAL6 reports
DIARRHOEA6 reports
ELECTROCARDIOGRAM T WAVE INVERSION6 reports
HYPOAESTHESIA6 reports
INSOMNIA6 reports
MENTAL STATUS CHANGES6 reports
PRODUCT USE IN UNAPPROVED INDICATION6 reports
PRODUCT USE ISSUE6 reports
PULMONARY OEDEMA6 reports
PYREXIA6 reports
ROSACEA6 reports
SINUS ARRHYTHMIA6 reports
SWELLING6 reports
URTICARIA6 reports
ASTHENIA5 reports
CATARACT NUCLEAR5 reports
CHRONIC KIDNEY DISEASE5 reports
DIPLOPIA5 reports
DISCOMFORT5 reports
EMOTIONAL DISTRESS5 reports
EYE SWELLING5 reports
FALL5 reports
FLUSHING5 reports
HYPERHIDROSIS5 reports
HYPERTENSION5 reports
LOSS OF CONSCIOUSNESS5 reports
NEUROTOXICITY5 reports
PHOTOPSIA5 reports
POST PROCEDURAL COMPLICATION5 reports
RETINAL TOXICITY5 reports
SUBRETINAL FLUID5 reports
SWELLING FACE5 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS5 reports
BACTERIAL TEST POSITIVE4 reports
BLOOD GLUCOSE INCREASED4 reports
BLOOD PRESSURE INCREASED4 reports
CARDIAC ARREST4 reports
CIRCUMORAL SWELLING4 reports
CONJUNCTIVITIS4 reports
DERMATITIS4 reports
DRUG INTERACTION4 reports
DYSPHAGIA4 reports
DYSURIA4 reports
ENDOCRINE OPHTHALMOPATHY4 reports
EYE DISCHARGE4 reports
EYE HAEMORRHAGE4 reports
EYE PRURITUS4 reports
FEELING ABNORMAL4 reports
HYPERTRANSAMINASAEMIA4 reports
INTRAOCULAR PRESSURE INCREASED4 reports
IRIDOCYCLITIS4 reports

Report Outcomes

Out of 376 classified reports for TETRACAINE:

Serious 78.7%Non-Serious 21.3%

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

Female184 (56.8%)
Male137 (42.3%)
Unknown3 (0.9%)

Reports by Age

Age 6511 reports
Age 7710 reports
Age 429 reports
Age 168 reports
Age 618 reports
Age 758 reports
Age 637 reports
Age 647 reports
Age 667 reports
Age 707 reports
Age 626 reports
Age 816 reports
Age 846 reports
Age 25 reports
Age 455 reports
Age 485 reports
Age 525 reports
Age 605 reports
Age 685 reports
Age 735 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 TETRACAINE?

This profile reflects 876 FDA FAERS reports that mention TETRACAINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TETRACAINE?

Frequently reported terms in FAERS include OFF LABEL USE, ENDOPHTHALMITIS, INFLAMMATION, VISION BLURRED, CORNEAL EPITHELIUM DEFECT, TOXIC ANTERIOR SEGMENT SYNDROME. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TETRACAINE?

Labeling and FAERS entries often list Bellus Medical, LLC in connection with TETRACAINE. 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.