What the label lists and what reports show
Taliglucerase alfa side effects
Taliglucerase alfa's FDA label: “The most common adverse reactions are: • Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria ( 6.1 ).” FAERS holds 566 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 fatigue (71 reports).
- No generic listed
- Boxed warning
Check it at the source: the taliglucerase alfa FDA label on DailyMed (effective December 29, 2025, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions are: • Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria ( 6.1 ).
Table 1: Adverse Reactions in ≥5% of Treatment-Naïve Adult Patients Treated with ELELYSO
| Preferred Term | Treatment-Naïve Adults (N=32) n (%) |
|---|---|
| Headache | 6 (19) |
| Arthralgia | 4 (13) |
| Fatigue | 3 (9) |
| Nausea | 3 (9) |
| Dizziness | 3 (9) |
| Abdominal pain | 2 (6) |
| Pruritus | 2 (6) |
| Flushing | 2 (6) |
| Vomiting | 2 (6) |
| Urticaria | 2 (6) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions are: • Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria ( 6.1 ). • Patients who Switched from Imiglucerase, after 9 Months on Treatment (≥10%): arthralgia, headache, pain in extremity ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials of ELELYSO as Initial Therapy • Clinical Trial in Adult Patients The safety of ELELYSO at dosages of either 30 units/kg (n=16) (50% of the recommended dosage) [see Dosage and Administration (2.1) ] or 60 units/kg (n=16) administered intravenously every other week was assessed in 32 adult treatment-naïve patients (aged 19 to 74 years) with Type 1 Gaucher disease in a 9-month double-blind, randomized clinical trial (Trial 1) [see Clinical Studies (14) ]. Table 1 presents the adverse reactions that occurred in these ELELYSO-treated patients.
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective December 29, 2025 (SPL set fa3cbd5d-677c-4b19-9032-d9182cb69a83), via openFDA; the full label on DailyMed
What do FAERS reports show?
566 reports list taliglucerase alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 114 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 20 reactions below, 9 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Taliglucerase alfa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions