Gavreto Side Effects

Generic name: pralsetinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 1, 2025.

Note: This document provides detailed information about Gavreto.

Applies to pralsetinib: oral capsule Side Effects associated with pralsetinib. Some dosage forms listed on this page may not apply specifically to the brand name Gavreto.

Applies to pralsetinib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 2 weeks after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Check with your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat occurs during or after treatment with this medicine. These can be symptoms of hypertension (high blood pressure).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine can cause serious bleeding problems that may be life-threatening. Check with your doctor right away if you have coughing up blood, increased menstrual flow or vaginal bleeding, nosebleeds, red or black, tarry stools, red or dark brown urine, vomiting of blood or material that looks like coffee grounds, or any unusual bleeding or bruising.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you medicine to help prevent this. Call your doctor right away if you have a decrease or change in the amount of urine, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before and after having surgery.

Talk with your doctor before using this medicine if you plan to have children. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Gavreto

Along with its needed effects, pralsetinib (the active ingredient contained in Gavreto) 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 pralsetinib:

Other side effects of Gavreto

Some side effects of pralsetinib 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:

For healthcare professionals

Applies to pralsetinib: oral capsule.

General adverse events

The most common adverse reactions (25% or greater) were fatigue, constipation, diarrhea, musculoskeletal pain, anemia, and hypertension. The most common Grade 3 or 4 laboratory abnormalities (2% or greater) were decreased lymphocytes, decreased neutrophils, decreased phosphate, decreased hemoglobin, decreased sodium, increased aspartate aminotransferase (AST), decreased platelets, increased alkaline phosphatase, decreased calcium (corrected), and increased alanine aminotransferase (ALT). The most common serious adverse reactions were pneumonia, pneumonitis, and anemia.^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 27%, includes cough, productive cough, upper-airway cough syndrome), dyspnea (22%), pneumonia (17%, includes pneumonia, atypical pneumonia, lung infection, pneumocystis Jirovecii pneumonia, bacterial pneumonia, cytomegaloviral pneumonia, haemophilus pneumonia, pneumonia influenza, streptococcal pneumonia)
• Common (1% to 10%): Cough (Grade 3 or 4), pneumonia (Grade 3 or 4)
• Uncommon (0.1% to 1%): Tuberculosis
• Frequency not reported: Interstitial lung disease, pneumonitis^[Ref]

Tuberculosis mostly extrapulmonary, such as lymph node tuberculosis, peritoneal tuberculosis, or renal tuberculosis have been reported.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension all Grades (up to 40%), hypertension Grade 3 or 4 (up to 21%), Hemorrhage (19%)^[Ref]

Hepatic

• Very common (10% or more): Increased AST (69%), increased ALT (46%), increased bilirubin (24%)
• Frequency not reported: Hepatotoxicity^[Ref]

Hematologic

• Very common (10% or more): Decreased neutrophils (61%), decreased lymphocytes (56%), decreased platelets (27%), decreased hemoglobin (58%), grade 3 or 4 decreased neutrophils (16%), grade 3 or 4 decreased lymphocytes (19%), decreased albumin (up to 36%), increased potassium (up to 26%), thrombocytopenia (up to 19%)
• Common (1% to 10%): Decreased hemoglobin (Grade 3 or 4), decreased platelets (Grade 3 or 4), hemorrhage^[Ref]

Oncologic

• Frequency not reported: Tumor lysis syndrome^[Ref]

Clinically relevant tumor lysis syndrome occurred in less than 15% of patients.^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (up to 41%), diarrhea (up to 34%), dry mouth (16%), abdominal pain (includes abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, epigastric discomfort) (17%), stomatitis (includes mucosal inflammation, stomatitis, tongue ulceration) (up to 17%), nausea (17%), vomiting (12%)
• Common (1% to 10%): Diarrhea, colitis, enteritis (Grade 2 or 4), constipation (Grade 3 or 4)^[Ref]

Other

• Very common (10% or more): Fatigue/asthenia (up to 38%), pyrexia (up to 25%) edema (up to 29%, includes edema peripheral, face edema, periorbital edema, eyelid edema, edema generalized, swelling)
• Common (1% to 10%): Fatigue/asthenia (Grade 3 or 4)
• Frequency not reported: Impaired wound healing, embryo-fetal toxicity^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (includes back pain, myalgia, arthralgia, pain in extremity, musculoskeletal pain, neck pain, non-cardiac chest pain, musculoskeletal chest pain, bone pain, musculoskeletal stiffness, arthritis, pain in extremity, spinal pain) (up to 42%)
• Frequency not reported: Increased creatine phosphokinase^[Ref]

Clinically relevant increases in creatine phosphokinase occurred in less than 15% of patients.^[Ref]

Metabolic

• Very common (10% or more): Increased alkaline phosphatase (40%), decreased calcium (corrected) (29%), decreased sodium (27%), decreased phosphate (27%), increased phosphate (10%), decreased appetite (15%)^[Ref]

Renal

• Very common (10% or more): Increased creatinine (42%)^[Ref]

Nervous system

• Common (1% to 10%): Headache (24%) (includes migraine, tension headache), dizziness (19%) (includes dizziness, dizziness postural, vertigo), peripheral neuropathy (up to 20%, includes dysesthesia, hyperesthesia, hypoesthesia, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy), dysgeusia/ageusia (17%), taste disorder (16%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (13%) (includes dermatitis, dermatitis acneiform, eczema, palmar-plantar, erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular)^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

See also:

Further information

Gavreto 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.

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