Drug · FAERS side-effect profile with label screen
Phenylephrine HCL side effects: what 853 FDA adverse event reports show
Who reports
853 reports · 83% serious · 201 with death outcome · 53% 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 3No label text to screen 37
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. 18 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 |
|---|---|---|---|---|---|---|
| Fear | 174 | 159.0 139.2–181.7ROR 199.6 · χ² 27,024 / p <1e-300 | 155.3 EB05 136.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 148.1 | no trial data cached |
| Multi-organ failure | 112 | 158.1 133.0–188.0ROR 181.9 · χ² 17,231 / p <1e-300 | 153.0 EB05 130.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 108.5 | no trial data cached |
| Renal injury | 152 | 125.2 108.4–144.7ROR 152.2 · χ² 18,542 / p <1e-300 | 122.7 EB05 107.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.1 | no trial data cached |
| Anhedonia | 121 | 112.9 95.7–133.3ROR 131.5 · χ² 13,268 / p <1e-300 | 110.5 EB05 94.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 85.8 | no trial data cached |
| Injury | 226 | 79.0 70.6–88.3ROR 107.1 · χ² 17,321 / p <1e-300 | 78.2 EB05 70.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.4 | no trial data cached |
| Unevaluable event | 190 | 62.0 54.6–70.2ROR 79.4 · χ² 11,345 / p <1e-300 | 61.4 EB05 54.4 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 74.6 | no trial data cached |
| Folliculitis | 24 | 57.3 38.6–85.1ROR 58.9 · χ² 1,270 / p 2e-278 | 54.8 EB05 38.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.4 · 100% clinician | no trial data cached |
| Helicobacter infection | 20 | 48.4 31.4–74.6ROR 49.5 · χ² 880 / p 1e-193 | 46.3 EB05 31.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · 100% clinician | no trial data cached |
| Stress | 128 | 43.9 37.4–51.5ROR 51.5 · χ² 5,329 / p <1e-300 | 43.5 EB05 37.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.1 | no trial data cached |
| Hypercholesterolaemia | 17 | 43.8 27.3–70.2ROR 44.7 · χ² 668 / p 1e-147 | 41.8 EB05 27.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 | no trial data cached |
| Wound infection | 18 | 40.8 25.8–64.5ROR 41.7 · χ² 659 / p 1e-145 | 39.2 EB05 26.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.2 | no trial data cached |
| Renal failure (kidney failure) | 219 | 40.4 36.0–45.2ROR 54.0 · χ² 8,406 / p <1e-300 | 40.2 EB05 35.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.0 | no trial data cached |
| Renal impairment | 125 | 36.8 31.3–43.3ROR 43.0 · χ² 4,331 / p <1e-300 | 36.6 EB05 31.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 | no trial data cached |
| Pemphigus | 18 | 35.7 22.6–56.4ROR 36.4 · χ² 572 / p 1e-126 | 34.5 EB05 23.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.7 | no trial data cached |
| Hand deformity | 18 | 33.9 21.5–53.6ROR 34.6 · χ² 542 / p 4e-120 | 32.8 EB05 21.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.4 | no trial data cached |
| Cardiogenic shock | 18 | 31.1 19.7–49.1ROR 31.7 · χ² 494 / p 9e-110 | 30.2 EB05 20.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.4 | no trial data cached |
| Emotional distress | 152 | 30.8 26.7–35.6ROR 37.3 · χ² 4,377 / p <1e-300 | 30.7 EB05 26.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.9 | no trial data cached |
| Disability | 24 | 29.9 20.1–44.3ROR 30.7 · χ² 641 / p 9e-142 | 29.2 EB05 20.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 | no trial data cached |
| Joint range of motion decreased | 16 | 29.5 18.1–47.9ROR 30.0 · χ² 412 / p 6e-92 | 28.6 EB05 18.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.9 | no trial data cached |
| Incorrect drug administration duration | 32 | 27.6 19.7–38.8ROR 28.7 · χ² 795 / p 3e-175 | 27.2 EB05 20.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 53.7 · 97% consumer | no trial data cached |
| Pericarditis | 18 | 26.6 16.8–42.0ROR 27.2 · χ² 418 / p 3e-93 | 25.9 EB05 17.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 | no trial data cached |
| Synovitis | 19 | 25.9 16.6–40.5ROR 26.5 · χ² 431 / p 5e-96 | 25.3 EB05 17.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.7 | no trial data cached |
| Renal failure acute | 44 | 25.2 18.9–33.6ROR 26.5 · χ² 999 / p 2e-219 | 24.9 EB05 19.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.5 | no trial data cached |
| Back disorder | 16 | 24.1 14.9–39.2ROR 24.6 · χ² 332 / p 2e-74 | 23.5 EB05 15.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.5 | no trial data cached |
| Pulmonary fibrosis | 18 | 23.2 14.7–36.6ROR 23.7 · χ² 360 / p 1e-80 | 22.7 EB05 15.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.2 | no trial data cached |
| Hip arthroplasty | 14 | 22.7 13.5–38.2ROR 23.1 · χ² 269 / p 9e-61 | 22.0 EB05 13.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 | no trial data cached |
| Irritable bowel syndrome | 19 | 21.9 14.0–34.2ROR 22.4 · χ² 358 / p 3e-80 | 21.4 EB05 14.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 | no trial data cached |
| Hepatotoxicity (liver damage) | 19 | 21.1 13.5–32.9ROR 21.6 · χ² 344 / p 4e-77 | 20.6 EB05 13.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.9 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 19 | 20.9 13.4–32.7ROR 21.4 · χ² 341 / p 2e-76 | 20.5 EB05 13.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 | no trial data cached |
| Joint injury | 18 | 20.7 13.1–32.8ROR 21.2 · χ² 319 / p 1e-71 | 20.2 EB05 13.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 | no trial data cached |
| Liver injury | 20 | 20.4 13.2–31.4ROR 20.8 · χ² 349 / p 3e-78 | 19.9 EB05 13.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 · 100% clinician | no trial data cached |
| Fibromyalgia | 19 | 19.3 12.3–30.1ROR 19.7 · χ² 311 / p 6e-70 | 18.8 EB05 12.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.5 | no trial data cached |
| Joint stiffness | 19 | 17.8 11.4–27.8ROR 18.2 · χ² 285 / p 2e-64 | 17.4 EB05 11.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.4 | no trial data cached |
| Anxiety | 193 | 16.7 14.7–18.9ROR 21.2 · χ² 2,863 / p <1e-300 | 16.6 EB05 14.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 | no trial data cached |
| Knee arthroplasty | 14 | 16.5 9.8–27.8ROR 16.8 · χ² 189 / p 2e-43 | 15.7 EB05 9.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 | no trial data cached |
| Wound | 18 | 15.9 10.1–25.2ROR 16.3 · χ² 238 / p 7e-54 | 15.3 EB05 9.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 | no trial data cached |
| Impaired healing | 21 | 15.7 10.3–24.0ROR 16.1 · χ² 276 / p 3e-62 | 15.3 EB05 10.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 13.1 · 100% clinician | no trial data cached |
| Type 2 diabetes mellitus | 20 | 14.6 9.5–22.5ROR 14.9 · χ² 240 / p 2e-54 | 14.0 EB05 9.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · 100% clinician | no trial data cached |
| Gait inability | 19 | 14.1 9.1–22.0ROR 14.4 · χ² 219 / p 7e-50 | 13.4 EB05 8.6 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 | no trial data cached |
| Arthropathy | 32 | 14.1 10.1–19.8ROR 14.6 · χ² 378 / p 2e-84 | 13.8 EB05 10.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 100% (drug 53%) · 97% 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 |
|---|---|---|---|---|---|---|
| Injury | 226 | 79.0 70.6–88.3ROR 107.1 · χ² 17,321 / p <1e-300 | 78.2 EB05 70.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.4 | no trial data cached |
| Renal failure (kidney failure) | 219 | 40.4 36.0–45.2ROR 54.0 · χ² 8,406 / p <1e-300 | 40.2 EB05 35.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.0 | no trial data cached |
| Anxiety | 193 | 16.7 14.7–18.9ROR 21.2 · χ² 2,863 / p <1e-300 | 16.6 EB05 14.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 | no trial data cached |
| Unevaluable event | 190 | 62.0 54.6–70.2ROR 79.4 · χ² 11,345 / p <1e-300 | 61.4 EB05 54.4 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 74.6 | no trial data cached |
| Fear | 174 | 159.0 139.2–181.7ROR 199.6 · χ² 27,024 / p <1e-300 | 155.3 EB05 136.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 148.1 | no trial data cached |
| Emotional distress | 152 | 30.8 26.7–35.6ROR 37.3 · χ² 4,377 / p <1e-300 | 30.7 EB05 26.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.9 | no trial data cached |
| Renal injury | 152 | 125.2 108.4–144.7ROR 152.2 · χ² 18,542 / p <1e-300 | 122.7 EB05 107.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.1 | no trial data cached |
| Stress | 128 | 43.9 37.4–51.5ROR 51.5 · χ² 5,329 / p <1e-300 | 43.5 EB05 37.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.1 | no trial data cached |
| Renal impairment | 125 | 36.8 31.3–43.3ROR 43.0 · χ² 4,331 / p <1e-300 | 36.6 EB05 31.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 | no trial data cached |
| Anhedonia | 121 | 112.9 95.7–133.3ROR 131.5 · χ² 13,268 / p <1e-300 | 110.5 EB05 94.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 85.8 | no trial data cached |
| Multi-organ failure | 112 | 158.1 133.0–188.0ROR 181.9 · χ² 17,231 / p <1e-300 | 153.0 EB05 130.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 108.5 | no trial data cached |
| Renal failure acute | 44 | 25.2 18.9–33.6ROR 26.5 · χ² 999 / p 2e-219 | 24.9 EB05 19.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.5 | no trial data cached |
| Musculoskeletal stiffness | 39 | 11.0 8.1–14.9ROR 11.4 · χ² 344 / p 4e-77 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · ♀ 100% (drug 53%) · 97% clinician | no trial data cached |
| Rheumatoid arthritis | 35 | 7.6 5.5–10.5ROR 7.9 · χ² 196 / p 9e-45 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 · ♀ 96% (drug 53%) · 94% clinician | no trial data cached |
| Drug dependence | 32 | 4.8 3.4–6.8ROR 5.0 · χ² 94 / p 1e-22 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 100% consumer | 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 injury, renal failure, anxiety, fear, emotional distress, renal injury. 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, 58 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.