Drug · FAERS side-effect profile with label screen
Bupivacaine and Epinephrine Bitartrate side effects: what 3,097 FDA adverse event reports show
Drug class
Amide Local Anesthetic
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Bupivacaine (Exparel)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,097 reports · 54% serious · 99 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 7Labeled (related wording) 7Reporting / coding artifact 8Not in label — unassessed 18
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.
- 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. 78 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 range of motion decreased | 98 | 50.0 41.1–60.8ROR 51.6 · χ² 4,625 / p <1e-300 | 49.2 EB05 41.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 68.0 · 90% clinician | no trial data cached |
| Joint injury | 135 | 43.0 36.4–50.8ROR 44.9 · χ² 5,468 / p <1e-300 | 42.5 EB05 36.8 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 59.1 · ♀ 43% (drug 65%) | no trial data cached |
| Musculoskeletal pain | 203 | 26.1 22.9–29.8ROR 27.9 · χ² 4,872 / p <1e-300 | 26.0 EB05 23.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 44.6 · 91% clinician | no trial data cached |
| Musculoskeletal discomfort | 56 | 22.1 17.0–28.7ROR 22.5 · χ² 1,105 / p 1e-242 | 21.9 EB05 17.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 40.5 | no trial data cached |
| Rotator cuff syndrome | 23 | 12.1 8.0–18.2ROR 12.2 · χ² 223 / p 1e-50 | 11.4 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 95% clinician | no trial data cached |
| Caesarean section | 19 | 11.0 7.0–17.2ROR 11.0 · χ² 162 / p 2e-37 | 9.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Drug effect incomplete | 56 | 10.3 7.9–13.4ROR 10.5 · χ² 461 / p 1e-102 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Musculoskeletal disorder | 29 | 10.3 7.1–14.8ROR 10.4 · χ² 233 / p 5e-53 | 9.6 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.9 · ♀ 34% (drug 65%) | no trial data cached |
| Sensory disturbance | 20 | 8.4 5.4–13.0ROR 8.5 · χ² 123 / p 7e-29 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.1 | no trial data cached |
| No therapeutic response | 15 | 8.2 5.0–13.6ROR 8.3 · χ² 88 / p 3e-21 | 6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 | no trial data cached |
| Post procedural complication | 23 | 8.1 5.4–12.2ROR 8.2 · χ² 136 / p 9e-32 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Bursitis | 12 | 6.7 3.8–11.9ROR 6.8 · χ² 53 / p 2e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Osteoarthritis | 42 | 6.7 5.0–9.0ROR 6.8 · χ² 198 / p 3e-45 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Motor dysfunction | 10 | 6.7 3.6–12.4ROR 6.7 · χ² 43 / p 3e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Anaphylactic shock | 25 | 6.6 4.5–9.8ROR 6.7 · χ² 114 / p 8e-27 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Status epilepticus | 11 | 6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Staphylococcal infection | 32 | 6.5 4.6–9.2ROR 6.6 · χ² 145 / p 1e-33 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 38% (drug 65%) | no trial data cached |
| Paralysis | 13 | 6.1 3.6–10.5ROR 6.2 · χ² 51 / p 5e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Drug effect decreased | 47 | 5.8 4.4–7.7ROR 5.9 · χ² 183 / p 4e-42 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 · 91% clinician | no trial data cached |
| Disseminated intravascular coagulation | 12 | 5.8 3.3–10.1ROR 5.8 · χ² 43 / p 3e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Drug ineffective (drug did not work) | 1,097 | 5.6 5.4–5.9ROR 8.2 · χ² 4,465 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| End stage renal disease | 15 | 5.5 3.3–9.1ROR 5.5 · χ² 51 / p 4e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Neurotoxicity | 14 | 5.5 3.2–9.2ROR 5.5 · χ² 47 / p 4e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Movement disorder | 24 | 5.0 3.4–7.5ROR 5.1 · χ² 74 / p 4e-18 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Device failure | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 | no trial data cached |
| Drug toxicity | 10 | 4.9 2.6–9.1ROR 4.9 · χ² 27 / p 9e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Pharmaceutical product complaint | 19 | 4.9 3.1–7.7ROR 4.9 · χ² 55 / p 6e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Economic problem | 11 | 4.8 2.7–8.7ROR 4.8 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Cardiac arrest (heart stopping) | 59 | 4.8 3.7–6.2ROR 4.9 · χ² 176 / p 2e-40 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 11 | 4.7 2.6–8.5ROR 4.7 · χ² 29 / p 4e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Activities of daily living impaired | 14 | 4.7 2.8–8.0ROR 4.7 · χ² 37 / p 5e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Drug exposure during pregnancy | 24 | 4.7 3.2–7.0ROR 4.7 · χ² 67 / p 2e-16 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 · 95% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 37 | 4.6 3.3–6.3ROR 4.6 · χ² 100 / p 9e-24 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · 91% clinician | no trial data cached |
| Abscess | 10 | 4.2 2.3–7.9ROR 4.3 · χ² 22 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Procedural pain | 17 | 4.2 2.6–6.7ROR 4.2 · χ² 38 / p 4e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Ventricular tachycardia | 10 | 4.1 2.2–7.6ROR 4.1 · χ² 20 / p 3e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Circulatory collapse | 10 | 4.0 2.1–7.4ROR 4.0 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Bradycardia (slow heart rate) | 31 | 4.0 2.8–5.6ROR 4.0 · χ² 66 / p 3e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 97% clinician | no trial data cached |
| Unresponsive to stimuli | 15 | 3.9 2.4–6.5ROR 4.0 · χ² 30 / p 2e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Scar | 10 | 3.9 2.1–7.3ROR 4.0 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | 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) | 1,097 | 5.6 5.4–5.9ROR 8.2 · χ² 4,465 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Musculoskeletal pain | 203 | 26.1 22.9–29.8ROR 27.9 · χ² 4,872 / p <1e-300 | 26.0 EB05 23.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 44.6 · 91% clinician | no trial data cached |
| Joint injury | 135 | 43.0 36.4–50.8ROR 44.9 · χ² 5,468 / p <1e-300 | 42.5 EB05 36.8 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 59.1 · ♀ 43% (drug 65%) | no trial data cached |
| Joint range of motion decreased | 98 | 50.0 41.1–60.8ROR 51.6 · χ² 4,625 / p <1e-300 | 49.2 EB05 41.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 68.0 · 90% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 80 | 3.6 2.9–4.5ROR 3.7 · χ² 150 / p 1e-34 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Product quality issue | 69 | 3.5 2.7–4.4ROR 3.5 · χ² 119 / p 4e-28 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 | no trial data cached |
| Cardiac arrest (heart stopping) | 59 | 4.8 3.7–6.2ROR 4.9 · χ² 176 / p 2e-40 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Drug effect incomplete | 56 | 10.3 7.9–13.4ROR 10.5 · χ² 461 / p 1e-102 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Musculoskeletal discomfort | 56 | 22.1 17.0–28.7ROR 22.5 · χ² 1,105 / p 1e-242 | 21.9 EB05 17.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 40.5 | no trial data cached |
| Drug effect decreased | 47 | 5.8 4.4–7.7ROR 5.9 · χ² 183 / p 4e-42 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 · 91% clinician | no trial data cached |
| Osteoarthritis | 42 | 6.7 5.0–9.0ROR 6.8 · χ² 198 / p 3e-45 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Injury | 39 | 3.7 2.7–5.1ROR 3.8 · χ² 76 / p 2e-18 | 3.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · ♀ 87% (drug 65%) | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 37 | 4.6 3.3–6.3ROR 4.6 · χ² 100 / p 9e-24 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · 91% clinician | no trial data cached |
| Convulsion (seizure) | 32 | 3.7 2.6–5.3ROR 3.8 · χ² 62 / p 2e-15 | 3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Staphylococcal infection | 32 | 6.5 4.6–9.2ROR 6.6 · χ² 145 / p 1e-33 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 38% (drug 65%) | 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=98, PRR 50.0
- Rotator cuff syndrome — n=23, PRR 12.1
- Osteoarthritis — n=42, PRR 6.7
- Anaphylactic shock — n=25, PRR 6.6
- Staphylococcal infection — n=32, PRR 6.5
- Movement disorder — n=24, PRR 5.0
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 and Epinephrine Bitartrate?
In FDA FAERS, the most frequently co-reported reaction terms for Bupivacaine and Epinephrine Bitartrate are musculoskeletal pain, joint injury, joint range of motion decreased, hypoaesthesia, cardiac arrest, musculoskeletal discomfort. 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 and Epinephrine Bitartrate have an FDA boxed warning?
No. The FDA label retrieved for Bupivacaine and Epinephrine Bitartrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bupivacaine and Epinephrine Bitartrate 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, 118 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.