OpenClaim

Leniolisib Side Effects

The most commonly reported side effects of leniolisib include infection, product dose omission issue, and off label use, based on 655 FDA adverse event reports from 2019 to 2025.

Leniolisib side effects

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

1
Infection15.9%104
2
Product Dose Omission Issue13.7%90
3
Off Label Use8.4%55
4
Sinusitis5.6%37
5
Headache4.6%30
6
Nasopharyngitis4.6%30
7
Fatigue3.2%21
8
Nausea3.2%21
9
Ear Infection3.2%21
10
Alopecia3.1%20
11
Pneumonia2.9%19
12
Drug Interaction2.4%16
13
Vomiting2.4%16
14
Diarrhoea2.4%16
15
Covid-192.1%14

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

Report severity

20.2%Serious132 reports
9.6%Hospitalizations63 reports
0.9%Fatal6 reports

Seriousness is determined by the reporter, not by OpenClaim.

Leniolisib drug interactions

Other drugs that appear in adverse event reports alongside leniolisib. 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
Itraconazole0.6%4
2
Rituximab0.5%3
3
Letermovir0.2%1
4
Ibuprofen0.2%1
5
Amlodipine0.2%1
6
Lamotrigine0.2%1
7
Prednisone0.2%1
8
Carbamazepine0.2%1
9
Methotrexate0.2%1
10
Sulfasalazine0.2%1
11
Valsartan0.2%1
12
Atorvastatin-calcium0.2%1
13
Cannabidiol0.2%1

Taken alongside

1
Albuterol38.9%255
2
Fluticasone24.0%157
3
Cetirizine-hydrochloride23.4%153
4
Acetaminophen19.5%128
5
Epinephrine17.1%112
6
Sodium-chloride15.4%101
7
Mometasone-furoate13.9%91
8
Ergocalciferol13.6%89
9
Omeprazole12.5%82
10
Ondansetron12.5%82
11
Sulfamethoxazole12.2%80
12
Trimethoprim12.1%79
13
Budesonide11.8%77
14
Sirolimus11.6%76
15
Ibuprofen11.5%75

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 leniolisib side effects

0.3% of leniolisib adverse event reports involve female patients and 1.1% involve male patients. The largest age group is adult at 78%. These figures reflect who reports side effects, not underlying risk.

Sex

Female0.3%
Male1.1%
Unknown98.6%

Age group

< 20.0%
2–1111.1%
12–1711.1%
18–6477.8%
65+0.0%

What is leniolisib used for

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

Activated Pi3 Kinase Delta SyndromeAutoimmune Lymphoproliferative SyndromeColitisEncephalitisHenoch-schonlein PurpuraIga NephropathyImmunodeficiency Common VariableImmunomodulatory TherapyInfectionLiver DisorderLymphoproliferative DisorderProduct Used For Unknown IndicationProduct Used For Unknown Indication

Leniolisib brand names and reporting trend

Leniolisib is sold under the brand name Joenja.

Brand names

Joenja72

Quarterly reports (20192025)

2019202220242025

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

Taking leniolisib with another medication?

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