Drug · FAERS side-effect profile with label screen
Bupivacaine In Dextrose side effects: what 7,519 FDA adverse event reports show
Drug class
Amide-local anesthetic
FDA label, Indications wording of the closest related product
Label matched
Bupivacaine Hydrochloride In Dextrose (Bupivacaine Spinal)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
7,519 reports · 83% serious · 526 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). BUPIVACAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia). ( 1 )
FDA label, Indications and Usage
What it is
BUPIVACAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for BUPIVACAINE SPINAL is by subarachnoid injection.
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 6Reporting / coding artifact 8Not in label — unassessed 26
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.
- 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. 306 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 |
|---|---|---|---|---|---|---|
| Respiratory depression | 114 | 26.2 21.8–31.4ROR 26.6 · χ² 2,710 / p <1e-300 | 25.8 EB05 22.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.2 | no trial data cached |
| Myoclonus | 102 | 24.1 19.8–29.2ROR 24.4 · χ² 2,213 / p <1e-300 | 23.8 EB05 20.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.0 · 95% clinician | no trial data cached |
| No therapeutic response | 91 | 20.7 16.8–25.4ROR 20.9 · χ² 1,671 / p <1e-300 | 20.4 EB05 17.1 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 17.3 | no trial data cached |
| Premature baby | 200 | 18.6 16.2–21.3ROR 19.1 · χ² 3,294 / p <1e-300 | 18.4 EB05 16.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 95% clinician | no trial data cached |
| Premature delivery | 104 | 18.2 15.1–22.1ROR 18.5 · χ² 1,668 / p <1e-300 | 18.1 EB05 15.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 100% (drug 64%) · 97% clinician | no trial data cached |
| Muscle spasticity | 76 | 17.2 13.7–21.5ROR 17.4 · χ² 1,136 / p 2e-249 | 17.0 EB05 14.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Device failure | 90 | 16.6 13.5–20.4ROR 16.8 · χ² 1,300 / p 5e-285 | 16.5 EB05 13.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 20.8 | no trial data cached |
| Hypothermia | 60 | 16.6 12.9–21.4ROR 16.7 · χ² 859 / p 4e-189 | 16.4 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 96% clinician | no trial data cached |
| Sedation | 140 | 15.1 12.8–17.7ROR 15.3 · χ² 1,815 / p <1e-300 | 14.9 EB05 13.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Exposure during pregnancy | 327 | 14.7 13.3–16.4ROR 15.4 · χ² 4,164 / p <1e-300 | 14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · ♀ 100% (drug 64%) · 99% clinician | no trial data cached |
| Paralysis | 71 | 13.8 11.0–17.5ROR 14.0 · χ² 830 / p 1e-182 | 13.7 EB05 11.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · 92% clinician | no trial data cached |
| Caesarean section | 54 | 12.9 9.9–16.8ROR 12.9 · χ² 576 / p 1e-127 | 12.6 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 91% (drug 64%) · 96% clinician | no trial data cached |
| Post procedural complication | 86 | 12.5 10.1–15.5ROR 12.7 · χ² 897 / p 3e-197 | 12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · 97% clinician | no trial data cached |
| Maternal exposure during pregnancy | 374 | 11.9 10.8–13.1ROR 12.4 · χ² 3,713 / p <1e-300 | 11.8 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · ♀ 100% (drug 64%) · 96% clinician | no trial data cached |
| Unresponsive to stimuli | 103 | 11.2 9.2–13.6ROR 11.4 · χ² 945 / p 9e-208 | 11.0 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Incorrect route of product administration | 67 | 11.2 8.8–14.2ROR 11.3 · χ² 608 / p 2e-134 | 10.9 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 14.9 · 100% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 64 | 10.9 8.6–14.0ROR 11.0 · χ² 567 / p 1e-125 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 95% clinician | no trial data cached |
| Mental status changes | 104 | 10.5 8.6–12.7ROR 10.6 · χ² 879 / p 2e-193 | 10.3 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Bradycardia (slow heart rate) | 193 | 10.2 8.8–11.7ROR 10.4 · χ² 1,584 / p <1e-300 | 10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 97% clinician | no trial data cached |
| Urinary retention | 111 | 9.3 7.8–11.2ROR 9.5 · χ² 816 / p 1e-179 | 9.1 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Complication associated with device | 42 | 8.9 6.6–12.0ROR 8.9 · χ² 285 / p 3e-64 | 8.4 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Drug withdrawal syndrome | 281 | 8.9 7.9–9.9ROR 9.2 · χ² 1,954 / p <1e-300 | 8.8 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Motor dysfunction | 30 | 8.3 5.8–11.9ROR 8.3 · χ² 185 / p 2e-42 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 85% (drug 64%) · 93% clinician | no trial data cached |
| Circulatory collapse | 49 | 8.0 6.1–10.6ROR 8.1 · χ² 293 / p 5e-66 | 7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 96% clinician | no trial data cached |
| Foetal exposure during pregnancy | 226 | 7.8 6.8–8.8ROR 8.0 · χ² 1,329 / p 2e-291 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 95% clinician | no trial data cached |
| Anaphylactic shock | 71 | 7.7 6.1–9.8ROR 7.8 · χ² 410 / p 2e-91 | 7.4 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 88% (drug 64%) | no trial data cached |
| Hypotonia | 27 | 7.5 5.2–11.0ROR 7.6 · χ² 146 / p 6e-34 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Grand mal convulsion | 25 | 7.5 5.0–11.0ROR 7.5 · χ² 133 / p 4e-31 | 6.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 95% clinician | no trial data cached |
| Hypotension (low blood pressure) | 499 | 7.0 6.4–7.6ROR 7.4 · χ² 2,561 / p <1e-300 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 92% clinician | no trial data cached |
| Hypoxia (low oxygen) | 86 | 6.9 5.6–8.5ROR 6.9 · χ² 424 / p 2e-94 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 95% clinician | no trial data cached |
| Ventricular fibrillation | 27 | 6.8 4.6–9.9ROR 6.8 · χ² 127 / p 1e-29 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 100% clinician | no trial data cached |
| Neuralgia | 57 | 6.6 5.1–8.5ROR 6.6 · χ² 263 / p 2e-59 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Nerve injury | 26 | 6.5 4.4–9.6ROR 6.5 · χ² 116 / p 3e-27 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Brain injury | 23 | 6.4 4.3–9.6ROR 6.4 · χ² 99 / p 1e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Sinus tachycardia | 32 | 6.3 4.5–8.9ROR 6.3 · χ² 137 / p 5e-32 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 100% clinician | no trial data cached |
| Serotonin syndrome | 43 | 6.3 4.7–8.5ROR 6.3 · χ² 185 / p 2e-42 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 100% clinician | no trial data cached |
| Device occlusion | 31 | 6.2 4.4–8.9ROR 6.2 · χ² 131 / p 1e-30 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=26 | no trial data cached |
| Neurotoxicity | 38 | 6.1 4.4–8.4ROR 6.1 · χ² 157 / p 2e-36 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 100% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 176 | 5.9 5.1–6.9ROR 6.1 · χ² 719 / p 1e-158 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 91% clinician | no trial data cached |
| Depressed level of consciousness | 81 | 5.7 4.6–7.1ROR 5.8 · χ² 312 / p 5e-70 | 5.6 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 95% 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 691 | 2.2 2.1–2.4ROR 2.3 · χ² 483 / p 3e-107 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Pain | 654 | 3.0 2.8–3.2ROR 3.2 · χ² 876 / p 1e-192 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Drug ineffective (drug did not work) | 589 | 1.2 1.2–1.3ROR 1.3 · χ² 31 / p 2e-8 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.9 · 90% clinician | no trial data cached |
| Hypotension (low blood pressure) | 499 | 7.0 6.4–7.6ROR 7.4 · χ² 2,561 / p <1e-300 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 92% clinician | no trial data cached |
| Maternal exposure during pregnancy | 374 | 11.9 10.8–13.1ROR 12.4 · χ² 3,713 / p <1e-300 | 11.8 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · ♀ 100% (drug 64%) · 96% clinician | no trial data cached |
| Exposure during pregnancy | 327 | 14.7 13.3–16.4ROR 15.4 · χ² 4,164 / p <1e-300 | 14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · ♀ 100% (drug 64%) · 99% clinician | no trial data cached |
| Drug withdrawal syndrome | 281 | 8.9 7.9–9.9ROR 9.2 · χ² 1,954 / p <1e-300 | 8.8 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Hypoaesthesia (numbness) | 258 | 4.8 4.3–5.4ROR 4.9 · χ² 779 / p 1e-171 | 4.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Foetal exposure during pregnancy | 226 | 7.8 6.8–8.8ROR 8.0 · χ² 1,329 / p 2e-291 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 95% clinician | no trial data cached |
| Overdose | 216 | 2.8 2.4–3.2ROR 2.8 · χ² 247 / p 5e-56 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Somnolence (drowsiness) | 208 | 2.9 2.5–3.3ROR 2.9 · χ² 257 / p 4e-58 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Premature baby | 200 | 18.6 16.2–21.3ROR 19.1 · χ² 3,294 / p <1e-300 | 18.4 EB05 16.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 95% clinician | no trial data cached |
| Muscular weakness | 197 | 4.8 4.2–5.6ROR 4.9 · χ² 599 / p 1e-132 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Bradycardia (slow heart rate) | 193 | 10.2 8.8–11.7ROR 10.4 · χ² 1,584 / p <1e-300 | 10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 97% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 176 | 5.9 5.1–6.9ROR 6.1 · χ² 719 / p 1e-158 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 91% clinician | 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.
- Myoclonus — n=102, PRR 24.1
- Premature baby — n=200, PRR 18.6
- Premature delivery — n=104, PRR 18.2
- Muscle spasticity — n=76, PRR 17.2
- Hypothermia — n=60, PRR 16.6
- Sedation — n=140, PRR 15.1
- Caesarean section — n=54, PRR 12.9
- Unresponsive to stimuli — n=103, PRR 11.2
- Generalised tonic-clonic seizure — n=64, PRR 10.9
- Mental status changes — n=104, PRR 10.5
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 Dextrose?
In FDA FAERS, the most frequently co-reported reaction terms for Bupivacaine In Dextrose are pain, hypotension, drug withdrawal syndrome, hypoaesthesia, somnolence, premature baby. 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 In Dextrose have an FDA boxed warning?
No. The FDA label retrieved for Bupivacaine In Dextrose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bupivacaine In Dextrose 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 7a8d2539-4422-4312-0298-207ef1a2948e, effective 20260407; matched on
openfda.generic_name.exact:"BUPIVACAINE HYDROCHLORIDE IN DEXTROSE") - 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, 346 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.