Drug · FAERS side-effect profile with label screen
Phenylephrine Hydrochloride side effects: what 3,733 FDA adverse event reports show
Who reports
3,733 reports · 94% serious · 1,739 with death outcome · 86% 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 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 227 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 |
|---|---|---|---|---|---|---|
| Helicobacter infection | 873 | 489.5 460.1–520.9ROR 625.3 · calibrated p 5e-15 ✓ | 442.8 EB05 418.7 · IC025 +8.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 15.7 (11.5–21.4) | No label text to screen label has no adverse-reaction text | serious PRR 311.6 · 98% clinician | no trial data cached |
| Folliculitis | 877 | 485.0 455.9–516.0ROR 620.2 · calibrated p 6e-15 ✓ | 439.1 EB05 415.2 · IC025 +8.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 16.2 (11.8–22.1) | No label text to screen label has no adverse-reaction text | serious PRR 343.3 · 97% clinician | no trial data cached |
| Pemphigus | 1,040 | 477.2 451.4–504.4ROR 643.7 · calibrated p 4e-15 ✓ | 433.3 EB05 411.7 · IC025 +8.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 23.1 (16.4–32.5) | No label text to screen label has no adverse-reaction text | serious PRR 289.0 · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 629 | 367.7 341.2–396.3ROR 435.9 · calibrated p 3e-13 ✓ | 339.7 EB05 318.0 · IC025 +7.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 17.6 (12.0–25.9) | No label text to screen label has no adverse-reaction text | serious PRR 240.1 · 97% clinician | no trial data cached |
| Hand deformity | 851 | 363.5 341.6–386.9ROR 461.1 · calibrated p 1e-13 ✓ | 337.1 EB05 318.5 · IC025 +8.0 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 16.5 (12.0–22.7) | No label text to screen label has no adverse-reaction text | serious PRR 243.6 · 97% clinician | no trial data cached |
| Wound infection | 673 | 344.9 321.1–370.5ROR 414.2 · calibrated p 4e-13 ✓ | 320.4 EB05 300.6 · IC025 +7.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 16.4 (11.5–23.5) | No label text to screen label has no adverse-reaction text | serious PRR 228.6 · 97% clinician | no trial data cached |
| Bursitis | 687 | 315.5 294.0–338.5ROR 380.4 · calibrated p 1e-12 ✓ | 294.9 EB05 276.8 · IC025 +7.8 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 27.3 (17.3–43.1) | No label text to screen label has no adverse-reaction text | serious PRR 230.8 · 97% clinician | no trial data cached |
| Pericarditis | 945 | 314.1 296.4–332.9ROR 410.5 · calibrated p 5e-13 ✓ | 294.4 EB05 278.9 · IC025 +7.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 20.4 (14.6–28.6) | No label text to screen label has no adverse-reaction text | serious PRR 196.9 · 97% clinician | no trial data cached |
| Synovitis | 919 | 280.3 264.3–297.3ROR 363.2 · calibrated p 2e-12 ✓ | 264.4 EB05 250.4 · IC025 +7.8 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 21.1 (14.9–29.8) | No label text to screen label has no adverse-reaction text | serious PRR 183.7 · 98% clinician | no trial data cached |
| Back injury | 486 | 245.5 225.4–267.5ROR 279.2 · calibrated p 2e-11 ✓ | 232.3 EB05 215.4 · IC025 +7.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 61.2 (27.4–137.0) | No label text to screen label has no adverse-reaction text | serious PRR 204.9 · 98% clinician | no trial data cached |
| Joint range of motion decreased | 597 | 244.2 226.4–263.5ROR 286.7 · calibrated p 2e-11 ✓ | 231.5 EB05 216.3 · IC025 +7.5 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 12.9 (9.2–18.1) | No label text to screen label has no adverse-reaction text | serious PRR 196.0 · 97% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 942 | 229.8 217.0–243.4ROR 299.9 · calibrated p 1e-11 ✓ | 219.1 EB05 207.6 · IC025 +7.5 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 18.7 (13.6–25.9) | No label text to screen label has no adverse-reaction text | serious PRR 209.7 · 98% clinician | no trial data cached |
| Irritable bowel syndrome | 770 | 195.3 183.0–208.4ROR 241.4 · calibrated p 8e-11 ✓ | 187.3 EB05 176.5 · IC025 +7.3 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 17.1 (12.1–24.1) | No label text to screen label has no adverse-reaction text | serious PRR 157.4 · 97% clinician | no trial data cached |
| Wound | 928 | 180.4 170.3–191.1ROR 234.3 · calibrated p 1e-10 ✓ | 173.7 EB05 164.5 · IC025 +7.2 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 19.5 (14.0–27.2) | No label text to screen label has no adverse-reaction text | serious PRR 136.8 · 97% clinician | no trial data cached |
| Coeliac disease | 290 | 159.0 142.1–178.0ROR 171.3 · calibrated p 2e-9 ✓ | 152.7 EB05 138.5 · IC025 +6.7 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 54.8 (20.4–147.1) | No label text to screen label has no adverse-reaction text | serious PRR 126.8 · 96% clinician | no trial data cached |
| Obesity | 457 | 154.0 141.1–168.1ROR 173.7 · calibrated p 1e-9 ✓ | 148.7 EB05 137.6 · IC025 +6.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 24.7 (14.5–42.0) | No label text to screen label has no adverse-reaction text | serious PRR 114.2 · 98% clinician | no trial data cached |
| Liver injury | 678 | 150.7 140.5–161.6ROR 181.1 · calibrated p 1e-9 ✓ | 145.8 EB05 136.8 · IC025 +6.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 11.9 (8.8–16.2) | No label text to screen label has no adverse-reaction text | serious PRR 100.1 · 98% clinician | no trial data cached |
| Systemic lupus erythematosus | 949 | 144.0 136.1–152.4ROR 188.2 · calibrated p 7e-10 ✓ | 139.7 EB05 132.4 · IC025 +6.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 17.9 (13.1–24.6) | No label text to screen label has no adverse-reaction text | serious PRR 94.8 · 97% clinician | no trial data cached |
| Fibromyalgia | 645 | 142.5 132.6–153.1ROR 169.6 · calibrated p 2e-9 ✓ | 138.1 EB05 129.4 · IC025 +6.8 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 11.9 (8.7–16.3) | No label text to screen label has no adverse-reaction text | serious PRR 120.1 · 97% clinician | no trial data cached |
| Type 2 diabetes mellitus | 874 | 138.8 130.7–147.3ROR 177.1 · calibrated p 1e-9 ✓ | 134.8 EB05 127.4 · IC025 +6.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 13.5 (10.1–18.0) | No label text to screen label has no adverse-reaction text | serious PRR 93.9 · 97% clinician | no trial data cached |
| Taste disorder | 497 | 132.8 122.2–144.4ROR 151.5 · calibrated p 4e-9 ✓ | 128.9 EB05 119.7 · IC025 +6.7 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious PRR 171.8 · 98% clinician | no trial data cached |
| Contraindicated product administered | 747 | 132.6 124.2–141.6ROR 162.7 · calibrated p 2e-9 ✓ | 128.9 EB05 121.3 · IC025 +6.8 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 13.1 (9.7–17.9) | Reporting / coding artifact | serious PRR 106.4 · 97% clinician | no trial data cached |
| Impaired healing | 741 | 120.6 112.9–128.8ROR 147.6 · calibrated p 5e-9 ✓ | 117.5 EB05 110.6 · IC025 +6.7 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 14.0 (10.2–19.3) | Reporting / coding artifact | serious PRR 93.9 · 97% clinician | no trial data cached |
| Psoriatic arthropathy | 828 | 109.8 103.2–116.8ROR 138.1 · calibrated p 9e-9 ✓ | 107.3 EB05 101.3 · IC025 +6.5 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 19.6 (13.7–27.8) | No label text to screen label has no adverse-reaction text | serious PRR 89.2 · 97% clinician | no trial data cached |
| Liver function test increased | 439 | 109.8 100.4–120.0ROR 123.1 · calibrated p 2e-8 ✓ | 107.0 EB05 98.9 · IC025 +6.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 19.5 (12.0–31.7) | No label text to screen label has no adverse-reaction text | serious PRR 110.8 · 96% clinician | no trial data cached |
| Adverse reaction | 273 | 109.7 97.7–123.2ROR 117.7 · calibrated p 4e-8 ✓ | 106.7 EB05 96.5 · IC025 +6.3 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 41.3 (17.0–100.0) | Reporting / coding artifact | serious n=273 · 97% clinician | no trial data cached |
| Gait inability | 635 | 102.1 95.0–109.8ROR 121.2 · calibrated p 3e-8 ✓ | 99.9 EB05 93.5 · IC025 +6.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 25.3 (16.0–39.9) | No label text to screen label has no adverse-reaction text | serious PRR 82.2 · 97% clinician | no trial data cached |
| Pulmonary fibrosis | 347 | 96.6 87.2–106.9ROR 105.6 · calibrated p 8e-8 ✓ | 94.3 EB05 86.3 · IC025 +6.2 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 14.6 (9.1–23.4) | No label text to screen label has no adverse-reaction text | serious PRR 63.1 · 97% clinician | no trial data cached |
| Autoimmune disorder | 165 | 91.6 78.8–106.5ROR 95.5 · calibrated p 2e-7 ✓ | 89.1 EB05 78.3 · IC025 +5.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 13.9 (7.1–27.1) | No label text to screen label has no adverse-reaction text | serious PRR 63.6 · 98% clinician | no trial data cached |
| Epilepsy | 495 | 86.1 79.2–93.6ROR 98.1 · calibrated p 1e-7 ✓ | 84.4 EB05 78.4 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious PRR 56.1 · 97% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 176 | 84.2 72.8–97.4ROR 88.0 · calibrated p 3e-7 ✓ | 82.2 EB05 72.5 · IC025 +5.8 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | Lab value / disease marker | serious PRR 61.7 · 96% clinician | no trial data cached |
| Arthropathy | 881 | 83.8 79.0–88.9ROR 107.1 · calibrated p 7e-8 ✓ | 82.3 EB05 77.9 · IC025 +6.2 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 10.2 (8.0–13.2) | No label text to screen label has no adverse-reaction text | serious PRR 66.2 · 97% clinician | no trial data cached |
| C-reactive protein increased | 570 | 83.2 77.0–89.8ROR 96.7 · calibrated p 2e-7 ✓ | 81.6 EB05 76.2 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | Lab value / disease marker | serious PRR 56.2 · 97% clinician | no trial data cached |
| Night sweats | 502 | 82.7 76.2–89.8ROR 94.4 · calibrated p 2e-7 ✓ | 81.2 EB05 75.4 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious PRR 92.1 · 96% clinician | no trial data cached |
| Blood cholesterol increased | 718 | 81.7 76.4–87.3ROR 99.2 · calibrated p 1e-7 ✓ | 80.2 EB05 75.4 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | Lab value / disease marker | serious PRR 80.0 · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 695 | 81.3 76.0–87.1ROR 98.2 · calibrated p 1e-7 ✓ | 79.9 EB05 75.1 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious PRR 55.8 · 97% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 954 | 76.5 72.4–80.9ROR 100.1 · calibrated p 1e-7 ✓ | 75.3 EB05 71.4 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 23.3 (16.3–33.3) | No label text to screen label has no adverse-reaction text | serious PRR 62.7 · 97% clinician | no trial data cached |
| Laryngitis | 155 | 75.6 64.7–88.4ROR 78.6 · calibrated p 8e-7 ✓ | 73.9 EB05 64.6 · IC025 +5.6 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious n=154 · 97% clinician | no trial data cached |
| Therapeutic product effect decreased | 624 | 74.5 69.2–80.1ROR 88.0 · calibrated p 3e-7 ✓ | 73.3 EB05 68.6 · IC025 +6.0 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 9.1 (6.8–12.0) | Reporting / coding artifact | serious PRR 95.7 · 97% clinician | no trial data cached |
| Hepatic enzyme increased | 896 | 69.8 65.8–74.0ROR 89.5 · calibrated p 3e-7 ✓ | 68.8 EB05 65.1 · IC025 +5.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | Lab value / disease marker | serious PRR 65.7 · 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,333 | 8.0 7.7–8.4ROR 11.5 · calibrated p 0.020 ✓ | 8.0 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | Reporting / coding artifact | serious PRR 9.8 · 95% clinician | no trial data cached |
| Pemphigus | 1,040 | 477.2 451.4–504.4ROR 643.7 · calibrated p 4e-15 ✓ | 433.3 EB05 411.7 · IC025 +8.4 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 23.1 (16.4–32.5) | No label text to screen label has no adverse-reaction text | serious PRR 289.0 · 98% clinician | no trial data cached |
| Joint swelling | 1,007 | 44.0 41.7–46.5ROR 58.4 · calibrated p 5e-6 ✓ | 43.6 EB05 41.4 · IC025 +5.3 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious PRR 49.5 · 97% clinician | no trial data cached |
| Pain | 989 | 8.4 8.0–8.9ROR 10.8 · calibrated p 0.025 ✓ | 8.4 EB05 7.9 · IC025 +3.0 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · 96% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 988 | 3.9 3.7–4.1ROR 4.9 · calibrated p 0.249 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 1.1 (1.0–1.2) | Reporting / coding artifact | serious PRR 6.9 · 93% clinician | no trial data cached |
| Rheumatoid arthritis | 962 | 44.8 42.4–47.4ROR 58.6 · calibrated p 5e-6 ✓ | 44.4 EB05 42.1 · IC025 +5.3 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 10.9 (8.5–13.9) | No label text to screen label has no adverse-reaction text | serious PRR 35.8 · 97% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 954 | 76.5 72.4–80.9ROR 100.1 · calibrated p 1e-7 ✓ | 75.3 EB05 71.4 · IC025 +6.1 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 23.3 (16.3–33.3) | No label text to screen label has no adverse-reaction text | serious PRR 62.7 · 97% clinician | no trial data cached |
| Systemic lupus erythematosus | 949 | 144.0 136.1–152.4ROR 188.2 · calibrated p 7e-10 ✓ | 139.7 EB05 132.4 · IC025 +6.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 17.9 (13.1–24.6) | No label text to screen label has no adverse-reaction text | serious PRR 94.8 · 97% clinician | no trial data cached |
| Pericarditis | 945 | 314.1 296.4–332.9ROR 410.5 · calibrated p 5e-13 ✓ | 294.4 EB05 278.9 · IC025 +7.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 20.4 (14.6–28.6) | No label text to screen label has no adverse-reaction text | serious PRR 196.9 · 97% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 942 | 229.8 217.0–243.4ROR 299.9 · calibrated p 1e-11 ✓ | 219.1 EB05 207.6 · IC025 +7.5 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 18.7 (13.6–25.9) | No label text to screen label has no adverse-reaction text | serious PRR 209.7 · 98% clinician | no trial data cached |
| Maternal exposure during pregnancy | 940 | 56.3 53.2–59.5ROR 73.1 · calibrated p 1e-6 ✓ | 55.6 EB05 52.7 · IC025 +5.6 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 3.3 (2.8–3.8) | Reporting / coding artifact | serious PRR 46.6 · 96% clinician | no trial data cached |
| Wound | 928 | 180.4 170.3–191.1ROR 234.3 · calibrated p 1e-10 ✓ | 173.7 EB05 164.5 · IC025 +7.2 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 19.5 (14.0–27.2) | No label text to screen label has no adverse-reaction text | serious PRR 136.8 · 97% clinician | no trial data cached |
| Synovitis | 919 | 280.3 264.3–297.3ROR 363.2 · calibrated p 2e-12 ✓ | 264.4 EB05 250.4 · IC025 +7.8 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 21.1 (14.9–29.8) | No label text to screen label has no adverse-reaction text | serious PRR 183.7 · 98% clinician | no trial data cached |
| Hepatic enzyme increased | 896 | 69.8 65.8–74.0ROR 89.5 · calibrated p 3e-7 ✓ | 68.8 EB05 65.1 · IC025 +5.9 3/3 methods agree vs other alpha-1 Adrenergic Agonists: only this drug | Lab value / disease marker | serious PRR 65.7 · 98% clinician | no trial data cached |
| Arthropathy | 881 | 83.8 79.0–88.9ROR 107.1 · calibrated p 7e-8 ✓ | 82.3 EB05 77.9 · IC025 +6.2 3/3 methods agree vs other alpha-1 Adrenergic Agonists: PRR 10.2 (8.0–13.2) | No label text to screen label has no adverse-reaction text | serious PRR 66.2 · 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.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oxycodone Hydrochloride ↔ Drug Dependence.
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 pemphigus, joint swelling, pain, rheumatoid arthritis, infusion related reaction, systemic lupus erythematosus. 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, 267 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 2026-10-14. 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.