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Copanlisib Side Effects

For the Consumer

Applies to copanlisib: intravenous powder for solution

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

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • chest pain
  • 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
  • tightness in the chest
  • troubled breathing
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

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

  • 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

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]

References

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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