OpenClaim

Copanlisib Side Effects

The most commonly reported side effects of copanlisib include pyrexia, off label use, and hyperglycaemia, based on 390 FDA adverse event reports from 2007 to 2025. 3.8% of reports found the drug to be ineffective.

Copanlisib side effects

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

1
Pyrexia15.9%62
2
Off Label Use12.3%48
3
Hyperglycaemia6.9%27
4
Hypertension6.2%24
5
Rash Maculo-papular6.2%24
6
Neutropenic Sepsis5.6%22
7
Cytopenia5.4%21
8
Pneumonia5.4%21
9
Diarrhoea5.1%20
10
Sepsis4.9%19
11
End Stage Renal Disease4.6%18
12
Tubulointerstitial Nephritis4.6%18
13
Disease Progression4.6%18
14
Rash4.4%17
15
Cytokine Release Syndrome4.1%16

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

Report severity

87.4%Serious341 reports
57.9%Hospitalizations226 reports
12.3%Fatal48 reports

Seriousness is determined by the reporter, not by OpenClaim.

Copanlisib drug interactions

Other drugs that appear in adverse event reports alongside copanlisib. 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
Rituximab42.1%164
2
Bendamustine-hydrochloride25.9%101
3
Obinutuzumab11.0%43
4
Gemcitabine9.2%36
5
Vincristine-sulfate7.9%31
6
Prednisone7.9%31
7
Doxorubicin-hydrochloride7.7%30
8
Cyclophosphamide6.4%25
9
Dexamethasone5.9%23
10
Carboplatin5.4%21
11
Cytarabine5.4%21
12
Vancomycin5.4%21
13
Nivolumab5.4%21
14
Carmustine5.1%20
15
Melphalan5.1%20

Taken alongside

1
Acyclovir11.0%43
2
Trimethoprim8.5%33
3
Sulfamethoxazole8.2%32
4
Allopurinol7.9%31
5
Dexamethasone6.9%27
6
Amlodipine6.7%26
7
Pantoprazole-sodium6.7%26
8
Acetaminophen5.6%22
9
Ondansetron5.6%22
10
Folic-acid5.1%20
11
Prednisone4.9%19
12
Cholecalciferol4.6%18
13
Omeprazole4.4%17
14
Aspirin4.4%17
15
Furosemide4.1%16

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 copanlisib side effects

36.9% of copanlisib adverse event reports involve female patients and 44.1% involve male patients. The largest age group is elderly at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.9%
Male44.1%
Unknown19.0%

Age group

< 20.4%
2–110.4%
12–170.7%
18–6447.6%
65+50.9%

What is copanlisib used for

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

Adenocarcinoma Of ColonAdenoid Cystic Carcinoma Of Salivary GlandAnxietyB-cell LymphomaB-cell Lymphoma RecurrentB-cell Lymphoma RefractoryB-cell LymphomaB-cell Lymphoma RecurrentB-cell Lymphoma RefractoryBrain NeoplasmBreast CancerBreast Cancer MetastaticBurkitt^s Lymphoma RecurrentBreast CancerBreast Cancer Metastatic

Showing 15 of 107 indications

Copanlisib brand names and reporting trend

Copanlisib is sold under the brand name Aliqopa.

Brand names

Aliqopa681

Quarterly reports (20072025)

200720202025

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

Taking copanlisib with another medication?

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