Promacta Side Effects

Generic Name: eltrombopag

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

Side Effects of Promacta - for the Consumer

Promacta

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Promacta:

Back pain; diarrhea; indigestion; menstrual changes; mild flu-like symptoms (eg, fever, headache, tiredness, sore throat, body aches); minor muscle aches or pain; nausea; runny or stuff nose; sneezing; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye or eyelid; chest pain; coughing; coughing up blood; dark urine; frequent, painful, or urgent urination; new or worsening vision problems (eg, cloudy vision); pain, redness, tenderness, or swelling in the legs; severe or persistent nausea, vomiting, or stomach pain; symptoms of heart attack (eg, pain in the chest or jaw; numbness or an arm or leg; sudden, severe vomiting or headache; fainting); symptoms of stroke (eg, confusion, slurred speech, sudden vision changes, one-sided weakness); trouble breathing; unusual bruising or bleeding; unusual burning, itching, numbness, or tingling of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Promacta Side Effects - for the Professional

Promacta

Clinical Trials Experience

In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of Promacta. Other serious adverse reactions included liver test abnormalities and thrombotic/thromboembolic complications [see Warnings and Precautions (5.1, 5.4)].

The data described below reflect Promacta exposure to 446 patients with chronic ITP aged 18 to 85, of whom 65% were female across the ITP clinical development program including 3 placebo-controlled studies. Promacta was administered to 277 patients for at least 6 months and 202 patients for at least 1 year.

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 trials of another drug and may not reflect the rates observed in practice.

Table 2 presents the most common adverse drug reactions (experienced by ≥3% of patients receiving Promacta) from the 3 placebo-controlled studies, with a higher incidence in Promacta versus placebo.

In the 3 controlled clinical studies, alopecia, musculoskeletal pain, blood alkaline phosphatase increased, and dry mouth were the adverse reactions reported in 2% of patients treated with Promacta and in no patients who received placebo.

Among 299 patients with chronic ITP who received Promacta in the single-arm extension study, the adverse reactions occurred in a pattern similar to that seen in the placebo-controlled studies. Table 3 presents the most common treatment-related adverse reactions (experienced by ≥3% of patients receiving Promacta) from the extension study.

In a placebo-controlled trial of eltrombopag in non-ITP thrombocytopenic patients with chronic liver disease (CLD), six eltrombopag-treated patients and one patient in the placebo group developed portal vein thromboses [see Warnings and Precautions (5.4)].

Side Effects by Body System - for Healthcare Professionals

Hematologic

In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag.

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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