Drug · FAERS side-effect profile with label screen
Norepinephrine (Bitartrate) side effects: what 13,044 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Norepinephrine Phenolic
openFDA label
Who reports
13,044 reports · 96% serious · 4,258 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
May temporarily relieve symptoms associated with reactions to norepinephrine. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
FDA label, Indications and Usage
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
Reporting / coding artifact 1No label text to screen 39
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 395 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 |
|---|---|---|---|---|---|---|
| Cardiogenic shock | 667 | 78.8 73.1–85.0ROR 83.0 · χ² 48,775 / p <1e-300 | 75.0 EB05 70.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.9 · 96% clinician | no trial data cached |
| Appendicitis | 293 | 52.3 46.6–58.7ROR 53.5 · χ² 14,229 / p <1e-300 | 50.5 EB05 45.8 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.7 · ♀ 6% (drug 44%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 857 | 50.9 47.7–54.4ROR 54.4 · χ² 40,639 / p <1e-300 | 49.3 EB05 46.6 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.4 · 95% clinician | no trial data cached |
| Ventricular fibrillation | 323 | 48.0 43.0–53.5ROR 49.2 · χ² 14,388 / p <1e-300 | 46.5 EB05 42.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.9 · ♀ 18% (drug 44%) · 97% clinician | no trial data cached |
| Shock | 458 | 32.9 30.1–36.0ROR 34.1 · χ² 13,867 / p <1e-300 | 32.2 EB05 29.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 · 97% clinician | no trial data cached |
| Acute respiratory distress syndrome | 268 | 24.7 21.9–27.8ROR 25.2 · χ² 5,986 / p <1e-300 | 24.3 EB05 22.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 220 | 23.8 20.8–27.1ROR 24.2 · χ² 4,712 / p <1e-300 | 23.4 EB05 20.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · 91% clinician | no trial data cached |
| Metabolic acidosis | 419 | 21.6 19.6–23.7ROR 22.2 · χ² 8,093 / p <1e-300 | 21.3 EB05 19.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 · 99% clinician | no trial data cached |
| Septic shock | 570 | 21.5 19.8–23.3ROR 22.4 · χ² 10,979 / p <1e-300 | 21.2 EB05 19.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · 94% clinician | no trial data cached |
| Ventricular tachycardia | 196 | 19.2 16.7–22.1ROR 19.5 · χ² 3,331 / p <1e-300 | 19.0 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · 95% clinician | no trial data cached |
| Ascites | 337 | 18.6 16.7–20.7ROR 19.1 · χ² 5,544 / p <1e-300 | 18.4 EB05 16.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 12% (drug 44%) · 95% clinician | no trial data cached |
| Lactic acidosis | 352 | 17.8 16.1–19.8ROR 18.3 · χ² 5,517 / p <1e-300 | 17.6 EB05 16.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · 97% clinician | no trial data cached |
| Bacterial infection | 189 | 16.5 14.3–19.0ROR 16.7 · χ² 2,714 / p <1e-300 | 16.3 EB05 14.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.3 · ♀ 11% (drug 44%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 168 | 16.2 13.9–18.9ROR 16.4 · χ² 2,362 / p <1e-300 | 16.0 EB05 14.1 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 18.8 · ♀ 10% (drug 44%) · 98% clinician | no trial data cached |
| Serotonin syndrome | 183 | 15.5 13.4–17.9ROR 15.7 · χ² 2,449 / p <1e-300 | 15.3 EB05 13.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 · ♀ 70% (drug 44%) · 97% clinician | no trial data cached |
| Multi-organ failure | 161 | 14.9 12.8–17.4ROR 15.1 · χ² 2,053 / p <1e-300 | 14.7 EB05 12.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Disseminated intravascular coagulation | 129 | 14.8 12.5–17.6ROR 14.9 · χ² 1,633 / p <1e-300 | 14.6 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · 94% clinician | no trial data cached |
| Circulatory collapse | 148 | 14.0 11.9–16.5ROR 14.2 · χ² 1,763 / p <1e-300 | 13.9 EB05 12.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · 95% clinician | no trial data cached |
| Hyperlipidaemia | 103 | 13.9 11.5–16.9ROR 14.0 · χ² 1,213 / p 5e-266 | 13.7 EB05 11.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 661 | 12.9 12.0–13.9ROR 13.6 · χ² 7,227 / p <1e-300 | 12.8 EB05 12.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 96% clinician | no trial data cached |
| Respiratory depression | 97 | 12.8 10.5–15.6ROR 12.9 · χ² 1,036 / p 1e-227 | 12.6 EB05 10.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · 99% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 374 | 11.4 10.3–12.6ROR 11.7 · χ² 3,517 / p <1e-300 | 11.3 EB05 10.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · 96% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 179 | 11.3 9.8–13.1ROR 11.5 · χ² 1,666 / p <1e-300 | 11.2 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · 100% clinician | no trial data cached |
| Coagulopathy | 116 | 11.3 9.4–13.5ROR 11.4 · χ² 1,071 / p 3e-235 | 11.1 EB05 9.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · 95% clinician | no trial data cached |
| End stage renal disease | 128 | 11.2 9.5–13.4ROR 11.3 · χ² 1,177 / p 3e-258 | 11.1 EB05 9.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · ♀ 22% (drug 44%) · 96% clinician | no trial data cached |
| Supraventricular tachycardia | 66 | 11.2 8.8–14.2ROR 11.2 · χ² 597 / p 4e-132 | 10.8 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · ♀ 65% (drug 44%) · 97% clinician | no trial data cached |
| Renal tubular necrosis | 67 | 11.0 8.7–14.0ROR 11.1 · χ² 597 / p 5e-132 | 10.7 EB05 8.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Cardiomyopathy | 100 | 10.9 9.0–13.3ROR 11.0 · χ² 887 / p 4e-195 | 10.7 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · 97% clinician | no trial data cached |
| Respiratory failure | 490 | 10.9 10.0–11.8ROR 11.2 · χ² 4,362 / p <1e-300 | 10.8 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 375 | 10.8 9.8–11.9ROR 11.1 · χ² 3,308 / p <1e-300 | 10.7 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 16% (drug 44%) · 96% clinician | no trial data cached |
| Aspiration | 72 | 10.7 8.5–13.5ROR 10.8 · χ² 623 / p 9e-138 | 10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 9% (drug 44%) · 100% clinician | no trial data cached |
| Hypotension (low blood pressure) | 1,303 | 10.5 10.0–11.1ROR 11.6 · χ² 11,250 / p <1e-300 | 10.4 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 724 | 10.5 9.8–11.3ROR 11.0 · χ² 6,199 / p <1e-300 | 10.4 EB05 9.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 94% clinician | no trial data cached |
| Neuralgia | 157 | 10.5 9.0–12.2ROR 10.6 · χ² 1,328 / p 6e-291 | 10.3 EB05 9.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 · ♀ 4% (drug 44%) · 98% clinician | no trial data cached |
| Hypoxia (low oxygen) | 226 | 10.4 9.2–11.9ROR 10.6 · χ² 1,906 / p <1e-300 | 10.3 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 96% clinician | no trial data cached |
| Hypothermia | 64 | 10.2 8.0–13.0ROR 10.2 · χ² 519 / p 4e-115 | 9.8 EB05 7.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 258 | 10.0 8.9–11.3ROR 10.2 · χ² 2,077 / p <1e-300 | 9.9 EB05 8.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · 97% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 223 | 10.0 8.8–11.4ROR 10.2 · χ² 1,793 / p <1e-300 | 9.9 EB05 8.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · 99% clinician | no trial data cached |
| Acute respiratory failure | 118 | 10.0 8.3–11.9ROR 10.0 · χ² 937 / p 4e-206 | 9.7 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 95% clinician | no trial data cached |
| Sinus bradycardia | 59 | 9.8 7.6–12.7ROR 9.9 · χ² 457 / p 8e-102 | 9.5 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · 98% 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) | 2,882 | 3.5 3.4–3.6ROR 4.2 · χ² 5,544 / p <1e-300 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 99% clinician | no trial data cached |
| Off label use (used outside approved label) | 1,348 | 2.5 2.4–2.6ROR 2.7 · χ² 1,261 / p 2e-276 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 96% clinician | no trial data cached |
| Hypotension (low blood pressure) | 1,303 | 10.5 10.0–11.1ROR 11.6 · χ² 11,250 / p <1e-300 | 10.4 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 95% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 899 | 9.5 9.0–10.2ROR 10.2 · χ² 6,872 / p <1e-300 | 9.5 EB05 9.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 857 | 50.9 47.7–54.4ROR 54.4 · χ² 40,639 / p <1e-300 | 49.3 EB05 46.6 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.4 · 95% clinician | no trial data cached |
| Condition aggravated | 819 | 4.4 4.1–4.7ROR 4.6 · χ² 2,149 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 96% clinician | no trial data cached |
| Toxicity to various agents | 726 | 7.0 6.5–7.5ROR 7.3 · χ² 3,727 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 · 98% clinician | no trial data cached |
| Sepsis (blood infection) | 724 | 10.5 9.8–11.3ROR 11.0 · χ² 6,199 / p <1e-300 | 10.4 EB05 9.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 94% clinician | no trial data cached |
| Cardiogenic shock | 667 | 78.8 73.1–85.0ROR 83.0 · χ² 48,775 / p <1e-300 | 75.0 EB05 70.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.9 · 96% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 661 | 12.9 12.0–13.9ROR 13.6 · χ² 7,227 / p <1e-300 | 12.8 EB05 12.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 96% clinician | no trial data cached |
| Septic shock | 570 | 21.5 19.8–23.3ROR 22.4 · χ² 10,979 / p <1e-300 | 21.2 EB05 19.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · 94% clinician | no trial data cached |
| Respiratory failure | 490 | 10.9 10.0–11.8ROR 11.2 · χ² 4,362 / p <1e-300 | 10.8 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 · 94% clinician | no trial data cached |
| Shock | 458 | 32.9 30.1–36.0ROR 34.1 · χ² 13,867 / p <1e-300 | 32.2 EB05 29.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 · 97% clinician | no trial data cached |
| Death | 454 | 0.8 0.8–0.9ROR 0.8 · χ² 13 / p 2e-4 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | no trial data cached |
| Vomiting | 438 | 1.5 1.4–1.6ROR 1.5 · χ² 75 / p 3e-18 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.3 · 96% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Norepinephrine (Bitartrate)?
In FDA FAERS, the most frequently co-reported reaction terms for Norepinephrine (Bitartrate) are hypotension, acute kidney injury, multiple organ dysfunction syndrome, toxicity to various agents, sepsis, cardiogenic shock. 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 Norepinephrine (Bitartrate) have an FDA boxed warning?
No. The FDA label retrieved for Norepinephrine (Bitartrate) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Norepinephrine (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 a980e5db-d7c3-4716-99cc-c392bacd0f12, effective 20230412; matched on
openfda.generic_name.exact:"NOREPINEPHRINE (BITARTRATE)") - 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, 435 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.