Drug · FAERS side-effect profile with label screen
Naphazoline side effects: what 271 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Naphazoline Hydrochloride (Nazal)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
271 reports · 73% serious · 13 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for the temporary relief of nasal congestion due to the common cold, hay fever, or associated with sinusitis
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 29 strongest signals
Reporting / coding artifact 5No label text to screen 24
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. 0 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 |
|---|---|---|---|---|---|---|
| Impaired quality of life | 68 | 366.0 297.7–450.0ROR 487.7 · χ² 24,290 / p <1e-300 | 330.4 EB05 269.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 421.6 · ♀ 7% (drug 48%) · 96% clinician | no trial data cached |
| Tubulointerstitial nephritis | 76 | 314.1 259.4–380.3ROR 435.5 · χ² 23,330 / p <1e-300 | 290.0 EB05 239.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 248.1 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Impaired work ability | 71 | 256.1 209.6–312.9ROR 346.2 · χ² 17,743 / p <1e-300 | 238.8 EB05 195.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 258.5 · ♀ 4% (drug 48%) · 96% clinician | no trial data cached |
| Frequent bowel movements | 80 | 229.9 191.2–276.5ROR 325.3 · χ² 17,973 / p <1e-300 | 217.4 EB05 180.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 279.7 · ♀ 6% (drug 48%) · 96% clinician | no trial data cached |
| Swollen tongue | 75 | 185.4 152.9–224.8ROR 255.6 · χ² 13,557 / p <1e-300 | 176.7 EB05 145.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 205.2 · ♀ 3% (drug 48%) · 96% clinician | no trial data cached |
| Systemic lupus erythematosus | 77 | 168.2 139.1–203.2ROR 234.2 · χ² 12,621 / p <1e-300 | 161.1 EB05 133.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.2 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Nightmare | 75 | 166.7 137.4–202.1ROR 229.8 · χ² 12,180 / p <1e-300 | 159.6 EB05 131.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 223.5 · ♀ 3% (drug 48%) · 96% clinician | no trial data cached |
| Accidental overdose | 76 | 160.6 132.7–194.5ROR 222.5 · χ² 11,893 / p <1e-300 | 154.1 EB05 127.2 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 208.5 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Rectal haemorrhage | 77 | 137.9 114.1–166.7ROR 192.0 · χ² 10,333 / p <1e-300 | 133.2 EB05 110.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 116.7 · ♀ 5% (drug 48%) · 96% clinician | no trial data cached |
| Colitis ulcerative | 78 | 135.1 111.9–162.9ROR 189.0 · χ² 10,249 / p <1e-300 | 130.6 EB05 108.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.6 · ♀ 5% (drug 48%) · 95% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 77 | 129.2 106.9–156.1ROR 179.8 · χ² 9,673 / p <1e-300 | 125.1 EB05 103.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 157.3 · ♀ 7% (drug 48%) · 96% clinician | no trial data cached |
| Loss of personal independence in daily activities | 78 | 126.7 105.0–152.8ROR 177.2 · χ² 9,604 / p <1e-300 | 122.7 EB05 101.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 131.7 · ♀ 7% (drug 48%) · 94% clinician | no trial data cached |
| Eczema | 76 | 116.6 96.4–141.2ROR 161.5 · χ² 8,606 / p <1e-300 | 113.2 EB05 93.4 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 269.8 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Haematochezia (blood in stool) | 79 | 110.7 91.9–133.3ROR 155.6 · χ² 8,487 / p <1e-300 | 107.7 EB05 89.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.2 · ♀ 6% (drug 48%) · 96% clinician | no trial data cached |
| Medication error | 74 | 102.9 84.7–125.0ROR 141.0 · χ² 7,377 / p <1e-300 | 100.2 EB05 82.4 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 131.7 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 81 | 102.5 85.4–123.1ROR 145.6 · χ² 8,055 / p <1e-300 | 100.0 EB05 83.0 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.0 · ♀ 6% (drug 48%) · 94% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 77 | 91.0 75.3–109.9ROR 126.5 · χ² 6,776 / p <1e-300 | 88.9 EB05 73.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.3 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Stress | 76 | 81.5 67.4–98.7ROR 112.8 · χ² 5,980 / p <1e-300 | 79.9 EB05 65.9 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 106.8 · ♀ 3% (drug 48%) · 96% clinician | no trial data cached |
| Dysgeusia (altered taste) | 74 | 76.5 62.9–92.9ROR 104.7 · χ² 5,450 / p <1e-300 | 75.0 EB05 61.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.0 · ♀ 5% (drug 48%) · 96% clinician | no trial data cached |
| Arthritis | 76 | 74.4 61.5–90.1ROR 102.9 · χ² 5,448 / p <1e-300 | 73.0 EB05 60.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.3 · ♀ 5% (drug 48%) · 93% clinician | no trial data cached |
| Intentional product use issue | 79 | 69.3 57.6–83.5ROR 97.3 · χ² 5,268 / p <1e-300 | 68.2 EB05 56.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 80.6 · ♀ 5% (drug 48%) · 95% clinician | no trial data cached |
| Migraine | 79 | 64.2 53.3–77.4ROR 90.1 · χ² 4,874 / p <1e-300 | 63.3 EB05 52.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.2 · ♀ 5% (drug 48%) · 94% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 76 | 61.4 50.7–74.3ROR 84.8 · χ² 4,474 / p <1e-300 | 60.5 EB05 49.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.8 · ♀ 3% (drug 48%) · 96% clinician | no trial data cached |
| Adverse drug reaction | 59 | 50.9 40.6–63.8ROR 64.7 · χ² 2,845 / p <1e-300 | 50.1 EB05 40.2 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 116.0 · ♀ 4% (drug 48%) · 97% clinician | no trial data cached |
| Palpitations (pounding heartbeat) | 77 | 50.8 42.0–61.3ROR 70.4 · χ² 3,725 / p <1e-300 | 50.1 EB05 41.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.3 · ♀ 7% (drug 48%) · 96% clinician | no trial data cached |
| Inappropriate schedule of product administration | 87 | 38.0 31.9–45.1ROR 55.3 · χ² 3,118 / p <1e-300 | 37.6 EB05 31.5 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 71.8 · ♀ 10% (drug 48%) | no trial data cached |
| Abdominal discomfort | 81 | 37.4 31.1–44.9ROR 52.8 · χ² 2,853 / p <1e-300 | 37.1 EB05 30.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.4 · ♀ 6% (drug 48%) · 94% clinician | no trial data cached |
| Cerebrovascular accident (stroke) | 79 | 35.8 29.8–43.1ROR 50.1 · χ² 2,661 / p <1e-300 | 35.5 EB05 29.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · ♀ 6% (drug 48%) · 94% clinician | no trial data cached |
| Covid-19 | 80 | 34.9 29.0–41.9ROR 49.0 · χ² 2,619 / p <1e-300 | 34.6 EB05 28.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.1 · ♀ 8% (drug 48%) · 90% 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 |
|---|---|---|---|---|---|---|
| Inappropriate schedule of product administration | 87 | 38.0 31.9–45.1ROR 55.3 · χ² 3,118 / p <1e-300 | 37.6 EB05 31.5 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 71.8 · ♀ 10% (drug 48%) | no trial data cached |
| Abdominal discomfort | 81 | 37.4 31.1–44.9ROR 52.8 · χ² 2,853 / p <1e-300 | 37.1 EB05 30.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.4 · ♀ 6% (drug 48%) · 94% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 81 | 102.5 85.4–123.1ROR 145.6 · χ² 8,055 / p <1e-300 | 100.0 EB05 83.0 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.0 · ♀ 6% (drug 48%) · 94% clinician | no trial data cached |
| Covid-19 | 80 | 34.9 29.0–41.9ROR 49.0 · χ² 2,619 / p <1e-300 | 34.6 EB05 28.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.1 · ♀ 8% (drug 48%) · 90% clinician | no trial data cached |
| Frequent bowel movements | 80 | 229.9 191.2–276.5ROR 325.3 · χ² 17,973 / p <1e-300 | 217.4 EB05 180.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 279.7 · ♀ 6% (drug 48%) · 96% clinician | no trial data cached |
| Cerebrovascular accident (stroke) | 79 | 35.8 29.8–43.1ROR 50.1 · χ² 2,661 / p <1e-300 | 35.5 EB05 29.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · ♀ 6% (drug 48%) · 94% clinician | no trial data cached |
| Migraine | 79 | 64.2 53.3–77.4ROR 90.1 · χ² 4,874 / p <1e-300 | 63.3 EB05 52.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.2 · ♀ 5% (drug 48%) · 94% clinician | no trial data cached |
| Intentional product use issue | 79 | 69.3 57.6–83.5ROR 97.3 · χ² 5,268 / p <1e-300 | 68.2 EB05 56.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 80.6 · ♀ 5% (drug 48%) · 95% clinician | no trial data cached |
| Haematochezia (blood in stool) | 79 | 110.7 91.9–133.3ROR 155.6 · χ² 8,487 / p <1e-300 | 107.7 EB05 89.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.2 · ♀ 6% (drug 48%) · 96% clinician | no trial data cached |
| Loss of personal independence in daily activities | 78 | 126.7 105.0–152.8ROR 177.2 · χ² 9,604 / p <1e-300 | 122.7 EB05 101.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 131.7 · ♀ 7% (drug 48%) · 94% clinician | no trial data cached |
| Colitis ulcerative | 78 | 135.1 111.9–162.9ROR 189.0 · χ² 10,249 / p <1e-300 | 130.6 EB05 108.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.6 · ♀ 5% (drug 48%) · 95% clinician | no trial data cached |
| Palpitations (pounding heartbeat) | 77 | 50.8 42.0–61.3ROR 70.4 · χ² 3,725 / p <1e-300 | 50.1 EB05 41.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.3 · ♀ 7% (drug 48%) · 96% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 77 | 91.0 75.3–109.9ROR 126.5 · χ² 6,776 / p <1e-300 | 88.9 EB05 73.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.3 · ♀ 3% (drug 48%) · 95% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 77 | 129.2 106.9–156.1ROR 179.8 · χ² 9,673 / p <1e-300 | 125.1 EB05 103.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 157.3 · ♀ 7% (drug 48%) · 96% clinician | no trial data cached |
| Rectal haemorrhage | 77 | 137.9 114.1–166.7ROR 192.0 · χ² 10,333 / p <1e-300 | 133.2 EB05 110.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 116.7 · ♀ 5% (drug 48%) · 96% 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 Naphazoline?
In FDA FAERS, the most frequently co-reported reaction terms for Naphazoline are abdominal discomfort, vertigo, covid-19, frequent bowel movements, cerebrovascular accident, migraine. 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 Naphazoline have an FDA boxed warning?
No. The FDA label retrieved for Naphazoline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Naphazoline 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 4d4043f8-5ed3-4027-beb6-687db1308202, effective 20231206; matched on
openfda.generic_name.exact:"NAPHAZOLINE HYDROCHLORIDE") - 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, 29 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.