Drug · FAERS side-effect profile with label screen
Naphazoline and Pheniramine side effects: what 1,879 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Naphazoline Hydrochloride And Pheniramine Maleate (Opcon-A)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,879 reports · 6% serious · 9 with death outcome · 71% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander
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 21 strongest signals
Reporting / coding artifact 6No label text to screen 15
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. 8 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 |
|---|---|---|---|---|---|---|
| Mydriasis | 470 | 410.9 379.0–445.4ROR 541.7 · χ² 184,755 / p <1e-300 | 389.4 EB05 360.7 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.5 · 97% consumer | no trial data cached |
| Eye irritation | 481 | 93.9 86.9–101.5ROR 124.5 · χ² 43,857 / p <1e-300 | 92.8 EB05 86.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.6 · 97% consumer | no trial data cached |
| Ocular hyperaemia | 169 | 39.2 33.9–45.3ROR 42.8 · χ² 6,240 / p <1e-300 | 38.9 EB05 34.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.3 · 94% consumer | no trial data cached |
| Eye pain | 186 | 36.5 31.8–41.8ROR 40.2 · χ² 6,376 / p <1e-300 | 36.2 EB05 32.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 · 97% consumer | no trial data cached |
| Eye discharge | 24 | 25.4 17.1–37.8ROR 25.7 · χ² 538 / p 3e-119 | 24.9 EB05 17.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 96% consumer | no trial data cached |
| Eye pruritus | 76 | 24.9 20.0–31.1ROR 25.9 · χ² 1,721 / p <1e-300 | 24.7 EB05 20.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.4 · 93% consumer | no trial data cached |
| Lacrimation increased | 67 | 24.3 19.2–30.7ROR 25.1 · χ² 1,469 / p <1e-300 | 24.1 EB05 19.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · 94% consumer | no trial data cached |
| Eyelid oedema | 23 | 21.2 14.1–31.9ROR 21.5 · χ² 423 / p 3e-94 | 20.9 EB05 14.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Ocular discomfort | 21 | 20.9 13.7–32.0ROR 21.1 · χ² 378 / p 2e-84 | 20.5 EB05 14.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Photophobia (light sensitivity) | 33 | 19.1 13.6–26.8ROR 19.4 · χ² 548 / p 2e-121 | 18.9 EB05 14.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · 97% consumer | no trial data cached |
| Vision blurred (blurred vision) | 227 | 18.0 15.9–20.3ROR 20.2 · χ² 3,637 / p <1e-300 | 17.9 EB05 16.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 · 98% consumer | no trial data cached |
| Eye swelling | 53 | 15.5 11.9–20.2ROR 15.9 · χ² 704 / p 2e-155 | 15.3 EB05 12.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 96% consumer | no trial data cached |
| Expired product administered | 46 | 15.0 11.3–19.9ROR 15.3 · χ² 586 / p 8e-130 | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Dry eye | 47 | 10.5 7.9–13.9ROR 10.7 · χ² 394 / p 5e-88 | 10.1 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · 91% consumer | no trial data cached |
| Drug administration error | 21 | 7.3 4.8–11.1ROR 7.4 · χ² 108 / p 2e-25 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | 95% consumer | no trial data cached |
| Burning sensation | 36 | 5.5 4.0–7.7ROR 5.6 · χ² 130 / p 2e-30 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · 94% consumer | no trial data cached |
| Eye disorder | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 30 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Product quality issue | 49 | 3.9 3.0–5.2ROR 4.0 · χ² 104 / p 8e-25 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 94% consumer | no trial data cached |
| Medication error | 20 | 3.9 2.5–6.0ROR 3.9 · χ² 40 / p 1e-10 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 90% consumer | no trial data cached |
| Wrong technique in drug usage process | 10 | 2.9 1.6–5.4ROR 2.9 · χ² 11 / p 5e-4 | 2.7 EB05 1.6 · IC025 +0.3 | Reporting / coding artifact | – | no trial data cached |
| Drug effect decreased | 11 | 2.2 1.2–3.9ROR 2.2 · χ² 6 / p 0.008 | 2.1 EB05 1.3 · IC025 +0.0 | Reporting / coding artifact | – | 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 |
|---|---|---|---|---|---|---|
| Eye irritation | 481 | 93.9 86.9–101.5ROR 124.5 · χ² 43,857 / p <1e-300 | 92.8 EB05 86.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.6 · 97% consumer | no trial data cached |
| Mydriasis | 470 | 410.9 379.0–445.4ROR 541.7 · χ² 184,755 / p <1e-300 | 389.4 EB05 360.7 · IC025 +8.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.5 · 97% consumer | no trial data cached |
| Vision blurred (blurred vision) | 227 | 18.0 15.9–20.3ROR 20.2 · χ² 3,637 / p <1e-300 | 17.9 EB05 16.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 · 98% consumer | no trial data cached |
| Eye pain | 186 | 36.5 31.8–41.8ROR 40.2 · χ² 6,376 / p <1e-300 | 36.2 EB05 32.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 · 97% consumer | no trial data cached |
| Ocular hyperaemia | 169 | 39.2 33.9–45.3ROR 42.8 · χ² 6,240 / p <1e-300 | 38.9 EB05 34.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.3 · 94% consumer | no trial data cached |
| Eye pruritus | 76 | 24.9 20.0–31.1ROR 25.9 · χ² 1,721 / p <1e-300 | 24.7 EB05 20.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.4 · 93% consumer | no trial data cached |
| Lacrimation increased | 67 | 24.3 19.2–30.7ROR 25.1 · χ² 1,469 / p <1e-300 | 24.1 EB05 19.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · 94% consumer | no trial data cached |
| Eye swelling | 53 | 15.5 11.9–20.2ROR 15.9 · χ² 704 / p 2e-155 | 15.3 EB05 12.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 96% consumer | no trial data cached |
| Product quality issue | 49 | 3.9 3.0–5.2ROR 4.0 · χ² 104 / p 8e-25 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 94% consumer | no trial data cached |
| Dry eye | 47 | 10.5 7.9–13.9ROR 10.7 · χ² 394 / p 5e-88 | 10.1 EB05 7.7 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · 91% consumer | no trial data cached |
| Expired product administered | 46 | 15.0 11.3–19.9ROR 15.3 · χ² 586 / p 8e-130 | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Burning sensation | 36 | 5.5 4.0–7.7ROR 5.6 · χ² 130 / p 2e-30 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · 94% consumer | no trial data cached |
| Photophobia (light sensitivity) | 33 | 19.1 13.6–26.8ROR 19.4 · χ² 548 / p 2e-121 | 18.9 EB05 14.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.6 · 97% consumer | no trial data cached |
| Eye discharge | 24 | 25.4 17.1–37.8ROR 25.7 · χ² 538 / p 3e-119 | 24.9 EB05 17.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 96% consumer | no trial data cached |
| Eyelid oedema | 23 | 21.2 14.1–31.9ROR 21.5 · χ² 423 / p 3e-94 | 20.9 EB05 14.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 Naphazoline and Pheniramine?
In FDA FAERS, the most frequently co-reported reaction terms for Naphazoline and Pheniramine are eye irritation, mydriasis, vision blurred, eye pain, ocular hyperaemia, eye pruritus. 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 and Pheniramine have an FDA boxed warning?
No. The FDA label retrieved for Naphazoline and Pheniramine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Naphazoline and Pheniramine 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 90a05c13-5b87-415b-9892-10d2edbc1943, effective 20231214; matched on
openfda.generic_name.exact:"NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE") - 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.