Drug · FAERS side-effect profile with label screen
Tetrahydrozoline side effects: what 281 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Tetrahydrozoline Hydrochloride (Medics Choice Eye Drops Original Redness Reliever)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
281 reports · 72% serious · 18 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
■ relieves redness of the eye due to minor eye irritations
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 30 strongest signals
Reporting / coding artifact 5No label text to screen 25
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. 6 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 | 73 | 380.5 312.1–463.8ROR 513.7 · χ² 27,131 / p <1e-300 | 344.3 EB05 283.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 448.1 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Tubulointerstitial nephritis | 80 | 320.1 265.8–385.5ROR 447.1 · χ² 25,042 / p <1e-300 | 296.1 EB05 245.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 254.7 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Impaired work ability | 81 | 282.9 235.3–340.1ROR 397.1 · χ² 22,409 / p <1e-300 | 264.3 EB05 219.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 287.6 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Frequent bowel movements | 88 | 244.9 205.8–291.3ROR 356.1 · χ² 21,087 / p <1e-300 | 231.8 EB05 193.9 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 300.1 · ♀ 3% (drug 42%) · 95% clinician | no trial data cached |
| Swollen tongue | 82 | 196.2 163.5–235.5ROR 276.7 · χ² 15,715 / p <1e-300 | 187.2 EB05 155.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 218.8 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Systemic lupus erythematosus | 87 | 184.0 154.4–219.1ROR 266.0 · χ² 15,636 / p <1e-300 | 176.5 EB05 147.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.1 · ♀ 7% (drug 42%) · 95% clinician | no trial data cached |
| Nightmare | 84 | 180.8 151.1–216.3ROR 257.4 · χ² 14,825 / p <1e-300 | 173.3 EB05 144.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 244.2 · ♀ 5% (drug 42%) · 93% clinician | no trial data cached |
| Accidental overdose | 84 | 171.9 143.7–205.7ROR 244.8 · χ² 14,093 / p <1e-300 | 165.1 EB05 137.5 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 224.8 · ♀ 3% (drug 42%) · 95% clinician | no trial data cached |
| Rectal haemorrhage | 86 | 149.1 125.0–177.9ROR 214.5 · χ² 12,508 / p <1e-300 | 144.1 EB05 120.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.1 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 88 | 143.0 120.2–170.0ROR 207.7 · χ² 12,268 / p <1e-300 | 138.5 EB05 115.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 175.3 · ♀ 6% (drug 42%) · 93% clinician | no trial data cached |
| Colitis ulcerative | 85 | 142.5 119.3–170.2ROR 203.8 · χ² 11,803 / p <1e-300 | 137.9 EB05 115.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 121.8 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Loss of personal independence in daily activities | 88 | 138.3 116.3–164.5ROR 201.0 · χ² 11,866 / p <1e-300 | 134.1 EB05 112.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.3 · ♀ 4% (drug 42%) · 95% clinician | no trial data cached |
| Eczema | 83 | 123.3 102.9–147.8ROR 174.6 · χ² 9,956 / p <1e-300 | 119.8 EB05 99.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 287.4 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Haematochezia (blood in stool) | 85 | 115.3 96.5–137.7ROR 164.8 · χ² 9,526 / p <1e-300 | 112.3 EB05 93.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 100.9 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Medication error | 84 | 113.1 94.5–135.3ROR 160.9 · χ² 9,232 / p <1e-300 | 110.2 EB05 91.8 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 145.9 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 87 | 106.6 89.5–127.0ROR 154.0 · χ² 9,010 / p <1e-300 | 104.1 EB05 87.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.7 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 85 | 97.2 81.4–116.1ROR 139.0 · χ² 8,015 / p <1e-300 | 95.1 EB05 79.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.9 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Stress | 86 | 89.3 74.9–106.5ROR 128.3 · χ² 7,440 / p <1e-300 | 87.5 EB05 73.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.9 · ♀ 2% (drug 42%) · 94% clinician | no trial data cached |
| Dysgeusia (altered taste) | 85 | 85.0 71.2–101.6ROR 121.5 · χ² 6,991 / p <1e-300 | 83.4 EB05 69.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 189.4 · ♀ 6% (drug 42%) · 93% clinician | no trial data cached |
| Arthritis | 82 | 77.7 64.8–93.3ROR 109.4 · χ² 6,152 / p <1e-300 | 76.3 EB05 63.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.3 · ♀ 2% (drug 42%) · 94% clinician | no trial data cached |
| Intentional product use issue | 88 | 74.7 62.8–88.9ROR 108.4 · χ² 6,349 / p <1e-300 | 73.5 EB05 61.5 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 87.5 · ♀ 7% (drug 42%) · 95% clinician | no trial data cached |
| Migraine | 86 | 67.7 56.8–80.7ROR 97.1 · χ² 5,605 / p <1e-300 | 66.7 EB05 55.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.6 · ♀ 2% (drug 42%) · 93% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 82 | 64.1 53.5–77.0ROR 90.2 · χ² 5,053 / p <1e-300 | 63.2 EB05 52.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.3 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Adverse drug reaction | 71 | 59.3 48.5–72.5ROR 79.0 · χ² 4,023 / p <1e-300 | 58.3 EB05 47.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 136.2 · ♀ 12% (drug 42%) · 93% clinician | no trial data cached |
| Palpitations (pounding heartbeat) | 84 | 53.6 44.8–64.1ROR 76.0 · χ² 4,305 / p <1e-300 | 53.0 EB05 44.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.1 · ♀ 5% (drug 42%) · 93% clinician | no trial data cached |
| Abdominal discomfort | 93 | 41.5 35.2–49.1ROR 61.6 · χ² 3,666 / p <1e-300 | 41.2 EB05 34.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.7 · ♀ 10% (drug 42%) · 95% clinician | no trial data cached |
| Inappropriate schedule of product administration | 92 | 38.9 32.9–45.9ROR 57.3 · χ² 3,382 / p <1e-300 | 38.5 EB05 32.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 75.1 · ♀ 7% (drug 42%) · 90% clinician | no trial data cached |
| Covid-19 | 85 | 35.9 30.0–42.8ROR 51.0 · χ² 2,869 / p <1e-300 | 35.6 EB05 29.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · ♀ 5% (drug 42%) · 94% clinician | no trial data cached |
| Cerebrovascular accident (stroke) | 81 | 35.6 29.6–42.7ROR 49.6 · χ² 2,707 / p <1e-300 | 35.3 EB05 29.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Eye irritation | 17 | 22.8 14.4–36.1ROR 24.2 · χ² 333 / p 1e-74 | 22.2 EB05 14.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.0 | 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 |
|---|---|---|---|---|---|---|
| Abdominal discomfort | 93 | 41.5 35.2–49.1ROR 61.6 · χ² 3,666 / p <1e-300 | 41.2 EB05 34.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.7 · ♀ 10% (drug 42%) · 95% clinician | no trial data cached |
| Inappropriate schedule of product administration | 92 | 38.9 32.9–45.9ROR 57.3 · χ² 3,382 / p <1e-300 | 38.5 EB05 32.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 75.1 · ♀ 7% (drug 42%) · 90% clinician | no trial data cached |
| Intentional product use issue | 88 | 74.7 62.8–88.9ROR 108.4 · χ² 6,349 / p <1e-300 | 73.5 EB05 61.5 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 87.5 · ♀ 7% (drug 42%) · 95% clinician | no trial data cached |
| Loss of personal independence in daily activities | 88 | 138.3 116.3–164.5ROR 201.0 · χ² 11,866 / p <1e-300 | 134.1 EB05 112.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.3 · ♀ 4% (drug 42%) · 95% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 88 | 143.0 120.2–170.0ROR 207.7 · χ² 12,268 / p <1e-300 | 138.5 EB05 115.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 175.3 · ♀ 6% (drug 42%) · 93% clinician | no trial data cached |
| Frequent bowel movements | 88 | 244.9 205.8–291.3ROR 356.1 · χ² 21,087 / p <1e-300 | 231.8 EB05 193.9 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 300.1 · ♀ 3% (drug 42%) · 95% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 87 | 106.6 89.5–127.0ROR 154.0 · χ² 9,010 / p <1e-300 | 104.1 EB05 87.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.7 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Systemic lupus erythematosus | 87 | 184.0 154.4–219.1ROR 266.0 · χ² 15,636 / p <1e-300 | 176.5 EB05 147.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.1 · ♀ 7% (drug 42%) · 95% clinician | no trial data cached |
| Migraine | 86 | 67.7 56.8–80.7ROR 97.1 · χ² 5,605 / p <1e-300 | 66.7 EB05 55.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.6 · ♀ 2% (drug 42%) · 93% clinician | no trial data cached |
| Stress | 86 | 89.3 74.9–106.5ROR 128.3 · χ² 7,440 / p <1e-300 | 87.5 EB05 73.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.9 · ♀ 2% (drug 42%) · 94% clinician | no trial data cached |
| Rectal haemorrhage | 86 | 149.1 125.0–177.9ROR 214.5 · χ² 12,508 / p <1e-300 | 144.1 EB05 120.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.1 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Covid-19 | 85 | 35.9 30.0–42.8ROR 51.0 · χ² 2,869 / p <1e-300 | 35.6 EB05 29.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · ♀ 5% (drug 42%) · 94% clinician | no trial data cached |
| Dysgeusia (altered taste) | 85 | 85.0 71.2–101.6ROR 121.5 · χ² 6,991 / p <1e-300 | 83.4 EB05 69.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 189.4 · ♀ 6% (drug 42%) · 93% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 85 | 97.2 81.4–116.1ROR 139.0 · χ² 8,015 / p <1e-300 | 95.1 EB05 79.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.9 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Haematochezia (blood in stool) | 85 | 115.3 96.5–137.7ROR 164.8 · χ² 9,526 / p <1e-300 | 112.3 EB05 93.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 100.9 · ♀ 2% (drug 42%) · 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 Tetrahydrozoline?
In FDA FAERS, the most frequently co-reported reaction terms for Tetrahydrozoline are abdominal discomfort, loss of personal independence in daily activities, tinnitus, frequent bowel movements, vertigo, 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 Tetrahydrozoline have an FDA boxed warning?
No. The FDA label retrieved for Tetrahydrozoline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tetrahydrozoline 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 e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be, effective 20251230; matched on
openfda.generic_name.exact:"TETRAHYDROZOLINE 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, 36 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.