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What the label lists and what reports show

Imiglucerase side effects

Imiglucerase's FDA label lists its adverse reactions in its own words. FAERS holds 4,703 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (213 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the imiglucerase FDA label on DailyMed (effective August 27, 2026, Genzyme Corporation); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions [see Warnings and Precautions (5.2) ] Adverse reactions reported in adults and pediatric patients include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials and Postmarketing Experience The following adverse reactions associated with the use of imiglucerase were identified in clinical studies or postmarketing reports. …

Source: FDA drug label, Genzyme Corporation, effective August 27, 2026 (SPL set df60f030-866b-4374-a31f-8ae3f6b45c38), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,703 reports list imiglucerase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 820 are coded as a death and 1,460 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Pyrexia (named in the label)213
  • Fatigue (named in the label)186
  • Death (an outcome recorded in the report)174
  • Pneumonia174
  • Fall170
  • Exposure During Pregnancy (a use or a product term, not a reaction)162
  • Weight Increased159
  • Dyspnoea (named in the label)148
  • Bone Pain147
  • Weight Decreased138
  • Malaise136
  • Arthralgia130
  • Disease Progression (a use or a product term, not a reaction)128
  • Pain118
  • Condition Aggravated (a use or a product term, not a reaction)116
  • Dizziness (named in the label)115
  • Cough (named in the label)107
  • Headache (named in the label)105
  • Convulsion103
  • Vomiting (named in the label)102
  • Nausea (named in the label)95
  • Pain In Extremity95
  • Respiratory Failure95
  • Osteonecrosis85
  • Parkinson^S Disease85

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Imiglucerase: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions