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Copiktra Side Effects

Generic name: duvelisib

Medically reviewed by Last updated on Mar 11, 2022.

Note: This document contains side effect information about duvelisib. Some of the dosage forms listed on this page may not apply to the brand name Copiktra.

For the Consumer

Applies to duvelisib: oral capsule


Oral route (Capsule)

Warning: Fatal and Serious Toxicities: Infections, Diarrhea, or Colitis, Cutaneous Reactions, and PneumonitisFatal and/or serious infections occurred in 31% of duvelisib-treated patients. Monitor for signs and symptoms of infection. Withhold duvelisib if infection is suspected. Fatal and/or serious diarrhea or colitis occurred in 18% of duvelisib-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold duvelisib. Fatal and/or serious cutaneous reactions occurred in 5% of duvelisib-treated patients. Withhold duvelisib. Fatal and/or serious pneumonitis occurred in 5% of duvelisib-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold duvelisib.

Side effects requiring immediate medical attention

Along with its needed effects, duvelisib (the active ingredient contained in Copiktra) 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 immediately if any of the following side effects occur while taking duvelisib:

More common

  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • body aches or pain
  • chest pain or tightness
  • chills
  • cough
  • cracked lips
  • decreased urine
  • difficulty in swallowing
  • dry mouth
  • ear congestion
  • fever
  • headache
  • increased thirst
  • irregular heartbeat
  • itching
  • joint or muscle pain
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • runny or stuffy nose
  • seizures
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach cramps or pain
  • swelling
  • swollen glands
  • tenderness
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • watery or bloody diarrhea

Side effects not requiring immediate medical attention

Some side effects of duvelisib 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

For Healthcare Professionals

Applies to duvelisib: oral capsule


Very common (10% or more): Neutropenia (63%), thrombocytopenia (39%), anemia (45%), lymphocytosis (30%), leukopenia (29%), lymphopenia (21%)[Ref]


Very common (10% or more): Infection/sepsis (31%)[Ref]


Very common (10% or more): Musculoskeletal pain (20%), arthralgia (10%)[Ref]


Very common (10% or more): Lipase increased (36%), hypophosphatemia (31%), ALP increased (29%), serum amylase increased (28), hyponatremia (27%), hyperkalemia (J26%), hypoalbuminemia (25%), creatinine increased (24%), hypocalcemia (23%), decreased appetite (14%), edema (14%), hypokalemia (10%)[Ref]


aminotransferase increased, aspartate aminotransferase increased, transaminases increased, hypertransaminasemia, hepatocellular injury, hepatotoxicity) (15%)[Ref]


Very common (10% or more): Cough (25%), dyspnea (12%)

Common (1% to 10%): Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) reactivation/infection[Ref]


Very common (10% or more): Fatigue (29%), pyrexia (26%)[Ref]


The most common adverse reactions (reported in 20% or more of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.[Ref]

Nervous system

Very common (10% or more): Headache (12%)[Ref]


Very common (10% or more): Upper respiratory tract infection (21%), pneumonia (21%), lower respiratory tract infection (10%)[Ref]


Very common (10% or more): Rash (e.g., dermatitis [including allergic, exfoliative, perivascular], erythema [including multiforme], rash [including exfoliative, erythematous, follicular, generalized, macular/papular, pruritic, pustular], toxic epidermal necrolysis, toxic skin eruption, drug reaction with eosinophilia and systemic symptoms, drug eruption, Stevens-Johnson syndrome)

Common (1% to 10%): Cutaneous reactions

Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN)[Ref]


Very common (10% or more): Diarrhea/colitis (includes colitis, enterocolitis, colitis microscopic, colitis ulcerative, diarrhea, diarrhea hemorrhagic) (50%), nausea (24%), abdominal pain (18%), vomiting (16%), mucositis (14%), constipation (13%)[Ref]

Frequently asked questions


1. "Product Information. Copiktra (duvelisib)." Verastem, Inc. (2018):

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.