Drug · FAERS side-effect profile with label screen
Phenylephrine side effects: what 4,303 FDA adverse event reports show
Who reports
4,303 reports · 88% serious · 588 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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 1No label text to screen 34
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. 228 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 |
|---|---|---|---|---|---|---|
| Premature delivery | 100 | 30.7 25.2–37.2ROR 31.4 · χ² 2,823 / p <1e-300 | 30.3 EB05 25.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.7 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Vitreous floaters | 51 | 25.7 19.5–33.7ROR 26.0 · χ² 1,178 / p 2e-258 | 25.3 EB05 20.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 | no trial data cached |
| Cardiogenic shock | 65 | 22.3 17.5–28.4ROR 22.6 · χ² 1,296 / p 4e-284 | 22.1 EB05 17.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.5 · 97% clinician | no trial data cached |
| Premature baby | 118 | 19.1 16.0–22.9ROR 19.6 · χ² 2,003 / p <1e-300 | 19.0 EB05 16.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · 96% clinician | no trial data cached |
| Metabolic acidosis | 90 | 13.9 11.3–17.1ROR 14.2 · χ² 1,063 / p 2e-233 | 13.8 EB05 11.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · 98% clinician | no trial data cached |
| Respiratory depression | 34 | 13.5 9.7–18.9ROR 13.6 · χ² 382 / p 2e-85 | 13.2 EB05 9.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · ♀ 34% (drug 57%) · 97% clinician | no trial data cached |
| Serotonin syndrome | 53 | 13.5 10.4–17.7ROR 13.7 · χ² 602 / p 3e-133 | 13.3 EB05 10.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · 100% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 145 | 13.3 11.4–15.7ROR 13.8 · χ² 1,642 / p <1e-300 | 13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · 95% clinician | no trial data cached |
| Shock | 60 | 12.8 10.0–16.5ROR 13.0 · χ² 643 / p 4e-142 | 12.6 EB05 10.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · 96% clinician | no trial data cached |
| Cardiomyopathy | 38 | 12.5 9.1–17.2ROR 12.6 · χ² 392 / p 2e-87 | 12.2 EB05 9.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · ♀ 31% (drug 57%) · 100% clinician | no trial data cached |
| Maternal exposure during pregnancy | 216 | 12.0 10.5–13.6ROR 12.5 · χ² 2,163 / p <1e-300 | 11.9 EB05 10.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 27 | 11.8 8.1–17.3ROR 11.9 · χ² 257 / p 4e-58 | 11.2 EB05 7.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 100% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 23 | 11.8 7.8–17.8ROR 11.9 · χ² 216 / p 3e-49 | 11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · ♀ 36% (drug 57%) · 100% clinician | no trial data cached |
| Drug level increased | 40 | 11.8 8.7–16.1ROR 11.9 · χ² 384 / p 9e-86 | 11.4 EB05 8.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 95% clinician | no trial data cached |
| Circulatory collapse | 41 | 11.7 8.6–15.9ROR 11.8 · χ² 390 / p 4e-87 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 100% clinician | no trial data cached |
| Mydriasis | 30 | 11.4 8.0–16.3ROR 11.5 · χ² 275 / p 5e-62 | 10.8 EB05 7.7 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 | no trial data cached |
| Renal tubular necrosis | 23 | 11.4 7.6–17.2ROR 11.5 · χ² 208 / p 2e-47 | 10.6 EB05 7.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Status epilepticus | 26 | 11.2 7.6–16.5ROR 11.3 · χ² 232 / p 1e-52 | 10.5 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 92% (drug 57%) | no trial data cached |
| Hypothermia | 23 | 11.1 7.4–16.7ROR 11.1 · χ² 200 / p 8e-46 | 10.2 EB05 6.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 100% clinician | no trial data cached |
| Encephalopathy | 55 | 11.0 8.4–14.3ROR 11.1 · χ² 488 / p 2e-108 | 10.6 EB05 8.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 78% (drug 57%) | no trial data cached |
| Hypoxia (low oxygen) | 78 | 10.9 8.7–13.5ROR 11.0 · χ² 688 / p 5e-152 | 10.6 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · 92% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 48 | 10.6 8.0–14.0ROR 10.7 · χ² 406 / p 1e-90 | 10.2 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · ♀ 86% (drug 57%) · 96% clinician | no trial data cached |
| Helicobacter infection | 22 | 10.5 6.9–16.0ROR 10.6 · χ² 180 / p 2e-41 | 9.6 EB05 6.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Exposure during pregnancy | 132 | 10.4 8.8–12.3ROR 10.7 · χ² 1,109 / p 2e-243 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 · ♀ 100% (drug 57%) · 94% clinician | no trial data cached |
| Acute respiratory failure | 40 | 10.2 7.5–13.9ROR 10.3 · χ² 322 / p 2e-72 | 9.7 EB05 7.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · 92% clinician | no trial data cached |
| Lactic acidosis | 66 | 10.0 7.9–12.8ROR 10.2 · χ² 528 / p 4e-117 | 9.7 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · 95% clinician | no trial data cached |
| Blood calcium decreased | 23 | 10.0 6.6–15.0ROR 10.0 · χ² 176 / p 2e-40 | 9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 8.1 · ♀ 100% (drug 57%) | no trial data cached |
| Multiple organ dysfunction syndrome | 54 | 9.4 7.2–12.3ROR 9.6 · χ² 399 / p 4e-89 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · 94% clinician | no trial data cached |
| Hypotension (low blood pressure) | 379 | 9.2 8.4–10.2ROR 10.0 · χ² 2,798 / p <1e-300 | 9.2 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · 95% clinician | no trial data cached |
| Visual acuity reduced | 63 | 9.2 7.2–11.7ROR 9.3 · χ² 451 / p 2e-100 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Mitral valve incompetence | 21 | 9.1 5.9–13.9ROR 9.1 · χ² 142 / p 4e-33 | 8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Cardiac arrest (heart stopping) | 149 | 8.8 7.5–10.3ROR 9.1 · χ² 1,021 / p 2e-224 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 97% clinician | no trial data cached |
| Intentional overdose | 112 | 8.6 7.1–10.3ROR 8.8 · χ² 743 / p 7e-164 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 96% clinician | no trial data cached |
| Atelectasis | 17 | 8.6 5.3–13.8ROR 8.6 · χ² 106 / p 4e-25 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Acute respiratory distress syndrome | 31 | 8.6 6.0–12.2ROR 8.6 · χ² 199 / p 2e-45 | 7.9 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · ♀ 34% (drug 57%) · 93% clinician | no trial data cached |
| Ventricular tachycardia | 29 | 8.5 5.9–12.3ROR 8.6 · χ² 185 / p 2e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 · 100% clinician | no trial data cached |
| Foetal exposure during pregnancy | 136 | 8.2 6.9–9.6ROR 8.4 · χ² 851 / p 3e-187 | 8.0 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 97% clinician | no trial data cached |
| Folliculitis | 17 | 8.0 5.0–12.9ROR 8.1 · χ² 98 / p 3e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Hand deformity | 21 | 7.8 5.1–12.0ROR 7.9 · χ² 118 / p 7e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Bursitis | 19 | 7.7 4.9–12.0ROR 7.7 · χ² 104 / p 1e-24 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | 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) | 662 | 2.5 2.3–2.6ROR 2.7 · χ² 605 / p 6e-134 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 95% clinician | no trial data cached |
| Hypotension (low blood pressure) | 379 | 9.2 8.4–10.2ROR 10.0 · χ² 2,798 / p <1e-300 | 9.2 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 · 95% clinician | no trial data cached |
| Maternal exposure during pregnancy | 216 | 12.0 10.5–13.6ROR 12.5 · χ² 2,163 / p <1e-300 | 11.9 EB05 10.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 177 | 5.7 4.9–6.6ROR 5.9 · χ² 680 / p 3e-150 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · 94% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 149 | 8.8 7.5–10.3ROR 9.1 · χ² 1,021 / p 2e-224 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 97% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 145 | 13.3 11.4–15.7ROR 13.8 · χ² 1,642 / p <1e-300 | 13.2 EB05 11.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · 95% clinician | no trial data cached |
| Drug interaction | 143 | 4.4 3.7–5.2ROR 4.5 · χ² 374 / p 1e-83 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 96% clinician | no trial data cached |
| Foetal exposure during pregnancy | 136 | 8.2 6.9–9.6ROR 8.4 · χ² 851 / p 3e-187 | 8.0 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 97% clinician | no trial data cached |
| Toxicity to various agents | 133 | 3.9 3.3–4.6ROR 4.0 · χ² 282 / p 2e-63 | 3.8 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 · 95% clinician | no trial data cached |
| Exposure during pregnancy | 132 | 10.4 8.8–12.3ROR 10.7 · χ² 1,109 / p 2e-243 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 · ♀ 100% (drug 57%) · 94% clinician | no trial data cached |
| Premature baby | 118 | 19.1 16.0–22.9ROR 19.6 · χ² 2,003 / p <1e-300 | 19.0 EB05 16.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · 96% clinician | no trial data cached |
| Intentional overdose | 112 | 8.6 7.1–10.3ROR 8.8 · χ² 743 / p 7e-164 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 96% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 105 | 5.8 4.8–7.0ROR 5.9 · χ² 410 / p 2e-91 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · 92% clinician | no trial data cached |
| Premature delivery | 100 | 30.7 25.2–37.2ROR 31.4 · χ² 2,823 / p <1e-300 | 30.3 EB05 25.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.7 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Respiratory failure | 92 | 6.2 5.0–7.5ROR 6.3 · χ² 393 / p 1e-87 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · 95% 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 Phenylephrine?
In FDA FAERS, the most frequently co-reported reaction terms for Phenylephrine are hypotension, acute kidney injury, cardiac arrest, bradycardia, toxicity to various agents, 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 Phenylephrine have an FDA boxed warning?
No. The FDA label retrieved for Phenylephrine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Phenylephrine 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 4e75da23-35f2-431c-92cb-c2c4cb3f09f1, effective 20260526; matched on
openfda.generic_name.exact:"PHENYLEPHRINE") - 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, 268 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.