BENZOCAINE

0/100 · Low Risk

Manufactured by CVS Pharmacy

No Adverse Events Reported for Benzoic Acid

Last updated: 2026-05-12

About BENZOCAINE

BENZOCAINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. Based on analysis of FDA adverse event reports, BENZOCAINE has a safety score of 0 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENZOCAINE.

AI Safety Analysis

Benzocaine has a safety concern score of 0 out of 100, placing it in the low concern category based on analysis of FDA adverse event data. The FDA has received approximately N/A adverse event reports for this medication, which is primarily manufactured by Cvs Pharmacy.

No serious or non-serious adverse events reported for Benzoic Acid.

The data shows a balanced distribution of reports across different ages and sexes. No significant trends or patterns in adverse events were observed.

Patients taking Benzocaine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 0/100

Benzocaine received a safety concern score of 0/100 (low concern). The score accounts for N/A total adverse event reports and 0 distinct reaction types. This relatively low score suggests a favorable safety profile in reported data.

Key Safety Signals

  • No serious adverse events reported.
  • No non-serious adverse events reported.
  • No adverse events reported across different age groups.

Patient Demographics

Adverse event reports by sex: Female: 568, Male: 328, Unknown: 8. The most frequently reported age groups are age 43 (34 reports), age 54 (23 reports), age 25 (20 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Demographics Breakdown

Reports by Sex

Female568 (62.8%)
Male328 (36.3%)
Unknown8 (0.9%)

Reports by Age

Age 4334 reports
Age 5423 reports
Age 2520 reports
Age 6120 reports
Age 6518 reports
Age 5817 reports
Age 7116 reports
Age 6315 reports
Age 4214 reports
Age 6914 reports
Age 6213 reports
Age 6413 reports
Age 7813 reports
Age 4912 reports
Age 6612 reports
Age 7212 reports
Age 8312 reports
Age 4611 reports
Age 4711 reports
Age 5211 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

What You Should Know

If you are taking Benzocaine, here are important things to know. No specific precautions or warnings are necessary based on the current data. Continue to follow the prescribed usage and dosing instructions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Frequently Asked Questions

How many adverse event reports has the FDA received for Benzocaine?

The FDA has received approximately N/A adverse event reports associated with Benzocaine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

Who reports adverse events for Benzocaine (by sex)?

Adverse event reports for Benzocaine break down by patient sex as follows: Female: 568, Male: 328, Unknown: 8. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Benzocaine?

The most frequently reported age groups for Benzocaine adverse events are: age 43: 34 reports, age 54: 23 reports, age 25: 20 reports, age 61: 20 reports, age 65: 18 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Benzocaine?

The primary manufacturer associated with Benzocaine adverse event reports is Cvs Pharmacy. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

How do I report a side effect from Benzocaine?

You can report adverse events from Benzocaine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Benzocaine's safety score and what does it mean?

Benzocaine has a safety concern score of 0 out of 100 (low concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. No serious or non-serious adverse events reported for Benzoic Acid.

What are the key safety signals for Benzocaine?

Key safety signals identified in Benzocaine's adverse event data include: No serious adverse events reported.. No non-serious adverse events reported.. No adverse events reported across different age groups.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

What should patients know before taking Benzocaine?

No specific precautions or warnings are necessary based on the current data. Continue to follow the prescribed usage and dosing instructions.

Are Benzocaine side effects well-documented?

Benzocaine has N/A adverse event reports on file with the FDA. The data shows a balanced distribution of reports across different ages and sexes. The volume of reports for Benzocaine reflects both the drug's usage level and the vigilance of the reporting community.

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.