LIDOCAINE 5%

N/A

Manufactured by Little Pharma, Inc.

871 FDA adverse event reports analyzed

Last updated: 2026-04-15

About LIDOCAINE 5%

LIDOCAINE 5% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Little Pharma, Inc.. The most commonly reported adverse reactions for LIDOCAINE 5% include NAUSEA, DRUG INEFFECTIVE, PAIN, HEADACHE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE 5%.

Top Adverse Reactions

NAUSEA37 reports
DRUG INEFFECTIVE36 reports
PAIN27 reports
HEADACHE26 reports
DIZZINESS23 reports
HYPOTENSION21 reports
VOMITING19 reports
FATIGUE16 reports
OFF LABEL USE15 reports
PYREXIA15 reports
ASTHENIA13 reports
DYSPNOEA13 reports
FALL13 reports
ANAESTHETIC COMPLICATION12 reports
DRUG INTERACTION12 reports
ABDOMINAL PAIN UPPER11 reports
DIARRHOEA11 reports
MUSCLE SPASMS11 reports
CARDIAC ARREST10 reports
ERYTHEMA10 reports
PHARMACEUTICAL PRODUCT COMPLAINT10 reports
POST PROCEDURAL COMPLICATION10 reports
BACK PAIN9 reports
BLOOD PRESSURE INCREASED9 reports
COUGH9 reports
GAIT DISTURBANCE9 reports
INJECTION SITE PAIN9 reports
BRADYCARDIA8 reports
CHEST PAIN8 reports
DEATH8 reports
DRUG TOXICITY8 reports
FEELING ABNORMAL8 reports
HEART RATE INCREASED8 reports
HYPERTENSION8 reports
LETHARGY8 reports
PRODUCT QUALITY ISSUE8 reports
SINUSITIS8 reports
STAPHYLOCOCCAL INFECTION8 reports
TOXIC ANTERIOR SEGMENT SYNDROME8 reports
TREMOR8 reports
AGITATION7 reports
CHILLS7 reports
CONDITION AGGRAVATED7 reports
CONFUSIONAL STATE7 reports
CONSTIPATION7 reports
CONVULSION7 reports
DIPLOPIA7 reports
DISEASE PROGRESSION7 reports
HYPERSENSITIVITY7 reports
LOSS OF CONSCIOUSNESS7 reports
MALAISE7 reports
MEDICATION ERROR7 reports
MUSCULAR WEAKNESS7 reports
PAIN IN EXTREMITY7 reports
PARAESTHESIA7 reports
PRODUCT ADHESION ISSUE7 reports
RASH7 reports
SEIZURE7 reports
SINUS TACHYCARDIA7 reports
TOXICITY TO VARIOUS AGENTS7 reports
ARTHRITIS BACTERIAL6 reports
CARDIAC DISORDER6 reports
DRY MOUTH6 reports
HYPERHIDROSIS6 reports
HYPOAESTHESIA6 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION6 reports
OVERDOSE6 reports
OXYGEN SATURATION DECREASED6 reports
PALPITATIONS6 reports
PROCEDURAL COMPLICATION6 reports
PRODUCT USE IN UNAPPROVED INDICATION6 reports
PRURITUS6 reports
URTICARIA6 reports
WEIGHT DECREASED6 reports
ANXIETY5 reports
APPLICATION SITE ERYTHEMA5 reports
APPLICATION SITE PRURITUS5 reports
ARTHRALGIA5 reports
ATRIAL FIBRILLATION5 reports
BALANCE DISORDER5 reports
CORNEAL OEDEMA5 reports
DECREASED APPETITE5 reports
DRUG EFFECT DECREASED5 reports
HEPATIC STEATOSIS5 reports
HYPOXIA5 reports
MATERNAL EXPOSURE DURING PREGNANCY5 reports
MUSCLE SPASTICITY5 reports
NASOPHARYNGITIS5 reports
PERIPHERAL SWELLING5 reports
SEPSIS5 reports
SOMNOLENCE5 reports
TACHYCARDIA5 reports
THERAPY CESSATION5 reports
THROMBOCYTOPENIA5 reports
URINARY RETENTION5 reports
URINARY TRACT INFECTION5 reports
VENTRICULAR TACHYCARDIA5 reports
ABDOMINAL DISTENSION4 reports
ABDOMINAL PAIN4 reports
ABSCESS LIMB4 reports

Report Outcomes

Out of 486 classified reports for LIDOCAINE 5%:

Serious 70.2%Non-Serious 29.8%

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

Female244 (55.2%)
Male195 (44.1%)
Unknown3 (0.7%)

Reports by Age

Age 5713 reports
Age 5512 reports
Age 4611 reports
Age 6510 reports
Age 7310 reports
Age 599 reports
Age 609 reports
Age 619 reports
Age 669 reports
Age 679 reports
Age 789 reports
Age 829 reports
Age 528 reports
Age 628 reports
Age 648 reports
Age 587 reports
Age 637 reports
Age 757 reports
Age 767 reports
Age 817 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 LIDOCAINE 5%?

This profile reflects 871 FDA FAERS reports that mention LIDOCAINE 5%. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LIDOCAINE 5%?

Frequently reported terms in FAERS include NAUSEA, DRUG INEFFECTIVE, PAIN, HEADACHE, DIZZINESS, HYPOTENSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LIDOCAINE 5%?

Labeling and FAERS entries often list Little Pharma, Inc. in connection with LIDOCAINE 5%. 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.