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Elelyso Side Effects

Generic Name: taliglucerase alfa

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

In Summary

Common side effects of Elelyso include: headache, arthralgia, and back pain. Other side effects include: weakness, chest pain, fatigue, increased blood pressure, urticaria, chest discomfort, erythema, and flushing. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to taliglucerase alfa: intravenous powder for solution

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

If any of the following side effects occur while taking taliglucerase alfa, check with your doctor or nurse immediately:

More common:
  • Chest tightness
  • dizziness
  • feeling of warmth
  • hives or welts, itching, or skin rash
  • irritation in the throat
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea or vomiting
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
Less common:
  • Blurred vision
  • confusion
  • cough
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • sweating
  • unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with taliglucerase alfa 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:
  • Abdominal or stomach pain
  • difficulty with moving
  • feeling of warmth
  • headache
  • muscle pain or stiffness
  • pain in the joints
Incidence not known:
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to taliglucerase alfa: intravenous powder for injection


The most frequently reported side effects were headache, arthralgia, pain in extremity, fatigue, nausea, dizziness, pruritus, flushing, abdominal pain, vomiting, back pain, and rash.[Ref]


Very common (10% or more): Vomiting, abdominal pain
Common (1% to 10%): Nausea, diarrhea
Frequency not reported: Gastrointestinal inflammation[Ref]


In clinical trials, hypersensitivity reactions (including anaphylaxis) were reported in 29% of patients; these reactions occurred up to 3 hours after the start of infusion. Serious hypersensitivity reactions (including anaphylaxis) were reported in some patients. In clinical trials, 3% of patients had signs/symptoms consistent with anaphylaxis; these reactions occurred during the infusion.[Ref]

Very common (10% or more): Hypersensitivity reactions (including anaphylaxis; 29%)
Frequency not reported: Type III immune-mediated fixed drug eruption
Postmarketing reports: Anaphylaxis[Ref]


Very common (10% or more): Arthralgia (up to 13%), pain in extremity (up to 10%)
Common (1% to 10%): Back pain, bone pain
Frequency not reported: Muscle spasms[Ref]


Very common (10% or more): Development of anti-drug antibodies (up to 53%), neutralizing antibodies detected (10.3%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Dizziness, paresthesia
Frequency not reported: Tremor[Ref]


Common (1% to 10%): Fatigue, flushing, peripheral edema, infusion reaction, weight increased
Frequency not reported: Chest discomfort, feeling hot[Ref]

Infusion-related reactions occurred most often within 24 hours of the infusion and consisted of arthralgia, headache, vomiting, flushing, pruritus, pain in extremity, pulmonary hypertension, diarrhea, chest discomfort, feeling hot, muscle spasms, tremor, throat irritation, erythema, and rash.[Ref]


Common (1% to 10%): Pruritus, erythema, rash, urticaria[Ref]


Common (1% to 10%): Throat irritation, rhinorrhea, sneezing
Frequency not reported: Pulmonary hypertension[Ref]


Common (1%to 10%): ALT increased[Ref]


Common (1% to 10%): Infusion site pain[Ref]


Common (1% to 10%): Eye pruritus, eye swelling, lacrimation increased[Ref]


1. "Product Information. Elelyso (taliglucerase alfa)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

2. Cerner Multum, Inc. "Australian Product Information." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.