Promacta Side Effects

Generic name: eltrombopag

Note: This document contains side effect information about eltrombopag. Some of the dosage forms listed on this page may not apply to the brand name Promacta.

Some side effects of Promacta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to eltrombopag: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking eltrombopag (the active ingredient contained in Promacta) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using eltrombopag and call your doctor at once if you have:

• pain or burning when you urinate;

• fever, chills, body aches, flu symptoms, unusual weakness or tired feeling;

• nausea, upper stomach pain, itching, loss of appetite;

• dark urine, clay-colored stools;

• jaundice (yellowing of the skin or eyes);

• pain, swelling, warmth, or redness in one or both legs;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

• blurred vision, eye pain, or seeing halos around lights.

Common side effects may include:

• diarrhea, vomiting, upset stomach;

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• headache, muscle pain, back pain, swelling in your hands or feet;

• tingly feeling;

• mild itching or rash;

• sleep problems (insomnia); or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to eltrombopag: oral tablet

Hematologic

In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag (the active ingredient contained in Promacta)

Hematologic side effects have included hemorrhage and thrombocytopenia (2%).

Gastrointestinal

Gastrointestinal side effects have included nausea (6%), vomiting (4%), and dyspepsia (2%).

Other

Other side effects have included menorrhagia (4%), paresthesia (3%), and ecchymosis (2%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (3%).

Ocular

Ocular side effects have included cataracts (3%) and conjunctival hemorrhage (2%).

Hepatic

Hepatic side effects have included increased ALT (2%) and increased AST (2%).

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