BUPIVACAINE

N/A

Manufactured by Pacira Pharmaceuticals, Inc.

15,404 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BUPIVACAINE

BUPIVACAINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pacira Pharmaceuticals, Inc.. The most commonly reported adverse reactions for BUPIVACAINE include OFF LABEL USE, PAIN, DRUG INEFFECTIVE, HYPOTENSION, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPIVACAINE.

Top Adverse Reactions

OFF LABEL USE867 reports
PAIN763 reports
DRUG INEFFECTIVE698 reports
HYPOTENSION523 reports
NAUSEA403 reports
HYPOAESTHESIA372 reports
MATERNAL EXPOSURE DURING PREGNANCY357 reports
EXPOSURE DURING PREGNANCY330 reports
DRUG WITHDRAWAL SYNDROME281 reports
VOMITING272 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR245 reports
MATERNAL EXPOSURE DURING DELIVERY234 reports
OVERDOSE233 reports
FOETAL EXPOSURE DURING PREGNANCY224 reports
NO ADVERSE EVENT216 reports
SOMNOLENCE210 reports
MUSCULAR WEAKNESS205 reports
DYSPNOEA204 reports
DIZZINESS203 reports
BRADYCARDIA201 reports
PREMATURE BABY200 reports
ASTHENIA184 reports
CARDIAC ARREST178 reports
HEADACHE178 reports
BACK PAIN172 reports
LOSS OF CONSCIOUSNESS167 reports
PARAESTHESIA165 reports
DRUG INTERACTION153 reports
CONDITION AGGRAVATED151 reports
HYPERHIDROSIS151 reports
FALL149 reports
URINARY RETENTION144 reports
TOXICITY TO VARIOUS AGENTS143 reports
ANXIETY140 reports
LOCAL ANAESTHETIC SYSTEMIC TOXICITY140 reports
HOSPITALISATION139 reports
SEDATION139 reports
ANAESTHETIC COMPLICATION138 reports
PRURITUS134 reports
MUSCLE SPASMS133 reports
FATIGUE132 reports
HYPERTENSION128 reports
MALAISE127 reports
PAIN IN EXTREMITY121 reports
CONFUSIONAL STATE119 reports
SEIZURE119 reports
TACHYCARDIA118 reports
RESPIRATORY DEPRESSION115 reports
ANAPHYLACTIC REACTION105 reports
PREMATURE DELIVERY104 reports
UNRESPONSIVE TO STIMULI104 reports
MENTAL STATUS CHANGES101 reports
POST PROCEDURAL COMPLICATION101 reports
PROCEDURAL PAIN100 reports
RESPIRATORY FAILURE100 reports
CONSTIPATION99 reports
MYOCLONUS99 reports
ABDOMINAL PAIN98 reports
ARTHRALGIA96 reports
DEATH95 reports
AGITATION92 reports
INSOMNIA92 reports
NO THERAPEUTIC RESPONSE91 reports
DEVICE FAILURE90 reports
DIARRHOEA90 reports
HYPOXIA89 reports
BLOOD PRESSURE DECREASED87 reports
IMPLANT SITE PAIN87 reports
PRODUCT USE ISSUE87 reports
TREMOR86 reports
BLOOD PRESSURE INCREASED85 reports
PYREXIA85 reports
DEPRESSED LEVEL OF CONSCIOUSNESS82 reports
ADVERSE DRUG REACTION81 reports
PNEUMONIA80 reports
HYPERAESTHESIA79 reports
PRODUCT USE IN UNAPPROVED INDICATION79 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION78 reports
LOW BIRTH WEIGHT BABY78 reports
PARALYSIS78 reports
GAIT DISTURBANCE77 reports
MUSCLE SPASTICITY76 reports
DEVICE MALFUNCTION74 reports
HORNER^S SYNDROME73 reports
FOETAL EXPOSURE DURING DELIVERY72 reports
WEIGHT DECREASED72 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION71 reports
THERAPEUTIC RESPONSE DECREASED70 reports
FEELING ABNORMAL69 reports
HYPERSENSITIVITY69 reports
WITHDRAWAL SYNDROME69 reports
HEART RATE INCREASED68 reports
EXTRA DOSE ADMINISTERED67 reports
INCORRECT DOSE ADMINISTERED67 reports
INFECTION66 reports
OXYGEN SATURATION DECREASED66 reports
SENSORY LOSS66 reports
THERAPY NON RESPONDER66 reports
CHEST PAIN65 reports
DEPRESSION65 reports

Report Outcomes

Out of 9,090 classified reports for BUPIVACAINE:

Serious 74.4%Non-Serious 25.6%

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

Female4,478 (63.6%)
Male2,478 (35.2%)
Unknown85 (1.2%)

Reports by Age

Age 66145 reports
Age 67136 reports
Age 32130 reports
Age 55129 reports
Age 62129 reports
Age 74124 reports
Age 43121 reports
Age 53116 reports
Age 59112 reports
Age 63107 reports
Age 56103 reports
Age 52100 reports
Age 3699 reports
Age 4997 reports
Age 5097 reports
Age 6097 reports
Age 6497 reports
Age 3094 reports
Age 5894 reports
Age 6594 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 BUPIVACAINE?

This profile reflects 15,404 FDA FAERS reports that mention BUPIVACAINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUPIVACAINE?

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

Who manufactures BUPIVACAINE?

Labeling and FAERS entries often list Pacira Pharmaceuticals, Inc. in connection with BUPIVACAINE. 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.