Drug · FAERS side-effect profile with label screen
Ropivacaine side effects: what 2,349 FDA adverse event reports show
Drug class
Amide local anesthetic
FDA label, Indications wording of the closest related product
Label matched
Ropivacaine Hydrochloride (Ropivacaine Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,349 reports · 90% serious · 118 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : Epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management : Epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.
FDA label, Indications and Usage
What it is
Ropivacaine Hydrochloride Injection, USP contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for 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 12Labeled (related wording) 5Reporting / coding artifact 2Lab 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.
- 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. 48 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 |
|---|---|---|---|---|---|---|
| Oedema | 553 | 92.1 85.6–99.1ROR 120.1 · χ² 49,349 / p <1e-300 | 90.9 EB05 84.7 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 73.2 · ♀ 100% (drug 73%) | no trial data cached |
| Wheezing | 526 | 80.0 74.2–86.3ROR 102.8 · χ² 40,724 / p <1e-300 | 79.1 EB05 73.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 69.9 · ♀ 99% (drug 73%) | no trial data cached |
| Respiratory tract infection | 202 | 70.0 61.3–79.9ROR 76.4 · χ² 13,570 / p <1e-300 | 69.0 EB05 61.4 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 54.4 · ♀ 100% (drug 73%) | no trial data cached |
| Asthma | 535 | 42.8 39.7–46.1ROR 55.1 · χ² 21,803 / p <1e-300 | 42.5 EB05 39.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 38.4 · ♀ 100% (drug 73%) | no trial data cached |
| Anaphylactic shock | 88 | 30.7 25.0–37.7ROR 31.9 · χ² 2,497 / p <1e-300 | 30.5 EB05 25.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · 92% clinician | no trial data cached |
| Grand mal convulsion | 28 | 26.7 18.5–38.7ROR 27.1 · χ² 667 / p 2e-147 | 26.3 EB05 19.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · 100% clinician | no trial data cached |
| Drug hypersensitivity | 562 | 25.9 24.1–27.8ROR 33.7 · χ² 13,511 / p <1e-300 | 25.8 EB05 24.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 45.9 · ♀ 98% (drug 73%) | no trial data cached |
| Respiratory depression | 26 | 19.0 12.9–27.8ROR 19.2 · χ² 424 / p 2e-94 | 18.6 EB05 13.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 96% clinician | no trial data cached |
| Motor dysfunction | 19 | 16.8 10.7–26.3ROR 16.9 · χ² 266 / p 4e-60 | 16.3 EB05 10.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Pneumonia (lung infection) | 558 | 15.4 14.3–16.6ROR 19.9 · χ² 7,619 / p <1e-300 | 15.4 EB05 14.3 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.3 · ♀ 99% (drug 73%) | no trial data cached |
| Generalised tonic-clonic seizure | 28 | 15.3 10.6–22.1ROR 15.5 · χ² 360 / p 2e-80 | 14.9 EB05 10.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 96% (drug 73%) · 93% clinician | no trial data cached |
| Caesarean section | 19 | 14.4 9.2–22.6ROR 14.5 · χ² 224 / p 6e-51 | 13.8 EB05 8.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Drug toxicity | 20 | 12.9 8.4–20.0ROR 13.0 · χ² 208 / p 2e-47 | 12.2 EB05 7.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Neurotoxicity | 25 | 12.9 8.7–19.0ROR 13.0 · χ² 261 / p 4e-59 | 12.3 EB05 8.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 96% clinician | no trial data cached |
| Ventricular fibrillation | 15 | 12.0 7.3–19.9ROR 12.1 · χ² 141 / p 9e-33 | 10.8 EB05 6.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Vomiting | 575 | 11.0 10.2–11.8ROR 14.2 · χ² 5,304 / p <1e-300 | 10.9 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · ♀ 99% (drug 73%) | no trial data cached |
| Sopor | 16 | 10.7 6.6–17.4ROR 10.8 · χ² 131 / p 1e-30 | 9.4 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Supraventricular tachycardia | 11 | 10.3 5.7–18.5ROR 10.3 · χ² 83 / p 4e-20 | 8.4 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Hepatic cytolysis | 14 | 10.2 6.1–17.3ROR 10.3 · χ² 108 / p 2e-25 | 8.7 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Post procedural complication | 22 | 10.2 6.7–15.5ROR 10.3 · χ² 174 / p 6e-40 | 9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · ♀ 50% (drug 73%) | no trial data cached |
| Bronchospasm (airway tightening) | 16 | 10.0 6.1–16.3ROR 10.0 · χ² 120 / p 3e-28 | 8.7 EB05 5.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Circulatory collapse | 19 | 9.9 6.3–15.5ROR 10.0 · χ² 144 / p 2e-33 | 8.8 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Paralysis | 15 | 9.3 5.6–15.4ROR 9.4 · χ² 103 / p 1e-24 | 7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 574 | 9.1 8.4–9.7ROR 11.7 · χ² 4,220 / p <1e-300 | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 · ♀ 97% (drug 73%) | no trial data cached |
| Chest pain | 186 | 9.0 7.8–10.3ROR 9.6 · χ² 1,316 / p 2e-288 | 8.8 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · ♀ 96% (drug 73%) | no trial data cached |
| Salivary hypersecretion | 10 | 8.9 4.8–16.6ROR 9.0 · χ² 63 / p 1e-15 | 7.0 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Bradycardia (slow heart rate) | 51 | 8.6 6.5–11.2ROR 8.7 · χ² 334 / p 6e-75 | 8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · ♀ 42% (drug 73%) · 94% clinician | no trial data cached |
| Post procedural haemorrhage | 11 | 8.4 4.7–15.2ROR 8.4 · χ² 65 / p 5e-16 | 6.7 EB05 3.8 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Movement disorder | 30 | 8.3 5.8–11.9ROR 8.4 · χ² 186 / p 1e-42 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 100% clinician | no trial data cached |
| Lymphopenia | 13 | 8.3 4.8–14.2ROR 8.3 · χ² 76 / p 2e-18 | 6.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Convulsion (seizure) | 53 | 8.2 6.3–10.6ROR 8.3 · χ² 326 / p 3e-73 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 100% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 20 | 8.1 5.2–12.5ROR 8.1 · χ² 117 / p 2e-27 | 7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 · 80% consumer | no trial data cached |
| Cardiac arrest (heart stopping) | 71 | 7.7 6.1–9.6ROR 7.9 · χ² 405 / p 2e-90 | 7.4 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 99% clinician | no trial data cached |
| Renal failure acute | 33 | 6.8 4.9–9.6ROR 6.9 · χ² 159 / p 9e-37 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 91% clinician | no trial data cached |
| Sensory disturbance | 12 | 6.6 3.8–11.7ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Haematuria (blood in urine) | 25 | 6.5 4.4–9.6ROR 6.6 · χ² 111 / p 3e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 100% (drug 73%) | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 40 | 6.5 4.8–8.8ROR 6.6 · χ² 181 / p 1e-41 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 95% clinician | no trial data cached |
| Ventricular tachycardia | 12 | 6.5 3.7–11.4ROR 6.5 · χ² 50 / p 7e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Sinus tachycardia | 10 | 6.3 3.4–11.7ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Shock | 16 | 6.3 3.8–10.2ROR 6.3 · χ² 66 / p 3e-16 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | 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 |
|---|---|---|---|---|---|---|
| Vomiting | 575 | 11.0 10.2–11.8ROR 14.2 · χ² 5,304 / p <1e-300 | 10.9 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · ♀ 99% (drug 73%) | no trial data cached |
| Dyspnoea (shortness of breath) | 574 | 9.1 8.4–9.7ROR 11.7 · χ² 4,220 / p <1e-300 | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 · ♀ 97% (drug 73%) | no trial data cached |
| Drug hypersensitivity | 562 | 25.9 24.1–27.8ROR 33.7 · χ² 13,511 / p <1e-300 | 25.8 EB05 24.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 45.9 · ♀ 98% (drug 73%) | no trial data cached |
| Pneumonia (lung infection) | 558 | 15.4 14.3–16.6ROR 19.9 · χ² 7,619 / p <1e-300 | 15.4 EB05 14.3 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.3 · ♀ 99% (drug 73%) | no trial data cached |
| Oedema | 553 | 92.1 85.6–99.1ROR 120.1 · χ² 49,349 / p <1e-300 | 90.9 EB05 84.7 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 73.2 · ♀ 100% (drug 73%) | no trial data cached |
| Asthma | 535 | 42.8 39.7–46.1ROR 55.1 · χ² 21,803 / p <1e-300 | 42.5 EB05 39.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 38.4 · ♀ 100% (drug 73%) | no trial data cached |
| Wheezing | 526 | 80.0 74.2–86.3ROR 102.8 · χ² 40,724 / p <1e-300 | 79.1 EB05 73.6 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 69.9 · ♀ 99% (drug 73%) | no trial data cached |
| Malaise (feeling unwell) | 222 | 4.5 4.0–5.1ROR 4.9 · χ² 615 / p 4e-136 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · ♀ 97% (drug 73%) | no trial data cached |
| Respiratory tract infection | 202 | 70.0 61.3–79.9ROR 76.4 · χ² 13,570 / p <1e-300 | 69.0 EB05 61.4 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 54.4 · ♀ 100% (drug 73%) | no trial data cached |
| Chest pain | 186 | 9.0 7.8–10.3ROR 9.6 · χ² 1,316 / p 2e-288 | 8.8 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · ♀ 96% (drug 73%) | no trial data cached |
| Cough | 175 | 5.6 4.8–6.4ROR 6.0 · χ² 662 / p 2e-146 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · ♀ 99% (drug 73%) | no trial data cached |
| Hypotension (low blood pressure) | 113 | 5.0 4.2–6.0ROR 5.2 · χ² 365 / p 1e-81 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 93% clinician | no trial data cached |
| Anaphylactic shock | 88 | 30.7 25.0–37.7ROR 31.9 · χ² 2,497 / p <1e-300 | 30.5 EB05 25.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · 92% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 71 | 7.7 6.1–9.6ROR 7.9 · χ² 405 / p 2e-90 | 7.4 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 99% clinician | no trial data cached |
| Convulsion (seizure) | 53 | 8.2 6.3–10.6ROR 8.3 · χ² 326 / p 3e-73 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 100% 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.
- Wheezing — n=526, PRR 80.0
- Asthma — n=535, PRR 42.8
- Anaphylactic shock — n=88, PRR 30.7
- Grand mal convulsion — n=28, PRR 26.7
- Generalised tonic-clonic seizure — n=28, PRR 15.3
- Neurotoxicity — n=25, PRR 12.9
- Movement disorder — n=30, PRR 8.3
- Renal failure acute — n=33, PRR 6.8
- Haematuria — n=25, PRR 6.5
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 Ropivacaine?
In FDA FAERS, the most frequently co-reported reaction terms for Ropivacaine are vomiting, dyspnoea, drug hypersensitivity, pneumonia, oedema, asthma. 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 Ropivacaine have an FDA boxed warning?
No. The FDA label retrieved for Ropivacaine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ropivacaine 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 35743510-728d-407b-b501-cf019665cd35, effective 20260304; matched on
openfda.generic_name.exact:"ROPIVACAINE HYDROCHLORIDE") - 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, 88 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.