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Fabrazyme Side Effects

Generic Name: agalsidase beta

Note: This page contains information about the side effects of agalsidase beta. Some of the dosage forms included on this document may not apply to the brand name Fabrazyme.

For the Consumer

Applies to agalsidase beta: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by agalsidase beta (the active ingredient contained in Fabrazyme). In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking agalsidase beta:

More common:
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • cough producing mucus
  • difficulty breathing
  • difficulty in moving
  • dizziness;
  • fatigue
  • faintness or lightheadedness when getting up from a lying or sitting position suddenly
  • feeling unusually cold shivering
  • headache
  • hives or welts
  • irregular heartbeat
  • itching
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • nervousness
  • pain
  • pounding in the ears
  • redness of skin
  • shortness of breath
  • skin rash
  • stomach pain
  • sweating
  • swelling of ankles, feet, and lower legs
  • swollen joints
  • tightness in chest
  • unusual tiredness or weakness
  • wheezing
Incidence unknown
  • Cloudy or bloody urine
  • decreased cardiac output
  • difficulty in speaking
  • double vision
  • feeling of constant movement of self or surroundings
  • high blood pressure
  • inability to move arms, legs, or facial muscles
  • inability to speak
  • no blood pressure or pulse
  • partial loss of hearing
  • pounding or rapid pulse
  • problems with muscle control or coordination
  • sensation of spinning
  • shakiness and unsteady walk
  • slow speech
  • stopping of heart
  • swelling of face
  • swelling of the lip or ear
  • throat tightness
  • trembling
  • unconsciousness

Severity: Minor

Some of the side effects that can occur with agalsidase beta may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acid or sour stomach
  • belching
  • body aches or pain
  • body produces substance that can bind to drug making it less effective or cause side effects
  • burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
  • congestion
  • discouragement
  • dryness or soreness of throat
  • fear
  • feeling sad or empty
  • fever, not related to infusion
  • heartburn
  • hoarseness
  • indigestion
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • nausea
  • pain or tenderness around eyes and cheekbones
  • paleness of skin
  • runny nose
  • sensation of change in temperature
  • skeletal pain
  • sneezing
  • stuffy nose; swelling of testes
  • tender, swollen glands in neck
  • trouble concentrating
  • trouble sleeping
  • trouble in swallowing
  • voice changes

For Healthcare Professionals

Applies to agalsidase beta: intravenous powder for injection


In general, infusion-related side effects have been reported the most frequently. These have included tachycardia, hypertension, urticaria, chest pain, fever, and rigors. Temperature changed sensation and pallor have also been reported.[Ref]


Cardiovascular side effects have included hypertension (greater than 10%), reports of cardiomegaly, hypotension, and edema.[Ref]

Nervous system

Nervous system side effects including pain related to Fabry disease and headache have been reported in greater than 10% of patients. Cerebrovascular events (i.e., symptomatic stroke or transient ischemic attack) were reported in 9% of patients. Dizziness and paraesthesia have also been reported.[Ref]


Gastrointestinal side effects have included reports of dyspepsia and nausea.[Ref]


Musculoskeletal side effects have included reports of arthrosis and skeletal pain.[Ref]


Psychiatric side effects have included reports of anxiety and depression.[Ref]


Respiratory side effects have included reports of bronchitis, bronchospasm, laryngitis, pharyngitis, rhinitis, and sinusitis.[Ref]


Genitourinary side effects reported by men involved in the placebo controlled study have included testicular pain.[Ref]


Immunologic side effects have included reports of the development of antibodies to agalsidase beta (the active ingredient contained in Fabrazyme) Most patients involved in clinical studies developed antibodies within the first 3 months of exposure.[Ref]

The reported rates of IgG seroconversion during the clinical studies were 88% and 89%. There are reports of decrease in titers after 12 months of treatment and one case that became seronegative. Seroconversion did not affect the efficacy end points. The clinical significance of the antibodies to agalsidase beta is not yet known.[Ref]


Other side effects including chills have been reported in greater than 10% of patients.[Ref]


1. Keating GM, Simpson D "Agalsidase Beta : a review of its use in the management of fabry disease." Drugs 67 (2007): 435-55

2. "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation, Cambridge, MA.

3. Mougenot P, Lidove O, Caillaud C, Arnaud P, Papo T "Fabry disease and treatment with agalsidase alpha: unsuspected cardiac arrhythmia in two heterozygous women. In reference to pharmacovigilance." Eur J Clin Pharmacol 64 (2008): 635-9

4. Eng CM, Guffon n, Wilcox WR, et al "Safety and efficacy of recombinant human alpha-galactosidase A--replacement therapy in Fabry's disease." N Engl J Med 345 (2001): 9-16

Not all side effects for Fabrazyme may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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