What the label lists and what reports show
Agalsidase beta side effects
Agalsidase beta's FDA label: “Most common adverse reactions (≥20%) are: upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash.” FAERS holds 9,189 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 (523 reports).
- No generic listed
- Boxed warning
Check it at the source: the agalsidase beta FDA label on DailyMed (effective August 22, 2025, Genzyme Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥20%) are: upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash.
Table 2: Summary of Common Adverse Reactions Reported at rate of at least 5% in FABRAZYME-treated patients and greater than 2.5% compared to placebo-treated patients. in Clinical Trials (Study 1 and 2) of Patients with…
| Adverse Reaction | FABRAZYME (n=80) % | Placebo (n=60) % |
|---|---|---|
| Upper respiratory tract infection Includes reports of upper respiratory infection, nasal… | 53 | 42 |
| Chills Includes reports of chills and feeling cold. | 49 | 13 |
| Pyrexia | 39 | 22 |
| Headache | 39 | 28 |
| Cough | 33 | 25 |
| Paresthesia | 31 | 18 |
| Fatigue | 24 | 17 |
| Peripheral edema | 21 | 7 |
| Dizziness | 21 | 8 |
| Rash | 20 | 10 |
| Pain in extremity | 19 | 8 |
| Myalgia Includes reports of myalgia and muscle spasms. | 18 | 7 |
| Lower respiratory tract infection | 18 | 7 |
| Pain | 16 | 13 |
| Back pain | 16 | 10 |
| Hypertension | 14 | 5 |
| Pruritus | 10 | 3 |
| Tachycardia | 9 | 3 |
| Excoriation | 9 | 2 |
| Increased blood creatinine | 9 | 5 |
| Tinnitus | 8 | 3 |
| Dyspnea | 8 | 2 |
| Fall | 6 | 3 |
| Burning sensation | 6 | 0 |
| Anxiety | 6 | 3 |
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 [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥20%) are: upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash. ( 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 Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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 patients in clinical practice. The data described below reflect exposure of 80 patients, ages 16 to 61 years, to 1 mg/kg FABRAZYME every two weeks in two separate double-blind, placebo-controlled clinical trials, for periods ranging from 1 to 35 months (mean 15.5 months). All 58 patients enrolled in one of the two studies continued into an open-label extension study of FABRAZYME treatment for up to 54 additional months. Patients were treated with antipyretics and antihistamines prior to the infusions. …
Source: FDA drug label, Genzyme Corporation, effective August 22, 2025 (SPL set 988513ab-b06f-4dd0-93f7-d2d4531dcce4), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,189 reports list agalsidase beta among the medicines taken, each a report of something that happened, not proof the medicine caused it; 699 are coded as a death and 2,485 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 24 reactions below, 15 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?
- Agalsidase beta: 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