BUPIVACAINE HYDROCHLORIDE

N/A

Manufactured by Hospira, Inc.

12,011 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BUPIVACAINE HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE2,532 reports
PAIN316 reports
HYPOTENSION266 reports
OFF LABEL USE261 reports
MUSCULOSKELETAL PAIN259 reports
ANAESTHETIC COMPLICATION255 reports
HYPOAESTHESIA241 reports
MATERNAL EXPOSURE DURING PREGNANCY224 reports
JOINT INJURY204 reports
DYSPNOEA187 reports
DIZZINESS179 reports
HEADACHE177 reports
NAUSEA172 reports
CONDITION AGGRAVATED157 reports
ARTHRALGIA155 reports
VOMITING148 reports
CHONDROLYSIS141 reports
FATIGUE138 reports
HYPERTENSION137 reports
ANXIETY134 reports
CARDIAC ARREST134 reports
JOINT RANGE OF MOTION DECREASED122 reports
DRUG EFFECT INCOMPLETE117 reports
BRADYCARDIA115 reports
LOSS OF CONSCIOUSNESS108 reports
PRURITUS107 reports
OSTEOARTHRITIS106 reports
PRODUCT QUALITY ISSUE105 reports
SWELLING97 reports
PYREXIA96 reports
DRUG HYPERSENSITIVITY92 reports
PAIN IN EXTREMITY91 reports
ASTHENIA90 reports
ACTIVITIES OF DAILY LIVING IMPAIRED88 reports
HYPERSENSITIVITY87 reports
MUSCULOSKELETAL DISCOMFORT85 reports
DRUG EFFECT DECREASED82 reports
GENERAL PHYSICAL HEALTH DETERIORATION82 reports
RASH82 reports
EXPOSURE DURING PREGNANCY80 reports
PARAESTHESIA79 reports
ANAPHYLACTIC REACTION78 reports
DECREASED APPETITE77 reports
HEPATIC ENZYME INCREASED77 reports
ABDOMINAL DISCOMFORT76 reports
FIBROMYALGIA75 reports
HELICOBACTER INFECTION75 reports
MUSCULAR WEAKNESS75 reports
MUSCULOSKELETAL DISORDER75 reports
PRODUCT USE ISSUE75 reports
BLOOD PRESSURE DECREASED74 reports
BACK PAIN73 reports
ALOPECIA71 reports
ARTHROPATHY70 reports
LOCAL ANAESTHETIC SYSTEMIC TOXICITY70 reports
DISCOMFORT69 reports
GAIT DISTURBANCE69 reports
HYPOXIA69 reports
SOMNOLENCE69 reports
FALL68 reports
URTICARIA68 reports
BLOOD CHOLESTEROL INCREASED67 reports
MOBILITY DECREASED67 reports
INJURY66 reports
TYPE 2 DIABETES MELLITUS66 reports
DIARRHOEA64 reports
OVERDOSE64 reports
TACHYCARDIA64 reports
C REACTIVE PROTEIN INCREASED62 reports
DRUG WITHDRAWAL SYNDROME61 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION61 reports
INFECTION61 reports
DRUG INTOLERANCE60 reports
INFUSION RELATED REACTION60 reports
SEIZURE59 reports
CHEST PAIN58 reports
DEATH58 reports
ABDOMINAL PAIN57 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE57 reports
TOXICITY TO VARIOUS AGENTS57 reports
BLOOD PRESSURE INCREASED56 reports
CONVULSION56 reports
ADVERSE DRUG REACTION55 reports
MALAISE55 reports
WEIGHT INCREASED55 reports
OXYGEN SATURATION DECREASED54 reports
ADVERSE EVENT53 reports
CARDIOTOXICITY53 reports
DEPRESSION53 reports
ERYTHEMA53 reports
HYPERCHOLESTEROLAEMIA53 reports
INSOMNIA53 reports
MUSCLE SPASMS53 reports
DRUG EXPOSURE DURING PREGNANCY52 reports
PNEUMONIA52 reports
TREMOR52 reports
CONFUSIONAL STATE51 reports
PRODUCT USE IN UNAPPROVED INDICATION51 reports
STAPHYLOCOCCAL INFECTION51 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION50 reports

Report Outcomes

Out of 6,975 classified reports for BUPIVACAINE HYDROCHLORIDE:

Serious 56.2%Non-Serious 43.8%

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

Female3,266 (67.4%)
Male1,555 (32.1%)
Unknown24 (0.5%)

Reports by Age

Age 43103 reports
Age 3691 reports
Age 3280 reports
Age 5377 reports
Age 3575 reports
Age 5275 reports
Age 6075 reports
Age 6870 reports
Age 6769 reports
Age 6468 reports
Age 5067 reports
Age 2864 reports
Age 5862 reports
Age 3461 reports
Age 5561 reports
Age 6261 reports
Age 6660 reports
Age 7160 reports
Age 5959 reports
Age 2958 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 HYDROCHLORIDE?

This profile reflects 12,011 FDA FAERS reports that mention BUPIVACAINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUPIVACAINE HYDROCHLORIDE?

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

Who manufactures BUPIVACAINE HYDROCHLORIDE?

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