Imiglucerase side effects: what 4,703 FDA adverse event reports show
Drug class
Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Brand names
Cerezyme
Who reports
4,703 reports · 70% serious · 820 with death outcome · 59% female
Used for
CEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. CEREZYME is a hydrolytic lysosomal glucocerebrosidase-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. ( 1 )
What it is
Imiglucerase is a hydrolytic lysosomal glucocerebrosidase-specific enzyme. It is an analogue of the human enzyme b-glucocerebrosidase (b-D-glucosyl-N-acylsphingosine glucohydrolase, E.C. 3.2.1.45), produced by recombinant DNA technology using mammalian cell culture (Chinese hamster ovary).
Boxed warning
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 137 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 |
|---|---|---|---|---|---|---|
| Poor venous access | 60 | 26.1 20.3–33.5ROR 26.4 · χ² 1,413 / p <1e-300 | 25.7 EB05 20.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial data cached |
| Splenomegaly | 66 | 25.3 19.9–32.1ROR 25.6 · χ² 1,506 / p <1e-300 | 25.0 EB05 20.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 | no trial data cached |
| Status epilepticus | 39 | 15.4 11.3–21.1ROR 15.5 · χ² 510 / p 3e-113 | 15.2 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 29% (drug 59%) | no trial data cached |
| Hepatomegaly | 34 | 15.4 11.0–21.5ROR 15.5 · χ² 442 / p 2e-98 | 15.1 EB05 11.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Bone disorder | 48 | 11.7 8.8–15.5ROR 11.8 · χ² 457 / p 1e-101 | 11.3 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Exposure during pregnancy | 162 | 11.6 10.0–13.5ROR 12.0 · χ² 1,566 / p <1e-300 | 11.5 EB05 10.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · ♀ 99% (drug 59%) | no trial data cached |
| Osteonecrosis (bone death) | 85 | 11.5 9.3–14.2ROR 11.7 · χ² 800 / p 2e-176 | 11.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Bone pain | 147 | 11.2 9.6–13.1ROR 11.5 · χ² 1,356 / p 4e-297 | 11.1 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Epilepsy | 62 | 9.1 7.1–11.6ROR 9.2 · χ² 437 / p 2e-97 | 8.7 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 32 | 9.1 6.4–12.8ROR 9.1 · χ² 221 / p 2e-50 | 8.4 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.9 | no trial data cached |
| Hip arthroplasty | 28 | 8.2 5.7–11.9ROR 8.3 · χ² 171 / p 3e-39 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Convulsion (seizure) | 103 | 7.9 6.6–9.6ROR 8.1 · χ² 617 / p 1e-136 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Abortion spontaneous | 70 | 7.8 6.2–9.8ROR 7.9 · χ² 406 / p 1e-90 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 100% (drug 59%) | no trial data cached |
| Aspiration | 18 | 7.4 4.7–11.8ROR 7.4 · χ² 94 / p 2e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Myoclonus | 19 | 7.1 4.5–11.1ROR 7.1 · χ² 94 / p 2e-22 | 6.2 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Pulmonary hypertension | 32 | 6.8 4.8–9.7ROR 6.9 · χ² 153 / p 2e-35 | 6.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Malnutrition | 17 | 6.8 4.2–11.0ROR 6.9 · χ² 79 / p 3e-19 | 5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Device related infection | 22 | 6.4 4.2–9.7ROR 6.4 · χ² 94 / p 1e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Drug exposure during pregnancy | 48 | 6.2 4.7–8.2ROR 6.3 · χ² 205 / p 1e-46 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 96% (drug 59%) | no trial data cached |
| Pregnancy | 28 | 6.2 4.3–8.9ROR 6.2 · χ² 116 / p 2e-27 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 100% (drug 59%) | no trial data cached |
| Caesarean section | 16 | 6.1 3.7–9.9ROR 6.1 · χ² 63 / p 1e-15 | 5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Respiratory failure | 95 | 5.8 4.8–7.1ROR 5.9 · χ² 374 / p 1e-83 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Femur fracture | 40 | 5.7 4.2–7.8ROR 5.8 · χ² 152 / p 3e-35 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Weight fluctuation | 13 | 5.6 3.2–9.6ROR 5.6 · χ² 44 / p 1e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Pneumonia aspiration | 31 | 5.6 3.9–7.9ROR 5.6 · χ² 111 / p 3e-26 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 32% (drug 59%) · 93% clinician | no trial data cached |
| Infusion site pain | 15 | 5.2 3.2–8.7ROR 5.3 · χ² 47 / p 3e-12 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Osteomyelitis | 21 | 5.2 3.4–7.9ROR 5.2 · χ² 67 / p 2e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Respiratory distress | 32 | 5.2 3.7–7.3ROR 5.2 · χ² 104 / p 1e-24 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 23% (drug 59%) | no trial data cached |
| Lung infection | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 55 / p 5e-14 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Hepatic cirrhosis | 21 | 5.0 3.3–7.7ROR 5.0 · χ² 64 / p 8e-16 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Sudden death | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.1 | no trial data cached |
| Disease progression | 128 | 4.8 4.1–5.7ROR 5.0 · χ² 388 / p 1e-86 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Respiratory disorder | 32 | 4.8 3.4–6.7ROR 4.8 · χ² 91 / p 6e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Respiratory arrest | 28 | 4.5 3.1–6.5ROR 4.5 · χ² 73 / p 8e-18 | 4.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 26% (drug 59%) | no trial data cached |
| Nervous system disorder | 31 | 4.4 3.1–6.3ROR 4.4 · χ² 79 / p 4e-19 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Sars-cov-2 test positive | 13 | 4.3 2.5–7.5ROR 4.4 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious n=7 | no trial data cached |
| Tachypnoea | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Upper limb fracture | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 44 / p 2e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Choking | 18 | 4.1 2.6–6.6ROR 4.1 · χ² 40 / p 1e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Wrist fracture | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 9e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | 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 |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 213 | 2.7 2.4–3.1ROR 2.8 · χ² 238 / p 5e-54 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Fall | 170 | 2.3 2.0–2.6ROR 2.3 · χ² 123 / p 8e-29 | 2.3 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Exposure during pregnancy | 162 | 11.6 10.0–13.5ROR 12.0 · χ² 1,566 / p <1e-300 | 11.5 EB05 10.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · ♀ 99% (drug 59%) | no trial data cached |
| Weight increased (weight gain) | 159 | 3.2 2.7–3.7ROR 3.3 · χ² 238 / p 5e-54 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Bone pain | 147 | 11.2 9.6–13.1ROR 11.5 · χ² 1,356 / p 4e-297 | 11.1 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Disease progression | 128 | 4.8 4.1–5.7ROR 5.0 · χ² 388 / p 1e-86 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Convulsion (seizure) | 103 | 7.9 6.6–9.6ROR 8.1 · χ² 617 / p 1e-136 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Respiratory failure | 95 | 5.8 4.8–7.1ROR 5.9 · χ² 374 / p 1e-83 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Osteonecrosis (bone death) | 85 | 11.5 9.3–14.2ROR 11.7 · χ² 800 / p 2e-176 | 11.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Platelet count decreased | 79 | 3.3 2.7–4.1ROR 3.3 · χ² 125 / p 2e-29 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 2.8 | no trial data cached |
| Nasopharyngitis (common cold) | 77 | 1.9 1.5–2.3ROR 1.9 · χ² 30 / p 2e-8 | 1.8 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Maternal exposure during pregnancy | 76 | 3.8 3.1–4.8ROR 3.9 · χ² 158 / p 2e-36 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · ♀ 100% (drug 59%) | no trial data cached |
| Seizure | 73 | 2.8 2.3–3.6ROR 2.9 · χ² 85 / p 1e-20 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Abortion spontaneous | 70 | 7.8 6.2–9.8ROR 7.9 · χ² 406 / p 1e-90 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 100% (drug 59%) | no trial data cached |
| Thrombocytopenia (low platelets) | 67 | 2.7 2.1–3.4ROR 2.7 · χ² 69 / p 4e-17 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | 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.
- Poor venous access — n=60, PRR 26.1
- Splenomegaly — n=66, PRR 25.3
- Status epilepticus — n=39, PRR 15.4
- Hepatomegaly — n=34, PRR 15.4
- Bone disorder — n=48, PRR 11.7
- Osteonecrosis — n=85, PRR 11.5
- Bone pain — n=147, PRR 11.2
- Epilepsy — n=62, PRR 9.1
- Hip arthroplasty — n=28, PRR 8.2
- Convulsion — n=103, PRR 7.9
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 Imiglucerase?
In FDA FAERS, the most frequently co-reported reaction terms for Imiglucerase are pyrexia, fall, weight increased, bone pain, convulsion, respiratory failure. 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 Imiglucerase have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Do FAERS signals prove that Imiglucerase 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 df60f030-866b-4374-a31f-8ae3f6b45c38, effective 20260827; matched on
openfda.generic_name.exact:"IMIGLUCERASE") - 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, 177 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.