What the label lists and what reports show
Olipudase alfa side effects
Olipudase alfa's FDA label: “Most common adverse reactions in adult patients (incidence ≥10%) are headache, cough, diarrhea, hypotension, and ocular hyperemia.” FAERS holds 123 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 headache (10 reports).
- No generic listed
- Boxed warning
Check it at the source: the olipudase alfa FDA label on DailyMed (effective December 11, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adult patients (incidence ≥10%) are headache, cough, diarrhea, hypotension, and ocular hyperemia.
Table 8: Adverse Reactions Occurring at ≥13% in XENPOZYME-Treated Pediatric Patients with ASMD in Trial 2 Duration of treatment in Trial 2 was 64 weeks. All patients continued into Trial 3. and Trial 3 for an Overall…
| Adverse Reactions | XENPOZYME N=8 Abdominal pain includes abdominal pain and abdominal pain upper Fatigue includes fatigue and asthenia Rash includes rash and erythema |
|---|---|
| Pyrexia | 8 (100%) |
| Cough | 6 (75%) |
| Diarrhea | 6 (75%) |
| Rhinitis | 6 (75%) |
| Abdominal pain | 5 (63%) |
| Vomiting | 4 (50%) |
| Headache | 4 (50%) |
| Urticaria | 4 (50%) |
| Nausea | 3 (38%) |
| Rash | 3 (38%) |
| Arthralgia | 3 (38%) |
| Pruritus | 2 (25%) |
| Fatigue | 2 (25%) |
| Pharyngitis | 2 (25%) |
| C-reactive protein increased | 1 (13%) |
| Hypotension | 1 (13%) |
| Anaphylactic reaction | 1 (13%) |
| Hypersensitivity | 1 (13%) |
| Infusion site swelling | 1 (13%) |
| Tachycardia | 1 (13%) |
| Pharyngeal swelling | 1 (13%) |
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 following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions (IARs) [see Warnings and Precautions (5.2) ] Elevated Transaminase Levels [see Warnings and Precautions (5.3) ] Most common adverse reactions in adult patients (incidence ≥10%) are headache, cough, diarrhea, hypotension, and ocular hyperemia. ( 6.1 ) Most common adverse reactions in pediatric patients (incidence ≥20%) are pyrexia, cough, diarrhea, rhinitis, abdominal pain, vomiting, headache, urticaria, nausea, rash, arthralgia, pruritus, fatigue, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 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. The pooled safety analysis from 3 clinical trials included a total of 38 XENPOZYME-treated patients (30 adult and 8 pediatric patients) with age range from 1.5 to 59 years old receiving intravenous doses up to 3 mg/kg every 2 weeks [see Clinical Studies (14) ]. …
Source: FDA drug label, Genzyme Corporation, effective December 11, 2025 (SPL set 01a910ee-a33e-4be3-ac41-322d64c34311), via openFDA; the full label on DailyMed
What do FAERS reports show?
123 reports list olipudase alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 18 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 22 reactions below, 11 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.
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?
- Olipudase 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