Drug · FAERS side-effect profile with label screen
Adrenalinum side effects: what 41,221 FDA adverse event reports show
Drug class
alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Catecholamine
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Epinephrine
openFDA label
Who reports
41,221 reports · 63% serious · 3,503 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• For the temporary relief of symptoms including: • exhaustion • congestion • stress These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
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 4Lab value / disease marker 4No label text to screen 32
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. 1,197 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 |
|---|---|---|---|---|---|---|
| Vascular access site complication | 95 | 323.5 250.0–418.7ROR 324.2 · χ² 18,358 / p <1e-300 | 189.4 EB05 159.6 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial arm names this drug |
| Allergy to immunoglobulin therapy | 32 | 228.8 150.6–347.6ROR 229.0 · χ² 4,826 / p <1e-300 | 144.0 EB05 106.8 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=27 · ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Acquired factor v deficiency | 27 | 162.8 105.5–251.4ROR 162.9 · χ² 3,156 / p <1e-300 | 113.4 EB05 81.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · ♀ 0% (drug 64%) | no trial arm names this drug |
| Coagulation factor deficiency | 39 | 161.3 112.5–231.4ROR 161.5 · χ² 4,579 / p <1e-300 | 115.5 EB05 88.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 0% (drug 64%) | no trial arm names this drug |
| Coagulation factor v level abnormal | 27 | 140.8 91.9–215.7ROR 140.9 · χ² 2,817 / p <1e-300 | 102.3 EB05 73.8 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=27 · ♀ 0% (drug 64%) | no trial arm names this drug |
| Infusion site discharge | 330 | 121.6 107.9–137.1ROR 122.6 · χ² 31,671 / p <1e-300 | 97.5 EB05 89.0 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=296 · 84% consumer | no trial arm names this drug |
| Cardiac output increased | 30 | 108.0 72.8–160.3ROR 108.1 · χ² 2,529 / p <1e-300 | 84.4 EB05 62.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 100% (drug 64%) · 100% clinician | no trial arm names this drug |
| Blood lactic acid decreased | 30 | 106.5 71.8–157.9ROR 106.6 · χ² 2,499 / p <1e-300 | 83.5 EB05 61.3 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 100% (drug 64%) · 100% clinician | no trial arm names this drug |
| Local anaesthetic systemic toxicity | 142 | 80.7 67.6–96.3ROR 81.0 · χ² 9,556 / p <1e-300 | 69.0 EB05 60.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=142 · 100% clinician | no trial arm names this drug |
| Vitamin b1 decreased | 34 | 79.9 55.6–114.7ROR 80.0 · χ² 2,217 / p <1e-300 | 66.6 EB05 49.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=34 · ♀ 100% (drug 64%) · 100% clinician | no trial arm names this drug |
| Lagophthalmos | 55 | 78.7 59.2–104.5ROR 78.8 · χ² 3,578 / p <1e-300 | 66.6 EB05 53.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=54 · 100% clinician | no trial arm names this drug |
| Infusion site mass | 143 | 78.6 65.9–93.7ROR 78.8 · χ² 9,400 / p <1e-300 | 67.5 EB05 58.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 · 70% consumer | no trial arm names this drug |
| Infusion site bruising | 284 | 78.3 69.1–88.7ROR 78.9 · χ² 18,682 / p <1e-300 | 67.6 EB05 61.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=226 · ♀ 85% (drug 64%) · 71% consumer | no trial arm names this drug |
| Infusion site pruritus | 376 | 69.7 62.6–77.6ROR 70.3 · χ² 22,287 / p <1e-300 | 61.1 EB05 56.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=290 · ♀ 85% (drug 64%) · 72% consumer | no trial arm names this drug |
| Infusion site urticaria | 74 | 64.3 50.5–81.9ROR 64.4 · χ² 4,031 / p <1e-300 | 56.3 EB05 46.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=54 · ♀ 100% (drug 64%) | no trial arm names this drug |
| Infusion site haemorrhage | 353 | 62.1 55.6–69.3ROR 62.6 · χ² 18,824 / p <1e-300 | 55.2 EB05 50.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=283 · 71% consumer | no trial arm names this drug |
| Infusion site scar | 47 | 61.0 45.0–82.5ROR 61.0 · χ² 2,417 / p <1e-300 | 53.3 EB05 41.7 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Hereditary angioedema | 1,050 | 56.4 53.0–60.1ROR 57.9 · χ² 51,356 / p <1e-300 | 50.8 EB05 48.2 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.0 · ♀ 86% (drug 64%) | no trial arm names this drug |
| Steroid dependence | 78 | 51.3 40.7–64.8ROR 51.4 · χ² 3,444 / p <1e-300 | 46.1 EB05 38.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=78 · ♀ 33% (drug 64%) · 100% clinician | no trial arm names this drug |
| Left ventricle outflow tract obstruction | 31 | 49.4 34.2–71.5ROR 49.5 · χ² 1,295 / p 8e-284 | 43.9 EB05 32.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=31 · 100% clinician | no trial arm names this drug |
| Factor v leiden mutation | 35 | 48.9 34.6–69.2ROR 49.0 · χ² 1,454 / p <1e-300 | 43.7 EB05 32.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 0% (drug 64%) · 100% consumer | no trial arm names this drug |
| Infusion site swelling | 541 | 48.9 44.8–53.4ROR 49.6 · χ² 23,096 / p <1e-300 | 44.6 EB05 41.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=392 | no trial arm names this drug |
| Catarrh | 78 | 48.8 38.7–61.6ROR 48.9 · χ² 3,285 / p <1e-300 | 44.1 EB05 36.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=78 · ♀ 34% (drug 64%) · 100% clinician | no trial arm names this drug |
| Infusion site rash | 119 | 48.6 40.3–58.6ROR 48.7 · χ² 5,013 / p <1e-300 | 44.1 EB05 37.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 | no trial arm names this drug |
| Infusion site discomfort | 88 | 47.8 38.4–59.5ROR 47.9 · χ² 3,640 / p <1e-300 | 43.4 EB05 36.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=66 | no trial arm names this drug |
| Toxic anterior segment syndrome | 88 | 44.6 35.9–55.5ROR 44.7 · χ² 3,406 / p <1e-300 | 40.7 EB05 34.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 · 100% clinician | no trial arm names this drug |
| Multiple allergies | 604 | 42.3 39.0–46.0ROR 43.0 · χ² 22,452 / p <1e-300 | 39.1 EB05 36.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=560 · 77% consumer | no trial arm names this drug |
| Allergy to plants | 34 | 40.9 28.8–58.0ROR 40.9 · χ² 1,187 / p 2e-260 | 37.2 EB05 27.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 100% (drug 64%) · 100% consumer | no trial arm names this drug |
| Maternal exposure during delivery | 69 | 38.8 30.4–49.6ROR 38.9 · χ² 2,324 / p <1e-300 | 35.8 EB05 29.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=63 · ♀ 100% (drug 64%) · 100% clinician | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 64 | 38.1 29.6–49.1ROR 38.2 · χ² 2,114 / p <1e-300 | 35.1 EB05 28.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 0% (drug 64%) | no trial arm names this drug |
| Infusion site extravasation | 404 | 35.3 31.9–39.0ROR 35.6 · χ² 12,536 / p <1e-300 | 33.0 EB05 30.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=248 | no trial arm names this drug |
| Incorrect drug administration rate | 265 | 33.9 30.0–38.4ROR 34.2 · χ² 7,906 / p <1e-300 | 31.8 EB05 28.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=213 | no trial arm names this drug |
| Insurance issue | 926 | 33.7 31.6–36.0ROR 34.5 · χ² 27,557 / p <1e-300 | 31.7 EB05 30.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.3 · 74% consumer | no trial arm names this drug |
| Immunisation reaction | 44 | 33.3 24.5–45.1ROR 33.3 · χ² 1,261 / p 1e-276 | 30.9 EB05 24.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 64%) | no trial arm names this drug |
| Infusion site erythema | 507 | 33.1 30.2–36.2ROR 33.5 · χ² 14,765 / p <1e-300 | 31.0 EB05 28.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=367 | no trial arm names this drug |
| Stress cardiomyopathy | 350 | 32.7 29.3–36.4ROR 33.0 · χ² 10,065 / p <1e-300 | 30.7 EB05 28.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=348 · 100% clinician | no trial arm names this drug |
| Vasoplegia syndrome | 97 | 32.4 26.4–39.8ROR 32.5 · χ² 2,746 / p <1e-300 | 30.4 EB05 25.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=97 · 100% clinician | no trial arm names this drug |
| Infusion site pain | 764 | 32.3 30.0–34.7ROR 32.9 · χ² 21,755 / p <1e-300 | 30.4 EB05 28.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=566 | no trial arm names this drug |
| Liquid product physical issue | 419 | 32.0 29.0–35.3ROR 32.3 · χ² 11,805 / p <1e-300 | 30.1 EB05 27.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · 71% consumer | no trial arm names this drug |
| Myopathy toxic | 35 | 31.6 22.5–44.5ROR 31.7 · χ² 948 / p 2e-208 | 29.4 EB05 22.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Adrenalinum (searched ADRENALINUM).
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) | 4,430 | 1.7 1.7–1.8ROR 1.8 · χ² 1,396 / p <1e-300 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.8 | no trial arm names this drug |
| Headache | 3,016 | 2.5 2.4–2.5ROR 2.6 · χ² 2,668 / p <1e-300 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial arm names this drug |
| Sinusitis | 2,894 | 14.7 14.2–15.2ROR 15.7 · χ² 36,066 / p <1e-300 | 14.3 EB05 13.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.7 | no trial arm names this drug |
| Product dose omission issue | 2,756 | 5.0 4.8–5.1ROR 5.2 · χ² 8,739 / p <1e-300 | 4.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.7 | no trial arm names this drug |
| Fatigue (tiredness) | 2,736 | 1.8 1.7–1.9ROR 1.8 · χ² 992 / p 5e-218 | 1.8 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Pain | 2,446 | 2.0 1.9–2.1ROR 2.1 · χ² 1,301 / p 4e-285 | 2.0 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial arm names this drug |
| Covid-19 | 2,416 | 7.0 6.8–7.3ROR 7.4 · χ² 12,408 / p <1e-300 | 6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 2,212 | 2.0 1.9–2.1ROR 2.0 · χ² 1,117 / p 3e-245 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Nausea | 2,179 | 1.4 1.3–1.5ROR 1.4 · χ² 263 / p 2e-59 | 1.4 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Pneumonia (lung infection) | 2,056 | 3.2 3.1–3.4ROR 3.4 · χ² 3,225 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,010 | 1.2 1.1–1.2ROR 1.2 · χ² 56 / p 4e-14 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.5 | no trial arm names this drug |
| Inappropriate schedule of product administration | 1,766 | 5.1 4.9–5.4ROR 5.3 · χ² 5,839 / p <1e-300 | 5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial arm names this drug |
| Nasopharyngitis (common cold) | 1,664 | 4.6 4.4–4.8ROR 4.8 · χ² 4,701 / p <1e-300 | 4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial arm names this drug |
| Pyrexia (fever) | 1,631 | 2.4 2.3–2.5ROR 2.5 · χ² 1,348 / p 2e-295 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Urinary tract infection (bladder infection) | 1,581 | 4.8 4.5–5.0ROR 4.9 · χ² 4,686 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · ♀ 89% (drug 64%) | no trial arm names this drug |
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 Adrenalinum?
In FDA FAERS, the most frequently co-reported reaction terms for Adrenalinum are headache, sinusitis, fatigue, pain, covid-19, dyspnoea. 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 Adrenalinum have an FDA boxed warning?
No. The FDA label retrieved for Adrenalinum has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Adrenalinum 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 89fefa8e-dbad-4150-858e-c14d1f31abbf, effective 20241022; matched on
openfda.generic_name.exact:"ADRENALINUM") - 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, 1,237 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 - ClinicalTrials.gov API v2 (query
ADRENALINUM, results-bearing studies sorted by enrollment)
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.