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Umbralisib Side Effects

The most commonly reported side effects of umbralisib include diarrhoea, nausea, and fatigue, based on 305 FDA adverse event reports from 2017 to 2025. 4.3% of reports found the drug to be ineffective.

Umbralisib side effects

Percentages show how often each reaction appears relative to total reports for umbralisib.

1
Diarrhoea15.7%48
2
Nausea12.1%37
3
Fatigue10.2%31
4
Disease Progression9.5%29
5
Covid-195.6%17
6
Death5.2%16
7
Nervous System Disorder4.9%15
8
Drug Ineffective4.3%13
9
Off Label Use4.3%13
10
Asthenia4.3%13
11
Headache3.9%12
12
Product Dose Omission Issue3.9%12
13
Decreased Appetite3.6%11
14
Vomiting3.6%11
15
Anaemia3.6%11

These are voluntary reports and do not establish that umbralisib caused these reactions.

Report severity

52.1%Serious159 reports
32.1%Hospitalizations98 reports
10.5%Fatal32 reports

Seriousness is determined by the reporter, not by OpenClaim.

Umbralisib drug interactions

Other drugs that appear in adverse event reports alongside umbralisib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ublituximab-xiiy26.9%82
2
Venetoclax8.2%25
3
Doxorubicin-hydrochloride7.9%24
4
Rituximab7.9%24
5
Vincristine-sulfate7.2%22
6
Cyclophosphamide7.2%22
7
Ibrutinib6.9%21
8
Lenalidomide6.9%21
9
Prednisone6.2%19
10
Dexamethasone5.2%16
11
Cytarabine4.9%15
12
Polatuzumab-vedotin-piiq4.9%15
13
Cisplatin4.9%15
14
Bendamustine-hydrochloride3.9%12
15
Prednisolone3.3%10

Taken alongside

1
Acyclovir17.0%52
2
Sulfamethoxazole12.5%38
3
Trimethoprim12.5%38
4
Atorvastatin-calcium9.2%28
5
Acetaminophen8.9%27
6
Allopurinol8.5%26
7
Aspirin8.2%25
8
Levothyroxine-sodium7.9%24
9
Ondansetron7.5%23
10
Ergocalciferol6.6%20
11
Amlodipine6.6%20
12
Metoprolol5.2%16
13
Fluticasone5.2%16
14
Dapsone4.9%15
15
Ascorbic-acid4.9%15

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports umbralisib side effects

36.7% of umbralisib adverse event reports involve female patients and 49.5% involve male patients. The largest age group is elderly at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.7%
Male49.5%
Unknown13.8%

Age group

< 20.0%
2–110.0%
12–170.5%
18–6437.6%
65+61.9%

What is umbralisib used for

Conditions and purposes for which patients were taking umbralisib when the adverse event was reported.

B-cell LymphomaB-cell Lymphoma Stage IiB-cell Small Lymphocytic LymphomaChronic Lymphocytic LeukaemiaChronic Lymphocytic Leukaemia (in Remission)Carcinoid TumourChronic Lymphocytic LeukaemiaChronic Lymphocytic Leukaemia RefractoryDiffuse Large B-cell LymphomaDiffuse Large B-cell LymphomaExtranodal Marginal Zone B-cell Lymphoma (malt Type)Follicular LymphomaFollicular LymphomaFollicular Lymphoma Stage IFollicular Lymphoma Stage Ii

Showing 15 of 40 indications

Umbralisib brand names and reporting trend

Umbralisib is sold under the brand name Ukoniq.

Brand names

Ukoniq316

Quarterly reports (20172025)

2017202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking umbralisib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.