Drugs › Amide local anesthetic
Generic name
Bupivacaine hcl: adverse event reports filed with FDA
1,870 reports list it as a suspect or interacting product, 2004–2021. Class: Amide local anesthetic.
- 1,870
- reports as suspect product
- 0% of all reports · about 83 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 45.3%
- marked serious by the reporter
- 65.1% across the class
- 2.4%
- record death among outcomes, as reported
- 44 reports · not verified by FDA
1,870 adverse event reports received by FDA list bupivacaine hcl, a generic name as a suspect or interacting product, from January 2004 to September 2021. A further 303 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 83 reports a year and 0% of the 20,646,523 reports in the database, and 4.5% of the reports for the amide local anesthetic class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug ineffective (52.7%), activities of daily living impaired (4.1%) and joint injury (4%). A report can list several reactions, so shares add to more than 100%; 298 different terms appear across these reports. Drug ineffective is recorded in 52.7% of these reports, a larger share than in the median amide local anesthetic drug (11%).
45.3% of the reports are marked serious by the reporter (65.1% across the class); 2.4% record death among the outcomes and 11.8% record hospitalisation, as reported. 32.8% of the reports came from consumers, and the largest patient age group is 18 to 44 (13.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
Reactions recorded in the reports
share of Bupivacaine hcl reports recording the termmedian drug in amide local anesthetic
- Drug ineffectivethe medicine did not work as expected52.7%986
- Joint injury4%74
- Hypotensionlow blood pressure3%57
- Painpain, site not specified2.7%51
- Musculoskeletal disorder2.6%48
- Cardiac arrestthe heart stopped1.7%32
- Musculoskeletal painpain in muscles or bones1.7%32
- Arthropathy1.7%31
- Hypoaesthesianumbness1.7%31
- Maternal exposure during pregnancythe mother took the medicine during pregnancy1.6%30
- Product use issuea problem in how the product was used1.6%30
- Incorrect route of drug administrationthe medicine was given by the wrong route1.3%25
- Product quality issuea problem with the product itself1.3%24
- Anaesthetic complication1.2%23
- Bradycardiaslow heart rate1.2%22
- Off label useused for a purpose or in a way not on the label1.1%21
- Toxicity to various agentspoisoning or toxic effect of one or more substances1%19
- Blood pressure decreaseda low blood pressure reading1%18
- Catheter site related reaction0.9%17
- Drug hypersensitivityan allergic-type reaction to a medicine0.9%17
- Arthralgiajoint pain0.8%15
- Convulsion0.8%15
- Unresponsive to stimuli0.8%15
- Arthritis infective0.7%14
- Chondrolysis0.7%14
- Drug effect delayed0.7%14
Top 30 of 298 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the amide local anesthetic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 41,804 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 83.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Spinal anaesthesia | 355 | 19% |
| Anaesthesia | 98 | 5.2% |
| Analgesia | 91 | 4.9% |
| Local anaesthesia | 85 | 4.5% |
| Nerve block | 55 | 2.9% |
| Caesarean section | 54 | 2.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,870 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Bupivacaine hcl reports |
|---|---|---|
| Lidocaine hcl | 141 | 7.5% |
| Fentanyl | 93 | 5% |
| Fentanyl citrate | 90 | 4.8% |
| Epinephrine | 85 | 4.5% |
| Lidocaine | 66 | 3.5% |
| Propofol | 56 | 3% |
| Morphine | 41 | 2.2% |
| Morphine sulfate | 36 | 1.9% |
| Clonidine | 30 | 1.6% |
| Dexamethasone | 27 | 1.4% |
Other products listed in reports where Bupivacaine hcl is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Bupivacaine hcl | Amide local anesthetic | All reports |
|---|---|---|---|
| Reports as suspect product | 1,870 | 41,804 | 20,646,523 |
| Share of that pool | — | 4.5% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 45.3% | 65.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 24 | 77 | 91 |
| Hospitalisation recorded, per 1,000 reports | 118 | 250 | 213 |
| Consumer-filed share | 32.8% | 27% | 45.8% |
| Top term, share of reports | Drug ineffective 52.7% | median 11% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the amide local anesthetic class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Lidocaine | generic | 13,993 | 1,469 | 80% |
| Bupivacaine | generic | 5,447 | 310 | 83.3% |
| Lidocaine patch | generic | 4,474 | 113 | 4.3% |
| Lidocaine hydrochloride | generic | 3,047 | 314 | 80.7% |
| Exparel | brand | 2,157 | 217 | 42.4% |
| Marcaine | brand | 2,089 | 50 | 44.1% |
| Xylocaine (lidocaine hcl ) | generic | 2,015 | 109 | 89.9% |
| Lidocaine hcl | generic | 1,854 | 0 | 49.5% |
| Bupivacaine hydrochloride | generic | 1,797 | 251 | 62.3% |
| Ropivacaine hydrochloride | generic | 1,388 | 300 | 94.2% |
| Lidoderm | brand | 967 | 7 | 45% |
| Naropin | brand | 706 | 13 | 79.7% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Bupivacaine hcl reports
How many adverse event reports has FDA received for Bupivacaine hcl?
1,870 reports list Bupivacaine hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 303 list it only as a concomitant medication.
What reactions are recorded in Bupivacaine hcl reports?
drug ineffective (52.7%), activities of daily living impaired (4.1%), joint injury (4%), hypotension (3%) and pain (2.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Bupivacaine hcl was responsible.
How serious are the reports?
45.3% are marked serious by the reporter. Among the outcomes recorded, 2.4% of reports include death and 11.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (32.8%), other health professional (25.3%) and pharmacist (19.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Bupivacaine hcl rising?
0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Bupivacaine hcl was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Bupivacaine hcl?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Bupivacaine hcl as a suspect or interacting product; reports listing it only as a concomitant medication (303) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.