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Ukoniq Side Effects

Generic name: umbralisib

Medically reviewed by Drugs.com. Last updated on Oct 28, 2022.

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

Applies to umbralisib: oral tablets.

Warning

Special Alerts:

MEDWATCH ALERT

FDA Drug Safety Communication Posted February 3, 2022

The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death with the cancer medicine Ukoniq® (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. FDA determined that initial findings from a clinical trial evaluating Ukoniq® to treat a related type of cancer found a possible increased risk of death in patients taking the medicine. Because of the seriousness of this safety concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial, FDA is alerting patients and health care professionals that they are re-evaluating this risk against the benefits of Ukoniq® for its approved uses.

FDA is continuing to evaluate the results from the clinical trial called UNITY. FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq®. FDA has also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq® while we continue to review the UNITY findings. FDA will communicate their final conclusions and recommendations when they have completed their review or have more information to share.

Health care professionals should review patients’ progress on Ukoniq® and discuss with them the risks and benefits of continuing Ukoniq® in the context of other available treatments.

Patients should talk to your health care professionals about the risks and benefits of Ukoniq® or any concerns you may have, including about possible alternative treatments.

Side effects include:

Adverse effects and laboratory abnormalities occurring in ≥15% of umbralisib-treated patients include increased Scr, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, rash.

For Healthcare Professionals

Applies to umbralisib: oral tablet.

Hematologic

Very common (10% or more): Decreased neutrophil decreased (33%), decreased hemoglobin (27%), decrease platelets (26%)

Common (1% to 10%): Transaminase elevation, neutropenia

Frequency not reported: Anemia, thrombocytopenia[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (27%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (19%), decreased potassium (21%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (14%)[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hepatic

Very common (10% or more): Increased alanine aminotransferase (33%), increased aspartate aminotransferase (32%)[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (21%)

Common (1% to 10%): Pneumonia, dyspnea

Rare (less than 0.1%): Pneumonitis[Ref]

General

Very common (10% or more): Pyrexia (10%)

Common (1% to 10%): Sepsis[Ref]

Nervous system

Very common (10% or more): Fatigue (41%)[Ref]

Renal

Very common (10% or more): Increased creatinine (79%)[Ref]

Cardiovascular

Very common (10% or more): Edema (14%)[Ref]

Dermatologic

Very common (10% or more): Rash (18%)

Rare (less than 0.1%): Exfoliative dermatitis[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (58%), nausea (38%), vomiting (21%), abdominal pain (19%)

Common (1% to 10%): diarrhea, colitis[Ref]

References

1. "Product Information. Ukoniq (umbralisib)." TG Therapeutics (2021):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.