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Copanlisib Side Effects

For the Consumer

Applies to copanlisib: intravenous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Feeling very tired or weak.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • Mouth irritation or mouth sores.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at

For Healthcare Professionals

Applies to copanlisib: intravenous powder for injection


The most common (20% or greater) adverse reactions were hyperglycemia, decreased hemoglobin, decreased lymphocyte count, decreased white blood cell count, decreased platelet count, decreased neutrophil count, hypertriglyceridemia, hypophosphatemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, hyperuricemia, thrombocytopenia, lower respiratory tract infections, and increased serum lipase.[Ref]


Very common (10% or more): Hyperglycemia (95%)[Ref]


Very common (10% or more): Decreased hemoglobin (78%), decreased lymphocyte count (78%), decreased white blood cell count (71%), decreased platelet count (65%), decreased neutrophil count (63%), leukopenia (36%), neutropenia/febrile neutropenia (32%), thrombocytopenia (22%)[Ref]


Very common (10% or more): Hypertriglyceridemia (58%), hypophosphatemia (44%), increased serum lipase (21%)[Ref]


Very common (10% or more): Diarrhea (36%), nausea (26%), stomatitis/oral pain/oropharyngeal erosion and ulcer (14%), vomiting (13%)[Ref]


Very common (10% or more): Decreased general strength and energy/fatigue/asthenia (36%)
Common (1% to 10%): Mucosal inflammation[Ref]


Very common (10% or more): Hyperuricemia (25%)[Ref]


Very common (10% or more): Lower respiratory tract infections (21%)
Common (1% to 10%): Pneumonitis[Ref]

Nervous system

Common (1% to 10%): Paresthesia, dysesthesia[Ref]


Very common (10% or more): Rash/exfoliative skin reactions (15%)[Ref]


Very common (10% or more): Hypertension/secondary hypertension (13%)[Ref]


1. "Product Information. Aliqopa (copanlisib)." Bayer Pharmaceutical Inc, West Haven, CT.

Some side effects of copanlisib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.