Drug · FAERS side-effect profile with label screen
Desloratadine side effects: what 10,660 FDA adverse event reports show
Drug class
Histamine-1 Receptor Antagonist
FDA label (Established Pharmacologic Class)
Who reports
10,660 reports · 78% serious · 591 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Desloratadine Tablets are a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older.
FDA label, Indications and Usage
What it is
Desloratadine Tablets are light blue, round, tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine Tablets also contain the following excipients: mi.
FDA label, Description section
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
Labeled (related wording) 2Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 9Not in label — unassessed 25
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 1,095 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 |
|---|---|---|---|---|---|---|
| Allergy test positive | 18 | 83.3 52.0–133.5ROR 83.5 · χ² 1,326 / p 1e-290 | 73.9 EB05 49.5 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Toxic shock syndrome | 23 | 74.1 48.9–112.3ROR 74.3 · χ² 1,528 / p <1e-300 | 67.6 EB05 47.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 64%) | no trial data cached |
| Endocrine ophthalmopathy | 25 | 61.3 41.2–91.2ROR 61.4 · χ² 1,380 / p <1e-300 | 57.0 EB05 40.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 64%) | no trial data cached |
| Electrocardiogram t wave peaked | 11 | 55.7 30.6–101.4ROR 55.8 · χ² 523 / p 6e-116 | 49.8 EB05 29.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Tenosynovitis stenosans | 15 | 54.2 32.4–90.5ROR 54.3 · χ² 711 / p 7e-157 | 49.6 EB05 31.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Chronic spontaneous urticaria | 22 | 40.0 26.3–61.0ROR 40.1 · χ² 782 / p 2e-172 | 38.1 EB05 26.5 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% clinician | no trial data cached |
| Hyperleukocytosis | 17 | 39.0 24.1–63.0ROR 39.0 · χ² 580 / p 2e-128 | 36.8 EB05 24.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Nasal ulcer | 30 | 37.5 26.2–53.8ROR 37.6 · χ² 1,011 / p 4e-222 | 36.1 EB05 26.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 64%) | no trial data cached |
| Prothrombin time abnormal | 12 | 34.7 19.6–61.4ROR 34.7 · χ² 353 / p 4e-79 | 32.5 EB05 19.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Troponin t increased | 22 | 34.6 22.7–52.7ROR 34.7 · χ² 673 / p 1e-148 | 33.1 EB05 23.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=22 · ♀ 0% (drug 64%) · 100% clinician | no trial data cached |
| Oedema genital | 10 | 31.1 16.7–58.1ROR 31.2 · χ² 258 / p 2e-58 | 29.1 EB05 16.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Mean cell haemoglobin increased | 25 | 30.1 20.3–44.6ROR 30.1 · χ² 663 / p 1e-146 | 29.0 EB05 20.7 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=25 · ♀ 100% (drug 64%) | no trial data cached |
| Ischaemic cerebral infarction | 16 | 27.4 16.7–44.8ROR 27.4 · χ² 375 / p 7e-84 | 26.2 EB05 17.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Giant cell arteritis | 11 | 27.1 15.0–49.2ROR 27.2 · χ² 248 / p 4e-56 | 25.6 EB05 15.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Skin oedema | 13 | 25.6 14.8–44.3ROR 25.7 · χ² 280 / p 4e-63 | 24.4 EB05 15.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| N-terminal prohormone brain natriuretic peptide increased | 18 | 25.6 16.1–40.7ROR 25.6 · χ² 395 / p 3e-88 | 24.6 EB05 16.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Livedo reticularis | 25 | 23.8 16.1–35.4ROR 23.9 · χ² 518 / p 5e-115 | 23.2 EB05 16.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 43% (drug 64%) | no trial data cached |
| Arthrodesis | 12 | 23.5 13.3–41.4ROR 23.5 · χ² 233 / p 6e-53 | 22.3 EB05 13.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Wrong patient received product | 32 | 22.2 15.7–31.5ROR 22.3 · χ² 621 / p 2e-137 | 21.7 EB05 16.1 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=32 · ♀ 41% (drug 64%) · 100% clinician | no trial data cached |
| Hypertrophic cardiomyopathy | 16 | 20.6 12.6–33.7ROR 20.6 · χ² 276 / p 3e-62 | 19.8 EB05 12.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Eyelid disorder | 23 | 19.8 13.2–29.9ROR 19.9 · χ² 389 / p 7e-87 | 19.3 EB05 13.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 64%) | no trial data cached |
| Alveolitis allergic | 10 | 19.0 10.2–35.3ROR 19.0 · χ² 151 / p 5e-35 | 17.5 EB05 9.1 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 10 | 18.4 9.9–34.4ROR 18.5 · χ² 147 / p 5e-34 | 17.0 EB05 8.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Dermatitis bullous | 66 | 18.2 14.3–23.2ROR 18.3 · χ² 1,046 / p 8e-230 | 17.9 EB05 14.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · 100% clinician | no trial data cached |
| Onycholysis | 14 | 17.9 10.6–30.2ROR 17.9 · χ² 205 / p 1e-46 | 17.0 EB05 10.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Conjunctivitis allergic | 13 | 17.6 10.2–30.4ROR 17.6 · χ² 186 / p 1e-42 | 16.6 EB05 9.6 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Fixed eruption | 14 | 16.4 9.7–27.7ROR 16.4 · χ² 186 / p 2e-42 | 15.4 EB05 9.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Tonic clonic movements | 10 | 15.3 8.2–28.5ROR 15.3 · χ² 119 / p 6e-28 | 13.5 EB05 6.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Rhinitis allergic | 34 | 15.2 10.8–21.2ROR 15.2 · χ² 432 / p 3e-96 | 14.8 EB05 10.9 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=31 | no trial data cached |
| Dermatitis exfoliative generalised | 26 | 15.0 10.2–22.0ROR 15.0 · χ² 323 / p 2e-72 | 14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 40% (drug 64%) | no trial data cached |
| Hyperparathyroidism secondary | 19 | 14.9 9.5–23.3ROR 14.9 · χ² 230 / p 3e-52 | 14.1 EB05 9.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Asthmatic crisis | 27 | 14.6 10.0–21.3ROR 14.7 · χ² 327 / p 3e-73 | 14.1 EB05 9.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 85% (drug 64%) | no trial data cached |
| Troponin i increased | 12 | 14.3 8.1–25.2ROR 14.3 · χ² 134 / p 2e-31 | 12.8 EB05 6.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Myoglobin blood increased | 11 | 14.2 7.8–25.7ROR 14.2 · χ² 121 / p 2e-28 | 12.5 EB05 6.5 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Recalled product administered | 62 | 13.9 10.9–17.9ROR 14.0 · χ² 727 / p 2e-160 | 13.7 EB05 11.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Blood immunoglobulin e increased | 17 | 13.8 8.6–22.2ROR 13.8 · χ² 188 / p 4e-43 | 12.9 EB05 7.9 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Hepatitis fulminant | 20 | 13.3 8.6–20.7ROR 13.3 · χ² 214 / p 8e-49 | 12.5 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Synovial cyst | 31 | 13.2 9.3–18.8ROR 13.2 · χ² 336 / p 3e-75 | 12.7 EB05 9.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 90% (drug 64%) | no trial data cached |
| Foreign body in throat | 20 | 13.0 8.4–20.2ROR 13.0 · χ² 209 / p 1e-47 | 12.2 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Electrocardiogram t wave abnormal | 10 | 12.7 6.8–23.7ROR 12.8 · χ² 96 / p 5e-23 | 10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious n=10 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 619 | 0.9 0.9–1.0ROR 0.9 · χ² 4 / p 0.023 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Fatigue (tiredness) | 614 | 1.6 1.4–1.7ROR 1.6 · χ² 126 / p 2e-29 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Nausea | 600 | 1.5 1.4–1.6ROR 1.5 · χ² 102 / p 3e-24 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Dyspnoea (shortness of breath) | 541 | 1.9 1.7–2.0ROR 1.9 · χ² 229 / p 6e-52 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Headache | 477 | 1.5 1.4–1.6ROR 1.5 · χ² 81 / p 1e-19 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Diarrhoea (diarrhea) | 459 | 1.4 1.3–1.5ROR 1.4 · χ² 55 / p 8e-14 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Dizziness | 450 | 1.8 1.6–1.9ROR 1.8 · χ² 156 / p 4e-36 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Pruritus (itching) | 435 | 2.3 2.1–2.5ROR 2.3 · χ² 311 / p 6e-70 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.3 | no trial data cached |
| Vomiting | 413 | 1.7 1.6–1.9ROR 1.8 · χ² 130 / p 2e-30 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Rash | 391 | 1.8 1.6–2.0ROR 1.8 · χ² 134 / p 3e-31 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Off label use (used outside approved label) | 343 | 0.8 0.7–0.9ROR 0.8 · χ² 23 / p 1e-6 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Pain | 325 | 1.0 0.9–1.2ROR 1.0 · χ² 0 / p 0.252 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Asthenia (weakness) | 325 | 1.7 1.5–1.9ROR 1.7 · χ² 95 / p 1e-22 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Pyrexia (fever) | 324 | 1.8 1.7–2.0ROR 1.9 · χ² 126 / p 2e-29 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 1.6 | no trial data cached |
| Arthralgia (joint pain) | 321 | 1.5 1.4–1.7ROR 1.5 · χ² 58 / p 1e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Toxic shock syndrome — n=23, PRR 74.1
- Endocrine ophthalmopathy — n=25, PRR 61.3
- Nasal ulcer — n=30, PRR 37.5
- Livedo reticularis — n=25, PRR 23.8
- Eyelid disorder — n=23, PRR 19.8
- Dermatitis bullous — n=66, PRR 18.2
- Dermatitis exfoliative generalised — n=26, PRR 15.0
- Asthmatic crisis — n=27, PRR 14.6
- Recalled product administered — n=62, PRR 13.9
- Hepatitis fulminant — n=20, PRR 13.3
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 Desloratadine?
In FDA FAERS, the most frequently co-reported reaction terms for Desloratadine are fatigue, nausea, dyspnoea, headache, diarrhoea, 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 Desloratadine have an FDA boxed warning?
No. The FDA label retrieved for Desloratadine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Desloratadine 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 21174c0f-9204-4c75-b6e6-2f9ada5b535d, effective 20260826; matched on
openfda.generic_name.exact:"DESLORATADINE") - 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, 1,135 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.