Drug · FAERS side-effect profile with label screen
Loratadine Tablet side effects: what 53,313 FDA adverse event reports show
Drug class
Not stated in label
Who reports
53,313 reports · 37% serious · 1,632 with death outcome · 69% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat
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 11No label text to screen 29
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,128 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 |
|---|---|---|---|---|---|---|
| Failure of child resistant mechanism for pharmaceutical product | 61 | 62.6 47.8–82.1ROR 62.7 · calibrated p 5e-6 ✓ | 53.2 EB05 42.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | not reported in cached trials |
| Accidental exposure to product by child | 566 | 35.5 32.6–38.7ROR 35.9 · calibrated p 1e-4 ✓ | 32.6 EB05 30.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | ♀ 47% (drug 69%) · 76% consumer | not reported in cached trials |
| Chronic spontaneous urticaria | 76 | 29.1 23.0–36.7ROR 29.1 · calibrated p 4e-4 ✓ | 26.9 EB05 22.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=74 | not reported in cached trials |
| Inappropriate prescribing | 34 | 22.6 16.0–31.9ROR 22.6 · calibrated p 0.002 ✓ | 21.2 EB05 15.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Product package associated injury | 76 | 13.9 11.1–17.5ROR 13.9 · calibrated p 0.010 ✓ | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Extra dose administered | 1,212 | 12.3 11.6–13.0ROR 12.6 · calibrated p 0.014 ✓ | 11.9 EB05 11.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · 81% consumer | not reported in cached trials |
| Patient dissatisfaction with treatment | 56 | 11.9 9.2–15.6ROR 12.0 · calibrated p 0.019 ✓ | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 0% (drug 69%) · 100% consumer | not reported in cached trials |
| Butterfly rash | 28 | 11.3 7.7–16.4ROR 11.3 · calibrated p 0.026 ✓ | 10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 100% (drug 69%) · 100% clinician | not reported in cached trials |
| Drug effect delayed | 121 | 10.6 8.9–12.7ROR 10.6 · calibrated p 0.027 ✓ | 10.2 EB05 8.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Allergy to animal | 27 | 10.4 7.1–15.2ROR 10.4 · calibrated p 0.034 ✓ | 9.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | not reported in cached trials |
| Rhinitis allergic | 94 | 8.5 6.9–10.4ROR 8.5 · calibrated p 0.058 | 8.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=80 | not reported in cached trials |
| Nephrogenic anaemia | 94 | 8.0 6.6–9.9ROR 8.1 · calibrated p 0.068 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=94 | not reported in cached trials |
| Seasonal allergy | 274 | 7.8 6.9–8.7ROR 7.8 · calibrated p 0.073 | 7.6 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=132 · 72% consumer | not reported in cached trials |
| Expired product administered | 639 | 7.7 7.1–8.3ROR 7.8 · calibrated p 0.073 | 7.5 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=24 · 94% consumer | not reported in cached trials |
| Acute sinusitis | 33 | 7.7 5.4–10.8ROR 7.7 · calibrated p 0.084 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 | not reported in cached trials |
| Pre-existing condition improved | 111 | 7.0 5.8–8.5ROR 7.0 · calibrated p 0.100 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 | not reported in cached trials |
| Infusion site discharge | 30 | 7.0 4.9–10.0ROR 7.0 · calibrated p 0.109 | 6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | not reported in cached trials |
| Nasal dryness | 108 | 6.9 5.7–8.3ROR 6.9 · calibrated p 0.106 | 6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 86% consumer | not reported in cached trials |
| Cholecystitis chronic | 113 | 6.6 5.5–8.0ROR 6.7 · calibrated p 0.117 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 100% (drug 69%) | not reported in cached trials |
| Essential hypertension | 43 | 6.6 4.9–9.0ROR 6.6 · calibrated p 0.123 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 69%) | not reported in cached trials |
| Sinus pain | 38 | 6.6 4.8–9.0ROR 6.6 · calibrated p 0.127 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 100% (drug 69%) | not reported in cached trials |
| Hyperparathyroidism secondary | 41 | 6.5 4.7–8.8ROR 6.5 · calibrated p 0.132 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 | not reported in cached trials |
| Product packaging difficult to open | 40 | 6.5 4.7–8.8ROR 6.5 · calibrated p 0.132 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Upper-airway cough syndrome | 132 | 6.4 5.4–7.6ROR 6.4 · calibrated p 0.127 | 6.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=65 | not reported in cached trials |
| Multiple allergies | 125 | 6.3 5.3–7.6ROR 6.4 · calibrated p 0.131 | 6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 | not reported in cached trials |
| Infusion site infection | 35 | 6.2 4.4–8.6ROR 6.2 · calibrated p 0.151 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · 100% consumer | not reported in cached trials |
| Expired drug administered | 77 | 6.1 4.9–7.6ROR 6.1 · calibrated p 0.148 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Incorrect dosage administered | 75 | 6.1 4.8–7.6ROR 6.1 · calibrated p 0.149 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | 71% consumer | not reported in cached trials |
| Infusion site haemorrhage | 47 | 5.8 4.3–7.7ROR 5.8 · calibrated p 0.174 | 5.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · 77% consumer | not reported in cached trials |
| Ear congestion | 39 | 5.7 4.2–7.9ROR 5.7 · calibrated p 0.178 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 100% (drug 69%) | not reported in cached trials |
| Drug effect incomplete | 520 | 5.6 5.2–6.1ROR 5.7 · calibrated p 0.175 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | 95% consumer | not reported in cached trials |
| Anxiety disorder | 46 | 5.4 4.1–7.3ROR 5.4 · calibrated p 0.200 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 69%) | not reported in cached trials |
| Sneezing | 302 | 5.4 4.8–6.0ROR 5.4 · calibrated p 0.197 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · 80% consumer | not reported in cached trials |
| Otitis media | 44 | 5.3 3.9–7.1ROR 5.3 · calibrated p 0.216 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · 100% clinician | not reported in cached trials |
| Paranasal sinus discomfort | 50 | 5.3 4.0–7.0ROR 5.3 · calibrated p 0.215 | 5.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 73% consumer | not reported in cached trials |
| Infusion site pruritus | 41 | 5.2 3.8–7.1ROR 5.2 · calibrated p 0.221 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | 71% consumer | not reported in cached trials |
| Device infusion issue | 32 | 5.2 3.7–7.4ROR 5.2 · calibrated p 0.228 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Chronic sinusitis | 48 | 5.1 3.8–6.8ROR 5.1 · calibrated p 0.234 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 100% (drug 69%) | not reported in cached trials |
| Therapeutic response unexpected | 566 | 5.0 4.6–5.4ROR 5.0 · calibrated p 0.231 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 90% consumer | not reported in cached trials |
| Drug administered to patient of inappropriate age | 90 | 4.9 4.0–6.1ROR 4.9 · calibrated p 0.248 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Loratadine Tablet as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00979901 — Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED) (N=1577, PHASE3; 1 AE terms posted; arms: Placebo; Montelukast 10mg; Loratadine 10mg; Montelukast 10 mg + Loratadine 10 mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 8,106 | 2.4 2.4–2.5ROR 2.7 · calibrated p 0.738 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 · 90% consumer | not reported in cached trials |
| Fatigue (tiredness) | 3,265 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.768 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Nausea | 2,994 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.657 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Headache | 2,804 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.834 | 1.8 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,343 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.611 | 1.4 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,280 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.715 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Off label use (used outside approved label) | 2,231 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.314 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 72% consumer | not reported in cached trials |
| Dizziness | 2,135 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.780 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Pain | 2,046 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.522 | 1.3 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | not reported in cached trials |
| Pruritus (itching) | 1,732 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.849 | 1.8 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
| Rash | 1,731 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.701 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Somnolence (drowsiness) | 1,518 | 3.0 2.8–3.1ROR 3.0 · calibrated p 0.613 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 · 76% consumer | not reported in cached trials |
| Cough | 1,512 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.970 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
| Vomiting | 1,438 | 1.2 1.1–1.3ROR 1.2 · calibrated p 0.449 | 1.2 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | not reported in cached trials |
| Arthralgia (joint pain) | 1,421 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.548 | 1.3 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
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 Tablet?
In FDA FAERS, the most frequently co-reported reaction terms for Loratadine Tablet are fatigue, nausea, headache, diarrhoea, dyspnoea, dizziness. 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 Tablet have an FDA boxed warning?
No. The FDA label retrieved for Loratadine Tablet has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Loratadine Tablet 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 0d74af21-3ef7-418b-a2ef-78737b0af288, effective 20250613; matched on
openfda.generic_name.exact:"LORATADINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,168 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 - ClinicalTrials.gov API v2 (query
LORATADINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.