Loratadine 10Mg side effects: what 488 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Loratadine (Allergy Relief)
Who reports
488 reports · 49% serious · 28 with death outcome · 71% female
Used for
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Boxed warning
None in the current label
Causality screen of the 7 strongest signals
What the badges mean
- 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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seasonal allergy | 13 | 39.4 23.1–67.5ROR 40.5 · χ² 449 / p 5e-100 | 37.4 EB05 23.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Dermatitis contact | 9 | 33.9 17.8–64.9ROR 34.6 · χ² 256 / p 8e-58 | 31.8 EB05 17.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Infusion site pain | 8 | 26.8 13.5–53.3ROR 27.3 · χ² 174 / p 5e-40 | 25.0 EB05 12.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Hospice care | 5 | 21.7 9.1–52.0ROR 21.9 · χ² 79 / p 3e-19 | 17.5 EB05 5.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.5 | no trial data cached |
| Insurance issue | 6 | 17.3 7.8–38.3ROR 17.5 · χ² 77 / p 1e-18 | 13.9 EB05 5.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.4 | no trial data cached |
| Multiple sclerosis relapse | 9 | 5.6 2.9–10.6ROR 5.7 · χ² 29 / p 3e-8 | 4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Dermatitis atopic | 5 | 4.3 1.8–10.2ROR 4.3 · χ² 10 / p 0.001 | 3.3 EB05 1.6 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Seasonal allergy | 13 | 39.4 23.1–67.5ROR 40.5 · χ² 449 / p 5e-100 | 37.4 EB05 23.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Multiple sclerosis relapse | 9 | 5.6 2.9–10.6ROR 5.7 · χ² 29 / p 3e-8 | 4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Dermatitis contact | 9 | 33.9 17.8–64.9ROR 34.6 · χ² 256 / p 8e-58 | 31.8 EB05 17.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Infusion site pain | 8 | 26.8 13.5–53.3ROR 27.3 · χ² 174 / p 5e-40 | 25.0 EB05 12.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Insurance issue | 6 | 17.3 7.8–38.3ROR 17.5 · χ² 77 / p 1e-18 | 13.9 EB05 5.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.4 | no trial data cached |
| Dermatitis atopic | 5 | 4.3 1.8–10.2ROR 4.3 · χ² 10 / p 0.001 | 3.3 EB05 1.6 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Hospice care | 5 | 21.7 9.1–52.0ROR 21.9 · χ² 79 / p 3e-19 | 17.5 EB05 5.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.5 | 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 Loratadine 10Mg?
In FDA FAERS, the most frequently co-reported reaction terms for Loratadine 10Mg are seasonal allergy, multiple sclerosis relapse, dermatitis contact, infusion site pain, insurance issue, dermatitis atopic. 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 Loratadine 10Mg have an FDA boxed warning?
No. The FDA label retrieved for Loratadine 10Mg has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Loratadine 10Mg 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 f0db3a13-43e6-4243-9a3a-7808ddd005e1, effective 20200616; matched on
openfda.generic_name.exact:"LORATADINE 10MG") - 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, 7 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.