Drug · FAERS side-effect profile with label screen
Norepinephrine side effects: what 10,627 FDA adverse event reports show
Who reports
10,627 reports · 97% serious · 3,390 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For temporary relief of anxiety, mood swings, dizziness, skin rashes, fears, headaches, hives and hot flashes.
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 5Lab value / disease marker 8No label text to screen 27
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.
- 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.
- 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. 980 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 |
|---|---|---|---|---|---|---|
| Appendicolith | 215 | 2,615.2 2,133.1–3,206.2ROR 2,669.2 · χ² 238,605 / p <1e-300 | 1,014.7 EB05 905.8 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=215 · ♀ 0% (drug 45%) · 97% clinician | no trial data cached |
| Sleep disorder therapy | 66 | 1,088.5 805.9–1,470.4ROR 1,095.3 · χ² 45,294 / p <1e-300 | 580.2 EB05 472.0 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=66 · ♀ 0% (drug 45%) · 98% clinician | no trial data cached |
| Antacid therapy | 41 | 1,023.0 701.3–1,492.3ROR 1,027.0 · χ² 26,772 / p <1e-300 | 510.3 EB05 392.2 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=41 · ♀ 0% (drug 45%) · 98% clinician | no trial data cached |
| Vitamin b1 increased | 13 | 903.6 468.2–1,743.9ROR 904.7 · χ² 7,399 / p <1e-300 | 323.4 EB05 201.1 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Electrocardiogram t wave alternans | 12 | 753.4 387.0–1,466.5ROR 754.2 · χ² 5,969 / p <1e-300 | 291.3 EB05 177.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Schizencephaly | 11 | 648.7 328.0–1,283.2ROR 649.4 · χ² 4,861 / p <1e-300 | 263.9 EB05 157.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Analgesic therapy | 64 | 521.2 395.8–686.3ROR 524.3 · χ² 25,799 / p <1e-300 | 366.2 EB05 296.9 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=64 · ♀ 0% (drug 45%) · 97% clinician | no trial data cached |
| Drug therapy | 60 | 456.1 344.6–603.8ROR 458.7 · χ² 21,708 / p <1e-300 | 330.7 EB05 266.2 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=60 · ♀ 0% (drug 45%) · 97% clinician | no trial data cached |
| Cerebral haemorrhage foetal | 11 | 436.9 227.2–840.0ROR 437.3 · χ² 3,559 / p <1e-300 | 220.7 EB05 131.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Blood lactic acid decreased | 30 | 414.1 279.3–613.8ROR 415.3 · χ² 9,856 / p <1e-300 | 280.5 EB05 206.0 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 100% (drug 45%) · 93% clinician | no trial data cached |
| Cardiac output increased | 28 | 386.5 257.8–579.5ROR 387.5 · χ² 8,663 / p <1e-300 | 264.4 EB05 192.0 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 100% (drug 45%) · 93% clinician | no trial data cached |
| Covid-19 treatment | 11 | 375.6 197.0–716.0ROR 376.0 · χ² 3,138 / p <1e-300 | 204.0 EB05 121.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Systolic anterior motion of mitral valve | 12 | 328.9 178.5–606.3ROR 329.3 · χ² 3,081 / p <1e-300 | 194.8 EB05 118.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Myoglobin urine present | 35 | 321.3 224.8–459.2ROR 322.4 · χ² 9,319 / p <1e-300 | 239.9 EB05 180.3 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=35 · ♀ 100% (drug 45%) · 97% clinician | no trial data cached |
| Anticoagulant therapy | 38 | 313.4 222.6–441.2ROR 314.5 · χ² 9,924 / p <1e-300 | 237.8 EB05 180.9 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=38 · ♀ 0% (drug 45%) · 97% clinician | no trial data cached |
| Vitamin b1 decreased | 32 | 289.7 199.9–419.7ROR 290.5 · χ² 7,763 / p <1e-300 | 219.3 EB05 162.7 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=32 · ♀ 100% (drug 45%) · 91% clinician | no trial data cached |
| Myocardial calcification | 13 | 248.0 139.3–441.6ROR 248.3 · χ² 2,622 / p <1e-300 | 166.7 EB05 103.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Bacteroides infection | 28 | 239.0 161.5–353.7ROR 239.6 · χ² 5,700 / p <1e-300 | 186.1 EB05 135.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 45%) · 96% clinician | no trial data cached |
| Propofol infusion syndrome | 73 | 227.7 178.8–289.9ROR 229.2 · χ² 14,547 / p <1e-300 | 193.7 EB05 159.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=71 · 100% clinician | no trial data cached |
| Malignant melanoma stage 0 | 18 | 217.6 133.7–354.0ROR 218.0 · χ² 3,298 / p <1e-300 | 162.4 EB05 108.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Burkholderia test positive | 12 | 210.4 116.0–381.6ROR 210.6 · χ² 2,072 / p <1e-300 | 146.3 EB05 89.2 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Congenital hiatus hernia | 21 | 206.4 131.7–323.5ROR 206.8 · χ² 3,698 / p <1e-300 | 159.8 EB05 110.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | no trial data cached |
| Left ventricle outflow tract obstruction | 29 | 178.6 122.2–261.1ROR 179.1 · χ² 4,530 / p <1e-300 | 147.9 EB05 108.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 70% (drug 45%) · 100% clinician | no trial data cached |
| Vasoplegia syndrome | 117 | 154.2 127.8–185.9ROR 155.9 · χ² 16,357 / p <1e-300 | 139.7 EB05 119.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=117 · 98% clinician | no trial data cached |
| Hyperdynamic left ventricle | 16 | 136.6 82.3–226.7ROR 136.8 · χ² 1,887 / p <1e-300 | 111.1 EB05 72.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Blood phosphorus increased | 142 | 108.5 91.7–128.3ROR 109.9 · χ² 14,221 / p <1e-300 | 101.4 EB05 88.2 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=142 · ♀ 7% (drug 45%) · 95% clinician | no trial data cached |
| Dry gangrene | 32 | 105.0 73.6–149.8ROR 105.3 · χ² 3,030 / p <1e-300 | 94.2 EB05 69.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · 97% clinician | no trial data cached |
| Genital erosion | 14 | 99.4 58.1–170.1ROR 99.6 · χ² 1,206 / p 2e-264 | 84.1 EB05 53.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Anion gap | 29 | 93.6 64.5–135.8ROR 93.9 · χ² 2,447 / p <1e-300 | 84.5 EB05 61.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · 100% clinician | no trial data cached |
| Pulmonary hypertensive crisis | 12 | 93.0 52.2–166.0ROR 93.1 · χ² 957 / p 2e-210 | 78.2 EB05 47.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Acid base balance abnormal | 10 | 90.9 48.3–171.4ROR 91.0 · χ² 766 / p 7e-169 | 75.0 EB05 43.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Hyperphosphataemia | 93 | 90.5 73.6–111.4ROR 91.3 · χ² 7,785 / p <1e-300 | 85.1 EB05 71.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 4% (drug 45%) · 97% clinician | no trial data cached |
| Distributive shock | 82 | 76.0 61.0–94.7ROR 76.6 · χ² 5,772 / p <1e-300 | 72.0 EB05 59.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=82 · ♀ 67% (drug 45%) · 100% clinician | no trial data cached |
| Cardiogenic shock | 525 | 75.4 69.2–82.1ROR 79.2 · χ² 37,039 / p <1e-300 | 72.4 EB05 67.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.1 · 96% clinician | no trial data cached |
| Hyperlactacidaemia | 96 | 74.5 60.8–91.3ROR 75.2 · χ² 6,634 / p <1e-300 | 70.8 EB05 59.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 · 96% clinician | no trial data cached |
| Respiratory gas exchange disorder | 13 | 71.7 41.2–124.6ROR 71.8 · χ² 807 / p 9e-178 | 63.1 EB05 39.2 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Antibiotic level above therapeutic | 13 | 66.2 38.1–115.1ROR 66.3 · χ² 746 / p 2e-164 | 58.8 EB05 36.6 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Systolic dysfunction | 32 | 61.8 43.5–87.8ROR 62.0 · χ² 1,796 / p <1e-300 | 57.9 EB05 43.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 78% (drug 45%) · 100% clinician | no trial data cached |
| Human herpesvirus 6 infection reactivation | 10 | 58.4 31.2–109.6ROR 58.5 · χ² 494 / p 1e-109 | 51.5 EB05 29.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Pharyngeal haemorrhage | 35 | 57.4 41.0–80.3ROR 57.6 · χ² 1,829 / p <1e-300 | 54.2 EB05 40.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · 91% 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) | 2,486 | 3.7 3.6–3.9ROR 4.6 · χ² 5,289 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 99% clinician | no trial data cached |
| Off label use (used outside approved label) | 1,155 | 2.6 2.5–2.8ROR 2.8 · χ² 1,212 / p 7e-266 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 97% clinician | no trial data cached |
| Hypotension (low blood pressure) | 1,045 | 10.3 9.8–11.0ROR 11.4 · χ² 8,850 / p <1e-300 | 10.3 EB05 9.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · 95% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 798 | 10.4 9.7–11.1ROR 11.2 · χ² 6,775 / p <1e-300 | 10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 680 | 49.3 45.8–53.0ROR 52.6 · χ² 31,359 / p <1e-300 | 48.0 EB05 45.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · 95% clinician | no trial data cached |
| Toxicity to various agents | 656 | 7.7 7.2–8.3ROR 8.2 · χ² 3,859 / p <1e-300 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · 98% clinician | no trial data cached |
| Condition aggravated | 589 | 3.9 3.6–4.2ROR 4.0 · χ² 1,258 / p 8e-276 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 97% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 561 | 13.4 12.4–14.6ROR 14.1 · χ² 6,431 / p <1e-300 | 13.3 EB05 12.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 552 | 9.8 9.0–10.6ROR 10.3 · χ² 4,357 / p <1e-300 | 9.7 EB05 9.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 · 94% clinician | no trial data cached |
| Cardiogenic shock | 525 | 75.4 69.2–82.1ROR 79.2 · χ² 37,039 / p <1e-300 | 72.4 EB05 67.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.1 · 96% clinician | no trial data cached |
| Septic shock | 454 | 20.9 19.1–22.9ROR 21.8 · χ² 8,526 / p <1e-300 | 20.7 EB05 19.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · 94% clinician | no trial data cached |
| Shock | 395 | 34.7 31.5–38.3ROR 36.0 · χ² 12,700 / p <1e-300 | 34.1 EB05 31.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.4 · 97% clinician | no trial data cached |
| Respiratory failure | 386 | 10.5 9.5–11.6ROR 10.8 · χ² 3,297 / p <1e-300 | 10.4 EB05 9.5 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · 93% clinician | no trial data cached |
| Metabolic acidosis | 364 | 22.9 20.7–25.4ROR 23.7 · χ² 7,540 / p <1e-300 | 22.7 EB05 20.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.5 · 98% clinician | no trial data cached |
| Intentional overdose | 352 | 11.0 9.9–12.1ROR 11.3 · χ² 3,165 / p <1e-300 | 10.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · ♀ 75% (drug 45%) · 97% 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?
In FDA FAERS, the most frequently co-reported reaction terms for Norepinephrine are hypotension, acute kidney injury, multiple organ dysfunction syndrome, toxicity to various agents, cardiac arrest, sepsis. 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 have an FDA boxed warning?
No. The FDA label retrieved for Norepinephrine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Norepinephrine 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 edf75607-d285-45e5-912e-280d13acbc2b, effective 20250404; matched on
openfda.generic_name.exact:"NOREPINEPHRINE") - 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, 1,020 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.