Drug · FAERS side-effect profile with label screen
Laronidase side effects: what 862 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
862 reports · 64% serious · 70 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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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 4Lab value / disease marker 3No label text to screen 33
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. 118 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 |
|---|---|---|---|---|---|---|
| Poor venous access | 101 | 50.8 41.9–61.7ROR 52.1 · χ² 4,837 / p <1e-300 | 49.9 EB05 42.2 · IC025 +5.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Device related infection | 62 | 20.7 16.2–26.6ROR 21.0 · χ² 1,142 / p 2e-250 | 20.5 EB05 16.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 59 | 19.3 15.0–24.9ROR 19.6 · χ² 1,004 / p 1e-220 | 19.1 EB05 15.4 · IC025 +3.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Carpal tunnel syndrome | 47 | 17.3 13.0–23.0ROR 17.5 · χ² 702 / p 5e-155 | 17.1 EB05 13.3 · IC025 +3.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory disorder | 83 | 14.3 11.5–17.7ROR 14.5 · χ² 1,009 / p 9e-222 | 14.1 EB05 11.7 · IC025 +3.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory distress | 76 | 14.2 11.4–17.7ROR 14.4 · χ² 917 / p 8e-202 | 14.0 EB05 11.5 · IC025 +3.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Mitral valve incompetence | 29 | 13.2 9.2–19.0ROR 13.3 · χ² 315 / p 1e-70 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Ear infection | 67 | 13.0 10.3–16.5ROR 13.2 · χ² 730 / p 4e-161 | 12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Sleep apnoea syndrome | 45 | 12.1 9.1–16.2ROR 12.3 · χ² 448 / p 1e-99 | 11.8 EB05 9.0 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Body temperature increased | 48 | 12.1 9.1–16.0ROR 12.2 · χ² 476 / p 7e-106 | 11.8 EB05 9.1 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Spinal disorder | 21 | 11.4 7.4–17.5ROR 11.5 · χ² 189 / p 3e-43 | 10.5 EB05 6.9 · IC025 +2.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Secretion discharge | 27 | 11.3 7.7–16.4ROR 11.3 · χ² 242 / p 8e-55 | 10.6 EB05 7.3 · IC025 +2.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Hepatomegaly | 21 | 11.0 7.1–16.8ROR 11.0 · χ² 180 / p 3e-41 | 10.0 EB05 6.6 · IC025 +2.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Post procedural complication | 39 | 10.4 7.6–14.3ROR 10.5 · χ² 323 / p 1e-72 | 9.9 EB05 7.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Respiratory tract infection | 51 | 10.1 7.7–13.3ROR 10.2 · χ² 410 / p 2e-91 | 9.7 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Glaucoma | 37 | 9.9 7.2–13.6ROR 10.0 · χ² 287 / p 1e-64 | 9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Bronchospasm (airway tightening) | 26 | 9.4 6.4–13.7ROR 9.4 · χ² 186 / p 1e-42 | 8.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Oxygen saturation decreased | 98 | 9.0 7.4–11.0ROR 9.2 · χ² 694 / p 3e-153 | 8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Pallor | 46 | 8.7 6.5–11.6ROR 8.8 · χ² 305 / p 1e-68 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Tachypnoea | 22 | 8.4 5.5–12.7ROR 8.4 · χ² 135 / p 1e-31 | 7.4 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Joint dislocation | 17 | 8.3 5.2–13.4ROR 8.3 · χ² 102 / p 3e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Hernia | 31 | 8.3 5.8–11.8ROR 8.4 · χ² 192 / p 7e-44 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Device occlusion | 22 | 8.1 5.4–12.4ROR 8.2 · χ² 131 / p 1e-30 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Sars-cov-2 test positive | 21 | 8.1 5.3–12.4ROR 8.1 · χ² 124 / p 5e-29 | 7.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Obstructive airways disorder | 17 | 7.8 4.9–12.6ROR 7.9 · χ² 95 / p 1e-22 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pyrexia (fever) | 513 | 7.6 7.0–8.3ROR 8.6 · χ² 2,994 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Viral infection | 48 | 7.4 5.6–9.9ROR 7.5 · χ² 261 / p 5e-59 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory arrest | 39 | 7.2 5.3–9.9ROR 7.3 · χ² 203 / p 3e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Cardio-respiratory arrest | 56 | 6.9 5.3–8.9ROR 6.9 · χ² 274 / p 7e-62 | 6.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory failure | 94 | 6.6 5.4–8.1ROR 6.8 · χ² 445 / p 5e-99 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pharyngitis | 16 | 6.6 4.1–10.8ROR 6.6 · χ² 71 / p 2e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Blindness | 51 | 6.4 4.9–8.5ROR 6.5 · χ² 230 / p 4e-52 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Cardiomegaly | 15 | 6.2 3.8–10.3ROR 6.2 · χ² 61 / p 3e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Aspiration | 13 | 6.2 3.6–10.6ROR 6.2 · χ² 51 / p 4e-13 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Face oedema | 20 | 6.1 3.9–9.4ROR 6.1 · χ² 80 / p 2e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Infusion site pain | 15 | 6.0 3.6–10.0ROR 6.1 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Influenza | 131 | 6.0 5.1–7.1ROR 6.2 · χ² 547 / p 3e-121 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Infusion related reaction (reaction during infusion) | 75 | 5.8 4.7–7.3ROR 5.9 · χ² 297 / p 7e-67 | 5.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Complication associated with device | 14 | 5.5 3.2–9.2ROR 5.5 · χ² 46 / p 5e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Intentional dose omission | 28 | 5.3 3.6–7.6ROR 5.3 · χ² 93 / p 3e-22 | 4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | – | 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 |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 513 | 7.6 7.0–8.3ROR 8.6 · χ² 2,994 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pneumonia (lung infection) | 245 | 3.9 3.5–4.4ROR 4.1 · χ² 533 / p 3e-118 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Cough | 185 | 3.4 3.0–3.9ROR 3.5 · χ² 315 / p 7e-71 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Influenza | 131 | 6.0 5.1–7.1ROR 6.2 · χ² 547 / p 3e-121 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Inappropriate schedule of product administration | 118 | 3.4 2.9–4.1ROR 3.5 · χ² 203 / p 3e-46 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Urticaria (hives) | 118 | 3.6 3.1–4.4ROR 3.7 · χ² 226 / p 2e-51 | 3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Nasopharyngitis (common cold) | 106 | 3.0 2.4–3.6ROR 3.0 · χ² 136 / p 1e-31 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Disease progression | 102 | 4.5 3.7–5.4ROR 4.5 · χ² 271 / p 4e-61 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Poor venous access | 101 | 50.8 41.9–61.7ROR 52.1 · χ² 4,837 / p <1e-300 | 49.9 EB05 42.2 · IC025 +5.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Oxygen saturation decreased | 98 | 9.0 7.4–11.0ROR 9.2 · χ² 694 / p 3e-153 | 8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Weight increased (weight gain) | 97 | 2.2 1.8–2.7ROR 2.3 · χ² 66 / p 2e-16 | 2.2 EB05 1.9 · IC025 +0.8 | No label text to screen | – | no trial data cached |
| Illness | 94 | 4.8 3.9–5.9ROR 4.9 · χ² 281 / p 2e-63 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Respiratory failure | 94 | 6.6 5.4–8.1ROR 6.8 · χ² 445 / p 5e-99 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Seizure | 85 | 3.8 3.1–4.7ROR 3.9 · χ² 174 / p 4e-40 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Covid-19 | 83 | 2.4 2.0–3.0ROR 2.4 · χ² 68 / p 9e-17 | 2.4 EB05 2.0 · IC025 +0.9 | No label text to screen | – | 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 Laronidase?
In FDA FAERS, the most frequently co-reported reaction terms for Laronidase are pyrexia, pneumonia, cough, influenza, urticaria, nasopharyngitis. 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 Laronidase have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Laronidase 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 158 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.