Drug · FAERS side-effect profile with label screen
Bupivacaine side effects: what 7,136 FDA adverse event reports show
Brand names
Exparel
openFDA label
Who reports
7,136 reports · 56% serious · 416 with death outcome · 68% 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 7Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 20
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 278 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 |
|---|---|---|---|---|---|---|
| Joint injury | 204 | 28.3 24.7–32.4ROR 29.1 · χ² 5,293 / p <1e-300 | 27.9 EB05 24.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.0 · ♀ 43% (drug 68%) | no trial data cached |
| Joint range of motion decreased | 127 | 28.2 23.7–33.5ROR 28.6 · χ² 3,269 / p <1e-300 | 27.8 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · 95% clinician | no trial data cached |
| Helicobacter infection | 84 | 24.4 19.7–30.2ROR 24.7 · χ² 1,846 / p <1e-300 | 24.1 EB05 20.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · ♀ 100% (drug 68%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 61 | 18.8 14.7–24.2ROR 19.0 · χ² 1,006 / p 4e-221 | 18.6 EB05 15.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · ♀ 100% (drug 68%) · 95% clinician | no trial data cached |
| Musculoskeletal pain | 267 | 14.9 13.3–16.8ROR 15.5 · χ² 3,442 / p <1e-300 | 14.8 EB05 13.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.3 · 92% clinician | no trial data cached |
| Musculoskeletal discomfort | 85 | 14.6 11.8–18.0ROR 14.7 · χ² 1,057 / p 5e-232 | 14.4 EB05 12.0 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.1 | no trial data cached |
| Activities of daily living impaired | 88 | 12.9 10.5–15.9ROR 13.1 · χ² 952 / p 2e-209 | 12.7 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 46% (drug 68%) | no trial data cached |
| Incorrect route of product administration | 73 | 12.8 10.2–16.1ROR 12.9 · χ² 780 / p 6e-172 | 12.6 EB05 10.3 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 25.0 · 94% clinician | no trial data cached |
| Musculoskeletal disorder | 75 | 11.5 9.2–14.5ROR 11.7 · χ² 710 / p 1e-156 | 11.3 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.1 · ♀ 42% (drug 68%) | no trial data cached |
| Folliculitis | 38 | 10.8 7.9–14.9ROR 10.9 · χ² 328 / p 1e-73 | 10.3 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 100% (drug 68%) · 100% clinician | no trial data cached |
| Fibromyalgia | 82 | 9.9 8.0–12.3ROR 10.0 · χ² 649 / p 2e-143 | 9.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 100% (drug 68%) · 96% clinician | no trial data cached |
| Respiratory depression | 41 | 9.8 7.3–13.4ROR 9.9 · χ² 316 / p 5e-71 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 95% clinician | no trial data cached |
| Neurotoxicity | 56 | 9.5 7.3–12.3ROR 9.6 · χ² 416 / p 1e-92 | 9.1 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 38% (drug 68%) · 91% clinician | no trial data cached |
| Drug effect incomplete | 117 | 9.3 7.8–11.2ROR 9.5 · χ² 863 / p 6e-190 | 9.1 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Caesarean section | 37 | 9.3 6.7–12.8ROR 9.3 · χ² 264 / p 1e-59 | 8.7 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 88% (drug 68%) · 94% clinician | no trial data cached |
| Paralysis | 45 | 9.2 6.9–12.3ROR 9.3 · χ² 321 / p 5e-72 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 | no trial data cached |
| Myoclonus | 37 | 9.1 6.6–12.6ROR 9.2 · χ² 259 / p 1e-58 | 8.5 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 94% clinician | no trial data cached |
| Foot deformity | 32 | 8.5 6.0–12.0ROR 8.5 · χ² 203 / p 2e-46 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Maternal exposure during pregnancy | 241 | 8.0 7.1–9.1ROR 8.3 · χ² 1,481 / p <1e-300 | 7.9 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Sciatica | 43 | 8.0 5.9–10.8ROR 8.0 · χ² 255 / p 1e-57 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.7 · ♀ 100% (drug 68%) · 93% clinician | no trial data cached |
| Osteoarthritis | 112 | 7.8 6.5–9.3ROR 7.9 · χ² 652 / p 3e-144 | 7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Bursitis | 30 | 7.3 5.1–10.5ROR 7.3 · χ² 157 / p 3e-36 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 96% (drug 68%) · 100% clinician | no trial data cached |
| Hand deformity | 32 | 7.2 5.1–10.2ROR 7.2 · χ² 164 / p 7e-38 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Rotator cuff syndrome | 30 | 6.8 4.8–9.8ROR 6.9 · χ² 144 / p 2e-33 | 6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 93% clinician | no trial data cached |
| No therapeutic response | 28 | 6.7 4.6–9.6ROR 6.7 · χ² 129 / p 4e-30 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Bradycardia (slow heart rate) | 120 | 6.6 5.6–7.9ROR 6.7 · χ² 570 / p 3e-126 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 94% clinician | no trial data cached |
| Premature delivery | 35 | 6.4 4.6–9.0ROR 6.5 · χ² 155 / p 7e-36 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Type 2 diabetes mellitus | 72 | 6.3 5.0–7.9ROR 6.3 · χ² 314 / p 2e-70 | 6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · ♀ 96% (drug 68%) · 93% clinician | no trial data cached |
| Post procedural complication | 41 | 6.3 4.6–8.5ROR 6.3 · χ² 176 / p 2e-40 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 90% clinician | no trial data cached |
| Motor dysfunction | 21 | 6.1 4.0–9.4ROR 6.1 · χ² 84 / p 2e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 100% clinician | no trial data cached |
| Hypoxia (low oxygen) | 72 | 6.0 4.8–7.6ROR 6.1 · χ² 298 / p 6e-67 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Autoimmune disorder | 19 | 5.8 3.7–9.1ROR 5.8 · χ² 71 / p 2e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Unresponsive to stimuli | 51 | 5.8 4.4–7.7ROR 5.9 · χ² 199 / p 2e-45 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 94% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 2,609 | 5.8 5.7–6.0ROR 8.6 · χ² 11,105 / p <1e-300 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Ventricular fibrillation | 21 | 5.5 3.6–8.5ROR 5.6 · χ² 74 / p 5e-18 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 · ♀ 33% (drug 68%) | no trial data cached |
| Hepatic cirrhosis | 35 | 5.5 4.0–7.7ROR 5.5 · χ² 124 / p 3e-29 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 94% (drug 68%) | no trial data cached |
| C-reactive protein increased | 65 | 5.3 4.1–6.7ROR 5.3 · χ² 220 / p 5e-50 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 · ♀ 98% (drug 68%) · 98% clinician | no trial data cached |
| Prescribed overdose | 34 | 5.2 3.7–7.2ROR 5.2 · χ² 110 / p 5e-26 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 93% (drug 68%) | no trial data cached |
| Anaphylactic shock | 45 | 5.2 3.9–6.9ROR 5.2 · χ² 147 / p 4e-34 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Ventricular tachycardia | 29 | 5.1 3.6–7.4ROR 5.2 · χ² 93 / p 3e-22 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 93% clinician | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 2,609 | 5.8 5.7–6.0ROR 8.6 · χ² 11,105 / p <1e-300 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Pain | 325 | 1.6 1.4–1.7ROR 1.6 · χ² 65 / p 4e-16 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Hypotension (low blood pressure) | 276 | 4.1 3.6–4.5ROR 4.2 · χ² 636 / p 1e-140 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 93% clinician | no trial data cached |
| Musculoskeletal pain | 267 | 14.9 13.3–16.8ROR 15.5 · χ² 3,442 / p <1e-300 | 14.8 EB05 13.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.3 · 92% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 255 | 5.0 4.4–5.6ROR 5.2 · χ² 817 / p 5e-180 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Maternal exposure during pregnancy | 241 | 8.0 7.1–9.1ROR 8.3 · χ² 1,481 / p <1e-300 | 7.9 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · ♀ 100% (drug 68%) · 97% clinician | no trial data cached |
| Joint injury | 204 | 28.3 24.7–32.4ROR 29.1 · χ² 5,293 / p <1e-300 | 27.9 EB05 24.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.0 · ♀ 43% (drug 68%) | no trial data cached |
| Condition aggravated | 165 | 1.6 1.4–1.9ROR 1.6 · χ² 38 / p 5e-10 | 1.6 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Arthralgia (joint pain) | 160 | 1.1 1.0–1.3ROR 1.1 · χ² 2 / p 0.059 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Hypertension (high blood pressure) | 150 | 2.1 1.8–2.4ROR 2.1 · χ² 84 / p 3e-20 | 2.1 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.6 · 92% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 140 | 5.0 4.2–5.9ROR 5.0 · χ² 441 / p 4e-98 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Anxiety | 139 | 1.4 1.2–1.7ROR 1.4 · χ² 18 / p 1e-5 | 1.4 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Joint range of motion decreased | 127 | 28.2 23.7–33.5ROR 28.6 · χ² 3,269 / p <1e-300 | 27.8 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · 95% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 120 | 6.6 5.6–7.9ROR 6.7 · χ² 570 / p 3e-126 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 94% clinician | no trial data cached |
| Drug effect incomplete | 117 | 9.3 7.8–11.2ROR 9.5 · χ² 863 / p 6e-190 | 9.1 EB05 7.8 · IC025 +2.9 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.
- Joint range of motion decreased — n=127, PRR 28.2
- Helicobacter infection — n=84, PRR 24.4
- Hypercholesterolaemia — n=61, PRR 18.8
- Activities of daily living impaired — n=88, PRR 12.9
- Folliculitis — n=38, PRR 10.8
- Fibromyalgia — n=82, PRR 9.9
- Neurotoxicity — n=56, PRR 9.5
- Caesarean section — n=37, PRR 9.3
- Myoclonus — n=37, PRR 9.1
- Foot deformity — n=32, PRR 8.5
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, musculoskeletal pain, hypoaesthesia, joint injury, arthralgia. 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, 318 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.