Drug Safety Information for BUPIVACAINE Hydrochloride (Bupivacaine hydrochloride)
Safety-related Labeling Changes for MARCAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for MARCAINE (BUPIVACAINE HYDROCHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE) Rx Drug: FDA Link
Adverse Drug Reactions for BUPIVACAINE Hydrochloride* (Bupivacaine hydrochloride)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with BUPIVACAINE Hydrochloride
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Pain | 469 |
2 | Hypotension | 351 |
3 | Drug ineffective | 331 |
4 | Musculoskeletal pain | 299 |
5 | Anaesthetic complication | 276 |
6 | Nausea | 231 |
7 | Chondrolysis | 216 |
8 | Joint injury | 213 |
9 | Hypoaesthesia | 176 |
10 | Vomiting | 166 |
11 | Drug withdrawal syndrome | 160 |
12 | Cardiac arrest | 146 |
13 | Back pain | 141 |
14 | Dyspnoea | 137 |
15 | Loss of consciousness | 136 |
16 | Convulsion | 133 |
17 | Headache | 133 |
18 | Asthenia | 129 |
19 | Post procedural complication | 125 |
20 | Dizziness | 120 |
* This side effect also appears in "Top 10 Side Effects of BUPIVACAINE Hydrochloride " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking BUPIVACAINE Hydrochloride
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Spinal anaesthesia | 1660 |
2 | Anaesthesia | 1226 |
3 | Product used for unknown indication | 949 |
4 | Musculoskeletal pain | 940 |
5 | Analgesic therapy | 919 |
6 | Pain | 789 |
7 | Local anaesthesia | 690 |
8 | Epidural anaesthesia | 521 |
9 | Nerve block | 401 |
10 | Procedural pain | 268 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for BUPIVACAINE Hydrochloride
Total Reports Filed with FDA: 22348
Number of FDA Adverse Event Reports by Patient Age for BUPIVACAINE Hydrochloride
Total Reports Filed with FDA: 22348*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bupivacaine hydrochloride (Marcaine spinal, Bupivicaine, Bupivacaine hcl, Sensorcaine mpf, Bupivacaina, Sensorcaine, Bupivacaine, Marcaine)
Charts are based on 22348 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.