What the label lists and what reports show
Pegunigalsidase alfa side effects
Pegunigalsidase alfa's FDA label: “Most common adverse reactions (≥15%) are: infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.” FAERS holds 354 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 (37 reports).
- No generic listed
- Boxed warning
Check it at the source: the pegunigalsidase alfa FDA label on DailyMed (effective July 8, 2024); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥15%) are: infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
Table 3: Adverse Reactions in Adults With Fabry Disease (Trial 2) 1
| Adverse Reaction | ELFABRIO N=52 n (%) | Agalsidase beta N=25 n (%) |
|---|---|---|
| Infusion-Associated Reaction 2,4 | 17 (32) | 8 (32) |
| Nasopharyngitis | 11 (21) | 4 (16) |
| Headache | 11 (21) | 5 (20) |
| Diarrhea | 10 (19) | 6 (24) |
| Fatigue | 9 (17) | 4 (16) |
| Nausea | 9 (17) | 3 (12) |
| Back pain | 8 (15) | 5 (20) |
| Pain in Extremity | 8 (15) | 4 (16) |
| Sinusitis | 8 (15) | 3 (12) |
| Abdominal Pain | 6 (12) | 0 (0) |
| Proteinuria | 6 (12) | 0 (0) |
| Hypersensitivity 3,4 | 5 (9) | 4 (16) |
| Upper Respiratory Tract Congestion | 4 (8) | 0 (0) |
| Neuralgia | 4 (8) | 0 (0) |
| Peripheral Neuropathy | 3 (6) | 0 (0) |
| Sciatica | 3 (6) | 0 (0) |
| Infusion Site Extravasation | 3 (6) | 0 (0) |
| Hematuria | 3 (6) | 0 (0) |
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 labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 ) ] Infusion-Associated Reactions (IARs) [see Warnings and Precautions ( 5.2 )] Membranoproliferative Glomerulonephritis [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (≥15%) are: infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 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 trial of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions From Trial 2 The safety of ELFABRIO in adults with confirmed Fabry disease who had been previously treated with agalsidase beta was evaluated in Trial 2 which included a total of 52 ELFABRIO-treated patients (29 male, 23 female aged 20 to 60 years old) with Fabry disease [see Clinical Studies ( 14 )]. Patients received 1 mg/kg of ELFABRIO given intravenously every 2 weeks for at least 104 weeks.
Source: FDA drug label, Chiesi USA, Inc., effective July 8, 2024 (SPL set 6fb674bf-744e-431f-92ef-b2a5a66c8cf3), via openFDA; the full label on DailyMed
What do FAERS reports show?
354 reports list pegunigalsidase alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 65 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, 13 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?
- Pegunigalsidase 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