Copanlisib Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 17, 2025.

Applies to copanlisib: intravenous powder for solution.

Serious side effects of copanlisib

Along with its needed effects, copanlisib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking copanlisib:

More common side effects

• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain or tightness
• chills
• cough
• cracks in the skin
• dizziness
• dry mouth
• fatigue
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• loss of heat from the body
• lower back or side pain
• nausea
• nervousness
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• red, swollen skin
• scaly skin
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• sweating
• swollen glands
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Other side effects of copanlisib

Some side effects of copanlisib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cracked lips
• diarrhea
• difficulty in swallowing
• lack or loss of strength
• swelling or inflammation of the mouth

For healthcare professionals

Applies to copanlisib: intravenous powder for injection.

General adverse events

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]

Endocrine

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

Hematologic

• 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]

Metabolic

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

Gastrointestinal

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

Other

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

Genitourinary

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

Respiratory

• 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]

Dermatologic

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

Cardiovascular

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

Further information

Copanlisib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer