Drug · FAERS side-effect profile with label screen
Triprolidine side effects: what 181 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Triprolidine Hydrochloride (Histex)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
181 reports · 94% serious · 50 with death outcome · 93% female
openFDA FAERS counts, all years, deduplication not applied
Used for
temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes
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 1Lab value / disease marker 1No label text to screen 38
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 33 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 |
|---|---|---|---|---|---|---|
| Pemphigus | 120 | 1,129.1 1,016.2–1,254.6ROR 3,348.4 · χ² 132,896 / p <1e-300 | 947.7 EB05 813.7 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 687.4 · 96% clinician | no trial data cached |
| Pericarditis | 121 | 847.3 763.8–939.9ROR 2,554.0 · χ² 100,771 / p <1e-300 | 741.7 EB05 637.2 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 519.7 · 96% clinician | no trial data cached |
| Pulmonary fibrosis | 105 | 640.0 564.9–725.0ROR 1,522.8 · χ² 66,041 / p <1e-300 | 569.9 EB05 484.1 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 394.3 · 98% clinician | no trial data cached |
| Liver injury | 105 | 505.2 446.0–572.3ROR 1,201.8 · χ² 52,165 / p <1e-300 | 460.6 EB05 391.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 319.8 · 95% clinician | no trial data cached |
| Type 2 diabetes mellitus | 124 | 426.9 386.5–471.5ROR 1,353.4 · χ² 52,152 / p <1e-300 | 399.0 EB05 343.5 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 274.7 · 96% clinician | no trial data cached |
| Helicobacter infection | 37 | 421.9 316.3–562.8ROR 530.1 · χ² 15,072 / p <1e-300 | 345.2 EB05 261.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 272.3 | no trial data cached |
| Psoriatic arthropathy | 122 | 352.5 318.4–390.3ROR 1,079.3 · χ² 42,361 / p <1e-300 | 333.0 EB05 286.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 271.3 · 96% clinician | no trial data cached |
| Hand deformity | 38 | 337.4 254.2–447.9ROR 426.8 · χ² 12,383 / p <1e-300 | 287.7 EB05 218.8 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 224.3 | no trial data cached |
| Wound infection | 28 | 299.2 212.7–420.8ROR 353.8 · χ² 8,009 / p <1e-300 | 248.0 EB05 180.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 196.2 | no trial data cached |
| Folliculitis | 26 | 292.3 204.7–417.4ROR 341.2 · χ² 7,244 / p <1e-300 | 240.2 EB05 172.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 210.1 · 92% clinician | no trial data cached |
| Synovitis | 45 | 289.6 224.7–373.2ROR 385.0 · χ² 12,632 / p <1e-300 | 257.3 EB05 200.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 185.4 | no trial data cached |
| Oedema | 121 | 259.5 234.1–287.7ROR 780.9 · χ² 30,913 / p <1e-300 | 248.8 EB05 213.7 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 199.2 · 96% clinician | no trial data cached |
| Joint range of motion decreased | 29 | 251.9 180.4–351.7ROR 299.7 · χ² 6,987 / p <1e-300 | 215.7 EB05 157.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 196.4 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 39 | 202.4 153.3–267.4ROR 257.8 · χ² 7,612 / p <1e-300 | 184.0 EB05 140.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.4 | no trial data cached |
| Stomatitis (mouth sores) | 104 | 198.9 175.5–225.6ROR 466.3 · χ² 20,308 / p <1e-300 | 191.6 EB05 162.7 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 182.8 · 98% clinician | no trial data cached |
| Injury | 115 | 188.8 169.1–210.9ROR 516.1 · χ² 21,337 / p <1e-300 | 182.8 EB05 156.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.3 · 96% clinician | no trial data cached |
| Mobility decreased | 115 | 186.3 166.8–208.1ROR 509.2 · χ² 21,050 / p <1e-300 | 180.5 EB05 154.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 168.2 · 96% clinician | no trial data cached |
| Prescribed overdose | 31 | 185.9 134.9–256.2ROR 224.1 · χ² 5,513 / p <1e-300 | 166.7 EB05 123.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 194.1 | no trial data cached |
| Sleep disorder | 112 | 185.7 165.6–208.3ROR 485.6 · χ² 20,429 / p <1e-300 | 179.8 EB05 153.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 187.5 · 96% clinician | no trial data cached |
| Irritable bowel syndrome | 34 | 184.6 136.3–250.0ROR 227.1 · χ² 6,024 / p <1e-300 | 167.2 EB05 125.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.5 · 94% clinician | no trial data cached |
| Hypercholesterolaemia | 15 | 181.9 112.0–295.4ROR 198.2 · χ² 2,518 / p <1e-300 | 147.8 EB05 95.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 118.3 | no trial data cached |
| Wound | 43 | 179.4 138.2–233.0ROR 235.0 · χ² 7,451 / p <1e-300 | 166.1 EB05 128.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 130.8 | no trial data cached |
| Fibromyalgia | 36 | 172.0 128.3–230.4ROR 214.4 · χ² 5,947 / p <1e-300 | 157.5 EB05 118.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 138.5 | no trial data cached |
| Autoimmune disorder | 14 | 169.7 102.5–280.7ROR 183.8 · χ² 2,180 / p <1e-300 | 138.0 EB05 87.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.1 | no trial data cached |
| Prescribed underdose | 28 | 162.8 115.8–229.0ROR 192.5 · χ² 4,341 / p <1e-300 | 146.6 EB05 106.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 170.4 · 93% clinician | no trial data cached |
| Systemic lupus erythematosus | 45 | 147.5 114.5–190.1ROR 196.0 · χ² 6,407 / p <1e-300 | 138.8 EB05 108.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.7 | no trial data cached |
| Lower limb fracture | 24 | 145.8 100.4–211.7ROR 167.9 · χ² 3,306 / p <1e-300 | 130.7 EB05 92.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.1 · 92% clinician | no trial data cached |
| Laryngitis | 13 | 138.9 82.2–234.5ROR 149.5 · χ² 1,643 / p <1e-300 | 115.6 EB05 71.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Pregnancy | 24 | 137.6 94.8–199.8ROR 158.5 · χ² 3,119 / p <1e-300 | 124.1 EB05 87.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 123.3 · 92% clinician | no trial data cached |
| Sinusitis | 116 | 130.9 117.4–146.0ROR 362.7 · χ² 14,879 / p <1e-300 | 128.0 EB05 109.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 161.1 · 97% clinician | no trial data cached |
| Obesity | 18 | 130.8 84.4–202.9ROR 145.2 · χ² 2,190 / p <1e-300 | 115.0 EB05 77.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.0 | no trial data cached |
| Red blood cell sedimentation rate increased | 12 | 125.5 72.6–216.8ROR 134.3 · χ² 1,359 / p 8e-298 | 104.9 EB05 63.9 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 87.1 | no trial data cached |
| Foot deformity | 12 | 125.4 72.6–216.7ROR 134.2 · χ² 1,358 / p 1e-297 | 104.8 EB05 63.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.3 | no trial data cached |
| Dyspepsia (indigestion) | 102 | 120.6 106.0–137.1ROR 275.0 · χ² 12,020 / p <1e-300 | 117.8 EB05 99.9 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 146.7 · 98% clinician | no trial data cached |
| Sciatica | 16 | 117.0 73.2–186.8ROR 128.2 · χ² 1,725 / p <1e-300 | 102.9 EB05 67.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.3 | no trial data cached |
| Impaired healing | 33 | 116.5 85.6–158.7ROR 142.3 · χ² 3,667 / p <1e-300 | 109.2 EB05 81.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 86.3 · 94% clinician | no trial data cached |
| Joint swelling | 121 | 116.5 105.1–129.1ROR 349.4 · χ² 13,803 / p <1e-300 | 114.3 EB05 98.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 123.0 · 94% clinician | no trial data cached |
| Migraine | 95 | 116.1 101.1–133.4ROR 243.3 · χ² 10,765 / p <1e-300 | 113.4 EB05 95.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.3 · 98% clinician | no trial data cached |
| Joint dislocation | 10 | 110.1 60.3–201.2ROR 116.5 · χ² 974 / p 3e-214 | 91.4 EB05 53.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.9 | no trial data cached |
| Disability | 18 | 105.5 68.0–163.6ROR 117.0 · χ² 1,760 / p <1e-300 | 95.0 EB05 63.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.5 | 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 |
|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | 124 | 426.9 386.5–471.5ROR 1,353.4 · χ² 52,152 / p <1e-300 | 399.0 EB05 343.5 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 274.7 · 96% clinician | no trial data cached |
| Psoriatic arthropathy | 122 | 352.5 318.4–390.3ROR 1,079.3 · χ² 42,361 / p <1e-300 | 333.0 EB05 286.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 271.3 · 96% clinician | no trial data cached |
| Joint swelling | 121 | 116.5 105.1–129.1ROR 349.4 · χ² 13,803 / p <1e-300 | 114.3 EB05 98.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 123.0 · 94% clinician | no trial data cached |
| Oedema | 121 | 259.5 234.1–287.7ROR 780.9 · χ² 30,913 / p <1e-300 | 248.8 EB05 213.7 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 199.2 · 96% clinician | no trial data cached |
| Pericarditis | 121 | 847.3 763.8–939.9ROR 2,554.0 · χ² 100,771 / p <1e-300 | 741.7 EB05 637.2 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 519.7 · 96% clinician | no trial data cached |
| Pemphigus | 120 | 1,129.1 1,016.2–1,254.6ROR 3,348.4 · χ² 132,896 / p <1e-300 | 947.7 EB05 813.7 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 687.4 · 96% clinician | no trial data cached |
| Urticaria (hives) | 117 | 81.5 73.2–90.8ROR 228.7 · χ² 9,290 / p <1e-300 | 80.4 EB05 68.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 100.7 · 98% clinician | no trial data cached |
| Sinusitis | 116 | 130.9 117.4–146.0ROR 362.7 · χ² 14,879 / p <1e-300 | 128.0 EB05 109.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 161.1 · 97% clinician | no trial data cached |
| Mobility decreased | 115 | 186.3 166.8–208.1ROR 509.2 · χ² 21,050 / p <1e-300 | 180.5 EB05 154.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 168.2 · 96% clinician | no trial data cached |
| Injury | 115 | 188.8 169.1–210.9ROR 516.1 · χ² 21,337 / p <1e-300 | 182.8 EB05 156.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.3 · 96% clinician | no trial data cached |
| Weight increased (weight gain) | 114 | 59.3 53.0–66.3ROR 158.5 · χ² 6,544 / p <1e-300 | 58.7 EB05 50.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.7 · 98% clinician | no trial data cached |
| Sleep disorder | 112 | 185.7 165.6–208.3ROR 485.6 · χ² 20,429 / p <1e-300 | 179.8 EB05 153.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 187.5 · 96% clinician | no trial data cached |
| Gait disturbance | 111 | 67.0 59.7–75.3ROR 171.8 · χ² 7,217 / p <1e-300 | 66.3 EB05 56.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.6 · 95% clinician | no trial data cached |
| Liver injury | 105 | 505.2 446.0–572.3ROR 1,201.8 · χ² 52,165 / p <1e-300 | 460.6 EB05 391.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 319.8 · 95% clinician | no trial data cached |
| Pulmonary fibrosis | 105 | 640.0 564.9–725.0ROR 1,522.8 · χ² 66,041 / p <1e-300 | 569.9 EB05 484.1 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 394.3 · 98% 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 Triprolidine?
In FDA FAERS, the most frequently co-reported reaction terms for Triprolidine are type 2 diabetes mellitus, psoriatic arthropathy, joint swelling, oedema, pericarditis, pemphigus. 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 Triprolidine have an FDA boxed warning?
No. The FDA label retrieved for Triprolidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Triprolidine 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 cc466d33-cf3e-4f1c-a794-6d3d79903adf, effective 20240108; matched on
openfda.generic_name.exact:"TRIPROLIDINE 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, 73 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.