Drug · FAERS side-effect profile with label screen
Bupivacaine side effects: what 9,290 FDA adverse event reports show
Brand names
Exparel
openFDA label
Who reports
9,290 reports · 75% serious · 578 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal.
FDA label, Indications and Usage
What it is
EXPAREL (bupivacaine liposome injectable suspension) is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension consisting of multivesicular liposomes containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 6Not in label — unassessed 28
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 983 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anterior spinal artery syndrome | 24 | 890.7 555.0–1,429.3ROR 893.0 · χ² 14,605 / p <1e-300 | 421.7 EB05 298.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 65%) · 100% clinician | no trial data cached |
| Maternal exposure during delivery | 252 | 793.7 688.4–915.1ROR 815.8 · χ² 146,498 / p <1e-300 | 560.3 EB05 504.6 · IC025 +7.9 3/3 methods agree | Reporting / coding artifact | serious n=202 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Purtscher retinopathy | 13 | 466.9 256.9–848.6ROR 467.5 · χ² 4,618 / p <1e-300 | 246.5 EB05 153.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Platelet aggregation inhibition | 15 | 439.5 252.7–764.3ROR 440.2 · χ² 5,120 / p <1e-300 | 250.3 EB05 161.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Local anaesthetic systemic toxicity | 160 | 412.8 349.2–488.1ROR 420.0 · χ² 55,107 / p <1e-300 | 334.5 EB05 293.2 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=159 · 97% clinician | no trial data cached |
| Acute macular neuroretinopathy | 25 | 403.4 263.6–617.3ROR 404.5 · χ² 8,158 / p <1e-300 | 270.9 EB05 193.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 28% (drug 65%) · 100% clinician | no trial data cached |
| Inspiratory capacity decreased | 36 | 339.7 239.3–482.1ROR 341.0 · χ² 10,255 / p <1e-300 | 255.0 EB05 192.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 0% (drug 65%) · 100% clinician | no trial data cached |
| Horner's syndrome | 10 | 305.0 157.6–590.5ROR 305.3 · χ² 2,404 / p <1e-300 | 177.9 EB05 103.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Foetal exposure during delivery | 73 | 269.6 211.6–343.4ROR 271.7 · χ² 17,185 / p <1e-300 | 226.3 EB05 186.0 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=73 · 93% clinician | no trial data cached |
| Arthrofibrosis | 10 | 265.1 137.6–510.5ROR 265.4 · χ² 2,121 / p <1e-300 | 163.7 EB05 95.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Parophthalmia | 23 | 242.7 157.9–373.1ROR 243.3 · χ² 4,777 / p <1e-300 | 185.5 EB05 130.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 65%) | no trial data cached |
| Chondrolysis | 46 | 242.1 178.7–328.0ROR 243.3 · χ² 9,747 / p <1e-300 | 200.4 EB05 156.3 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=44 · ♀ 43% (drug 65%) · 96% clinician | no trial data cached |
| Vascular resistance systemic decreased | 12 | 219.0 121.1–396.1ROR 219.3 · χ² 2,177 / p <1e-300 | 151.8 EB05 92.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Implant site extravasation | 64 | 198.8 154.0–256.5ROR 200.1 · χ² 11,380 / p <1e-300 | 173.2 EB05 140.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=48 | no trial data cached |
| Phrenic nerve paralysis | 17 | 192.1 117.1–315.2ROR 192.5 · χ² 2,802 / p <1e-300 | 147.9 EB05 97.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Medical device site pain | 44 | 191.7 141.0–260.7ROR 192.6 · χ² 7,512 / p <1e-300 | 164.1 EB05 127.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Lagophthalmos | 30 | 178.1 122.9–258.2ROR 178.7 · χ² 4,730 / p <1e-300 | 149.5 EB05 109.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | no trial data cached |
| Spinal cord infarction | 31 | 171.7 119.2–247.3ROR 172.3 · χ² 4,727 / p <1e-300 | 145.4 EB05 107.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=31 · 93% clinician | no trial data cached |
| Macular ischaemia | 10 | 162.5 85.6–308.8ROR 162.7 · χ² 1,349 / p 1e-295 | 118.0 EB05 68.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pulmonary air leakage | 10 | 162.5 85.6–308.8ROR 162.7 · χ² 1,349 / p 1e-295 | 118.0 EB05 68.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Medical device site discharge | 10 | 155.7 82.0–295.5ROR 155.9 · χ² 1,296 / p 5e-284 | 114.4 EB05 66.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Overlap syndrome | 44 | 153.8 113.4–208.6ROR 154.5 · χ² 6,106 / p <1e-300 | 135.6 EB05 105.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 65%) · 100% clinician | no trial data cached |
| Anaesthetic complication | 141 | 125.7 106.2–148.8ROR 127.7 · χ² 16,399 / p <1e-300 | 117.2 EB05 101.9 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=115 · 98% clinician | no trial data cached |
| Cauda equina syndrome | 39 | 119.9 87.0–165.4ROR 120.4 · χ² 4,253 / p <1e-300 | 108.0 EB05 82.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=39 · 97% clinician | no trial data cached |
| Systemic toxicity | 10 | 117.8 62.4–222.5ROR 117.9 · χ² 992 / p 5e-218 | 92.7 EB05 53.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Rhythm idioventricular | 15 | 109.1 65.0–183.2ROR 109.3 · χ² 1,431 / p <1e-300 | 92.2 EB05 59.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Brachial plexopathy | 10 | 106.5 56.5–200.9ROR 106.7 · χ² 900 / p 6e-198 | 85.6 EB05 49.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Neuromuscular block prolonged | 16 | 101.5 61.5–167.5ROR 101.7 · χ² 1,428 / p <1e-300 | 87.3 EB05 57.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Uterine atony | 11 | 100.8 55.1–184.4ROR 100.9 · χ² 946 / p 4e-208 | 83.0 EB05 49.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Therapeutic product effect prolonged | 18 | 94.5 59.0–151.4ROR 94.7 · χ² 1,509 / p <1e-300 | 83.0 EB05 55.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Bradycardia foetal | 32 | 91.8 64.5–130.7ROR 92.1 · χ² 2,674 / p <1e-300 | 83.9 EB05 62.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=31 · 100% clinician | no trial data cached |
| Procedural hypotension | 33 | 90.4 63.9–127.9ROR 90.7 · χ² 2,718 / p <1e-300 | 82.9 EB05 61.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=23 · ♀ 90% (drug 65%) · 100% clinician | no trial data cached |
| Myopathy toxic | 22 | 86.4 56.5–132.2ROR 86.6 · χ² 1,706 / p <1e-300 | 77.8 EB05 54.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Arachnoiditis | 24 | 81.1 54.0–121.8ROR 81.3 · χ² 1,755 / p <1e-300 | 73.9 EB05 52.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Delayed recovery from anaesthesia | 31 | 76.3 53.4–109.0ROR 76.5 · χ² 2,154 / p <1e-300 | 70.7 EB05 52.2 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=31 · 96% clinician | no trial data cached |
| Spinal cord oedema | 12 | 75.7 42.6–134.5ROR 75.8 · χ² 785 / p 6e-173 | 65.9 EB05 40.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Device damage | 26 | 75.0 50.8–110.8ROR 75.2 · χ² 1,765 / p <1e-300 | 69.1 EB05 49.5 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=25 · 77% consumer | no trial data cached |
| Postoperative ileus | 18 | 74.4 46.5–118.9ROR 74.5 · χ² 1,191 / p 3e-261 | 67.1 EB05 44.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Procedural nausea | 24 | 70.6 47.0–105.9ROR 70.8 · χ² 1,529 / p <1e-300 | 65.1 EB05 46.0 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=14 | no trial data cached |
| Labelled drug-drug interaction medication error | 249 | 64.8 57.2–73.4ROR 66.5 · χ² 15,138 / p <1e-300 | 62.7 EB05 56.4 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 14.2 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 895 | 2.3 2.2–2.5ROR 2.5 · χ² 706 / p 6e-156 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Pain | 770 | 2.8 2.6–3.0ROR 3.0 · χ² 934 / p 2e-205 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Drug ineffective (drug did not work) | 717 | 1.2 1.1–1.3ROR 1.2 · χ² 32 / p 6e-9 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Hypotension (low blood pressure) | 541 | 6.1 5.6–6.6ROR 6.4 · χ² 2,324 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 91% clinician | no trial data cached |
| Nausea | 410 | 1.2 1.1–1.3ROR 1.2 · χ² 11 / p 5e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Hypoaesthesia (numbness) | 379 | 5.7 5.2–6.3ROR 5.9 · χ² 1,479 / p <1e-300 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Maternal exposure during pregnancy | 374 | 9.6 8.7–10.6ROR 10.0 · χ² 2,876 / p <1e-300 | 9.5 EB05 8.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Exposure during pregnancy | 335 | 12.2 11.0–13.6ROR 12.6 · χ² 3,432 / p <1e-300 | 12.1 EB05 11.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.7 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Drug withdrawal syndrome | 281 | 7.2 6.4–8.0ROR 7.4 · χ² 1,487 / p <1e-300 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Vomiting | 276 | 1.3 1.2–1.5ROR 1.3 · χ² 23 / p 1e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Maternal exposure during delivery | 252 | 793.7 688.4–915.1ROR 815.8 · χ² 146,498 / p <1e-300 | 560.3 EB05 504.6 · IC025 +7.9 3/3 methods agree | Reporting / coding artifact | serious n=202 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Labelled drug-drug interaction medication error | 249 | 64.8 57.2–73.4ROR 66.5 · χ² 15,138 / p <1e-300 | 62.7 EB05 56.4 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 14.2 | no trial data cached |
| Overdose | 235 | 2.5 2.2–2.8ROR 2.5 · χ² 202 / p 3e-46 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Foetal exposure during pregnancy | 226 | 6.3 5.5–7.2ROR 6.4 · χ² 1,002 / p 3e-220 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 95% clinician | no trial data cached |
| No adverse event | 218 | 2.8 2.4–3.2ROR 2.8 · χ² 248 / p 4e-56 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anterior spinal artery syndrome — n=24, PRR 890.7
- Local anaesthetic systemic toxicity — n=160, PRR 412.8
- Acute macular neuroretinopathy — n=25, PRR 403.4
- Inspiratory capacity decreased — n=36, PRR 339.7
- Parophthalmia — n=23, PRR 242.7
- Implant site extravasation — n=64, PRR 198.8
- Medical device site pain — n=44, PRR 191.7
- Lagophthalmos — n=30, PRR 178.1
- Spinal cord infarction — n=31, PRR 171.7
- Overlap syndrome — n=44, PRR 153.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Bupivacaine?
In FDA FAERS, the most frequently co-reported reaction terms for Bupivacaine are pain, hypotension, nausea, hypoaesthesia, drug withdrawal syndrome, vomiting. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Bupivacaine have an FDA boxed warning?
No. The FDA label retrieved for Bupivacaine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bupivacaine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID bb5a9e59-0f51-11df-8a39-0800200c9a66, effective 20251212; matched on
openfda.generic_name.exact:"BUPIVACAINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,023 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.