Levocetirizine Dihydrochloride side effects: what 23,873 FDA adverse event reports show
Drug class
Histamine h 1 -receptor antagonist
Who reports
23,873 reports · 40% serious · 986 with death outcome · 71% female
Used for
Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
What it is
Levocetirizine dihydrochloride, USP the active component of levocetirizine dihydrochloride tablets, USP is an orally active H 1 -receptor antagonist.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- 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. 1,112 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 |
|---|---|---|---|---|---|---|
| Amaurosis fugax | 224 | 233.0 201.1–269.8ROR 235.2 · χ² 40,581 / p <1e-300 | 180.9 EB05 161.9 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=224 · 93% clinician | not reported in cached trials |
| Urinary tract disorder | 194 | 39.5 34.3–45.6ROR 39.8 · χ² 6,933 / p <1e-300 | 37.7 EB05 33.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=192 · 93% clinician | not reported in cached trials |
| Haemorrhagic stroke | 304 | 35.3 31.5–39.5ROR 35.7 · χ² 9,702 / p <1e-300 | 33.9 EB05 30.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.6 · 91% clinician | not reported in cached trials |
| Trisomy 18 | 12 | 28.3 15.9–50.3ROR 28.3 · χ² 280 / p 4e-63 | 26.3 EB05 15.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Ocular discomfort | 242 | 20.0 17.6–22.7ROR 20.2 · χ² 4,250 / p <1e-300 | 19.5 EB05 17.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=225 | not reported in cached trials |
| Mast cell activation syndrome | 27 | 18.3 12.5–26.7ROR 18.3 · χ² 414 / p 2e-92 | 17.6 EB05 12.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=24 · 77% consumer | not reported in cached trials |
| Infusion site discharge | 32 | 16.7 11.8–23.7ROR 16.7 · χ² 449 / p 7e-100 | 16.2 EB05 11.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 71%) · 100% consumer | not reported in cached trials |
| Generalised oedema | 216 | 15.7 13.7–17.9ROR 15.8 · χ² 2,898 / p <1e-300 | 15.4 EB05 13.7 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.9 · 92% clinician | not reported in cached trials |
| Infusion site urticaria | 11 | 14.9 8.2–27.0ROR 14.9 · χ² 127 / p 1e-29 | 13.2 EB05 6.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=10 | not reported in cached trials |
| Febrile convulsion | 20 | 14.7 9.4–22.8ROR 14.7 · χ² 237 / p 8e-54 | 13.8 EB05 9.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Head discomfort | 265 | 13.4 11.9–15.1ROR 13.5 · χ² 2,983 / p <1e-300 | 13.2 EB05 11.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 | not reported in cached trials |
| Altered state of consciousness | 320 | 13.2 11.8–14.7ROR 13.4 · χ² 3,551 / p <1e-300 | 13.0 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 | not reported in cached trials |
| Nasal pruritus | 18 | 12.9 8.1–20.5ROR 12.9 · χ² 183 / p 5e-42 | 11.8 EB05 7.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Alopecia areata | 25 | 12.7 8.5–18.8ROR 12.7 · χ² 253 / p 2e-57 | 11.9 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 46% (drug 71%) · 100% clinician | not reported in cached trials |
| Infusion site pruritus | 42 | 12.0 8.8–16.2ROR 12.0 · χ² 406 / p 1e-90 | 11.5 EB05 8.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=34 · 71% consumer | not reported in cached trials |
| Infusion site rash | 18 | 11.7 7.4–18.7ROR 11.7 · χ² 164 / p 8e-38 | 10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Infusion site bruising | 28 | 11.7 8.1–17.0ROR 11.7 · χ² 260 / p 9e-59 | 10.9 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=18 · ♀ 100% (drug 71%) · 100% consumer | not reported in cached trials |
| Hangover | 46 | 11.6 8.6–15.4ROR 11.6 · χ² 427 / p 3e-95 | 11.1 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Conjunctivitis allergic | 19 | 11.5 7.3–18.1ROR 11.5 · χ² 170 / p 3e-39 | 10.4 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Infusion site swelling | 76 | 11.0 8.7–13.7ROR 11.0 · χ² 670 / p 6e-148 | 10.6 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=44 | not reported in cached trials |
| Infusion site mass | 13 | 10.8 6.3–18.7ROR 10.8 · χ² 105 / p 7e-25 | 9.1 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Foetal malformation | 13 | 10.5 6.1–18.2ROR 10.5 · χ² 102 / p 3e-24 | 8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 16 | 10.2 6.2–16.6ROR 10.2 · χ² 122 / p 1e-28 | 8.8 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Nail growth abnormal | 12 | 9.6 5.4–17.0ROR 9.6 · χ² 83 / p 3e-20 | 7.8 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Somnolence (drowsiness) | 2,151 | 9.5 9.1–9.9ROR 10.3 · χ² 16,297 / p <1e-300 | 9.4 EB05 9.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 85% consumer | NCT00264303: 31/438 (7.1%) on Levocetirizine Dihydrochloride |
| Seasonal allergy | 151 | 9.5 8.1–11.1ROR 9.5 · χ² 1,126 / p 5e-247 | 9.3 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=84 · 80% consumer | not reported in cached trials |
| Infusion site warmth | 12 | 8.8 5.0–15.6ROR 8.8 · χ² 75 / p 2e-18 | 7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Upper respiratory tract inflammation | 12 | 8.8 5.0–15.6ROR 8.8 · χ² 75 / p 3e-18 | 7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Photophobia (light sensitivity) | 184 | 8.7 7.6–10.1ROR 8.8 · χ² 1,240 / p 7e-272 | 8.5 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 | not reported in cached trials |
| Infusion site induration | 14 | 8.7 5.2–14.8ROR 8.7 · χ² 87 / p 5e-21 | 7.2 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Infusion site erythema | 77 | 8.2 6.6–10.3ROR 8.2 · χ² 477 / p 5e-106 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=49 | not reported in cached trials |
| Haematemesis (vomiting blood) | 235 | 8.2 7.2–9.3ROR 8.3 · χ² 1,462 / p <1e-300 | 8.0 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · 92% clinician | not reported in cached trials |
| Presyncope (near-fainting) | 223 | 8.2 7.2–9.3ROR 8.2 · χ² 1,382 / p <1e-300 | 8.0 EB05 7.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | not reported in cached trials |
| Postural orthostatic tachycardia syndrome | 12 | 8.1 4.6–14.3ROR 8.1 · χ² 67 / p 1e-16 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Rhinitis allergic | 40 | 8.0 5.8–10.9ROR 8.0 · χ² 235 / p 3e-53 | 7.4 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=28 | not reported in cached trials |
| Infusion site haemorrhage | 29 | 7.9 5.5–11.4ROR 7.9 · χ² 167 / p 2e-38 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=21 · 79% consumer | not reported in cached trials |
| Multiple allergies | 70 | 7.9 6.2–10.0ROR 7.9 · χ² 411 / p 1e-91 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=55 · 74% consumer | not reported in cached trials |
| Sneezing | 198 | 7.8 6.8–9.0ROR 7.9 · χ² 1,164 / p 2e-255 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 90% consumer | not reported in cached trials |
| Sinus pain | 20 | 7.7 4.9–11.9ROR 7.7 · χ² 108 / p 1e-25 | 6.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Upper-airway cough syndrome | 71 | 7.7 6.1–9.7ROR 7.7 · χ² 401 / p 1e-89 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=25 | 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 Levocetirizine Dihydrochloride 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 (1 of 40 signal terms matched).
- NCT00264303 — CUTE (Chronic Urticaria Treatment Evaluation) (N=886, PHASE4; 7 AE terms posted; arms: Levocetirizine 5 mg; Desloratadine 5 mg)
- NCT00621959 — A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With (N=596, PHASE4; 6 AE terms posted; arms: Placebo; LCTZ)
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) | 3,087 | 2.1 2.0–2.1ROR 2.2 · χ² 1,793 / p <1e-300 | 2.1 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | serious PRR 0.9 · 85% consumer | not reported in cached trials |
| Somnolence (drowsiness) | 2,151 | 9.5 9.1–9.9ROR 10.3 · χ² 16,297 / p <1e-300 | 9.4 EB05 9.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 85% consumer | NCT00264303: 31/438 (7.1%) on Levocetirizine Dihydrochloride |
| Fatigue (tiredness) | 1,744 | 2.0 1.9–2.1ROR 2.0 · χ² 866 / p 1e-190 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00264303: 19/438 (4.3%) on Levocetirizine Dihydrochloride |
| Headache | 1,387 | 1.9 1.8–2.0ROR 2.0 · χ² 656 / p 6e-145 | 1.9 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 3.3 | NCT00264303: 35/438 (8.0%) on Levocetirizine Dihydrochloride |
| Pruritus (itching) | 1,302 | 3.0 2.9–3.2ROR 3.1 · χ² 1,796 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | not reported in cached trials |
| Nausea | 1,148 | 1.3 1.2–1.4ROR 1.3 · χ² 72 / p 1e-17 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00264303: 5/438 (1.1%) on Levocetirizine Dihydrochloride |
| Dyspnoea (shortness of breath) | 1,119 | 1.7 1.6–1.8ROR 1.8 · χ² 359 / p 2e-80 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,058 | 1.4 1.4–1.5ROR 1.5 · χ² 149 / p 2e-34 | 1.4 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.3 | not reported in cached trials |
| Dizziness | 931 | 1.6 1.5–1.7ROR 1.7 · χ² 239 / p 4e-54 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.6 | not reported in cached trials |
| Cough | 834 | 2.6 2.5–2.8ROR 2.7 · χ² 844 / p 9e-186 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | not reported in cached trials |
| Rash | 816 | 1.7 1.5–1.8ROR 1.7 · χ² 214 / p 9e-49 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.5 | not reported in cached trials |
| Arthralgia (joint pain) | 805 | 1.7 1.6–1.8ROR 1.7 · χ² 239 / p 3e-54 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.1 | not reported in cached trials |
| Insomnia (trouble sleeping) | 781 | 2.6 2.4–2.8ROR 2.6 · χ² 758 / p 4e-167 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | not reported in cached trials |
| Off label use (used outside approved label) | 772 | 0.8 0.7–0.8ROR 0.8 · χ² 49 / p 1e-12 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Pain | 746 | 1.1 1.0–1.1ROR 1.1 · χ² 3 / p 0.043 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.5 | NCT00264303: 10/438 (2.3%) on Levocetirizine Dihydrochloride |
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.
- Amaurosis fugax — n=224, PRR 233.0
- Urinary tract disorder — n=194, PRR 39.5
- Haemorrhagic stroke — n=304, PRR 35.3
- Ocular discomfort — n=242, PRR 20.0
- Mast cell activation syndrome — n=27, PRR 18.3
- Infusion site discharge — n=32, PRR 16.7
- Febrile convulsion — n=20, PRR 14.7
- Head discomfort — n=265, PRR 13.4
- Altered state of consciousness — n=320, PRR 13.2
- Alopecia areata — n=25, PRR 12.7
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 Levocetirizine Dihydrochloride?
In FDA FAERS, the most frequently co-reported reaction terms for Levocetirizine Dihydrochloride are somnolence, fatigue, headache, pruritus, nausea, dyspnoea. 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 Levocetirizine Dihydrochloride have an FDA boxed warning?
No. The FDA label retrieved for Levocetirizine Dihydrochloride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Levocetirizine Dihydrochloride 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 163dcce7-4535-a596-e063-6394a90a634f, effective 20260813; matched on
openfda.generic_name.exact:"LEVOCETIRIZINE DIHYDROCHLORIDE") - 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, 1,152 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
LEVOCETIRIZINE DIHYDROCHLORIDE, results-bearing studies sorted by enrollment)
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.