Rydapt Side Effects

Generic name: midostaurin

Medically reviewed by Drugs.com. Last updated on Jan 11, 2025.

Note: This document provides detailed information about Rydapt Side Effects associated with midostaurin. Some dosage forms listed on this page may not apply specifically to the brand name Rydapt.

Applies to midostaurin: oral capsule liquid filled.

Serious side effects of Rydapt

Along with its needed effects, midostaurin (the active ingredient contained in Rydapt) 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 midostaurin:

More common side effects

• black, tarry stools
• bloody urine
• body aches or pain
• bone, joint, or muscle pain
• chest pain or tightness
• cough
• decreased frequency or amount of urine
• dizziness
• ear congestion
• fever or chills
• headache
• increased thirst
• loss of appetite
• loss of voice
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• runny or stuffy nose
• sneezing
• sore throat
• stomach pain
• swelling of the face, fingers, or lower legs
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain

Incidence not known

• chills
• general feeling of discomfort or illness
• thickening of bronchial secretions

Other side effects of Rydapt

Some side effects of midostaurin 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

• bloody nose
• blurred vision
• cracked lips
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• difficulty with swallowing
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased sweating
• increased thirst
• increased urination
• muscle stiffness
• small red or purple spots on the skin
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• sweating
• trouble sleeping
• unexplained weight loss

For healthcare professionals

Applies to midostaurin: oral capsule.

General adverse events

Acute Myeloid Leukemia (AML):

The most common laboratory abnormalities (incidence 10% or more and 2% or more frequent than placebo) were hypocalcemia, increased ALT, and hypernatremia.

The most frequent adverse reactions (incidence 20% or greater) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, and upper respiratory tract infections.

Systemic Mastocytosis/Mantle Cell Leukemia:

The most common laboratory abnormalities (incidence 49% or more) were hyperglycemia, lymphopenia, leukopenia, anemia, thrombocytopenia, and neutropenia.

The most frequent adverse reactions (incidence 20% or greater) were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (83%), vomiting (68%), mucositis/stomatitis (66%), diarrhea/gastroenteritis/colitis (54%), increased lipase (37%), abdominal pain (34%), constipation (29%), increased amylase (20%), hemorrhoids (15%), gastrointestinal/hemorrhoidal/duodenal ulcer hemorrhage (14%)
• Common (1% to 10%): Dyspepsia, gastritis^[Ref]

Hematologic

• Very common (10% or more): Febrile neutropenia (83%), lymphopenia (66%), leukopenia (61%), anemia (60%), thrombocytopenia (50%), neutropenia (49%), prolonged activated partial thromboplastin time (13%)^[Ref]

Endocrine

• Very common (10% or more): Hyperglycemia (80%)^[Ref]

Metabolic

• Very common (10% or more): Hypocalcemia (74%), hypernatremia (34%), hypoalbuminemia (27%), hypokalemia (25%), hyperkalemia (23%), hypophosphatemia (22%), hypomagnesemia (20%)
• Common (1% to 10%): Increased weight, hypercalcemia^[Ref]

Hepatic

• Very common (10% or more): Increased ALT (71%), increased alkaline phosphate (39%), increased GGT (35%), increased AST (32%), hyperbilirubinemia (29%)^[Ref]

Nervous system

• Very common (10% or more): Headache (46%), dizziness (13%)
• Common (1% to 10%): Tremor, vertigo^[Ref]

Other

• Very common (10% or more): Edema/peripheral edema (40%), fatigue/asthenia (34%), pyrexia (27%), device-related infection (24%)
• Common (1% to 10%): Chills, sepsis (staphylococcal/enterobacter/escherichia), fungal infection (bronchopulmonary aspergillosis, pneumonia fungal, splenic fungal, hepatic candidiasis)^[Ref]

Genitourinary

• Very common (10% or more): Hyperuricemia (37%), urinary tract infection/cystitis (16%)^[Ref]

Dermatologic

• Very common (10% or more): Petechiae (36%), rash/maculo-papular rash/erythema multiforme (14%), hyperhidrosis (14%)
• Common (1% to 10%): Cellulitis or erysipelas, dry skin, contusion^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal/back/bone/extremity pain (35%), arthralgia (19%)^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection/nasopharyngitis/sinusitis (30%), epistaxis (28%), dyspnea/bronchospasm/respiratory failure (23%), cough (18%), pleural effusion (13%), pneumonia/lung infection (10%), pneumonitis (11%)
• Common (1% to 10%): Bronchitis, oropharyngeal pain, interstitial lung disease, pulmonary edema/congestion^[Ref]

Renal

• Very common (10% or more): Increased creatinine (25%), renal insufficiency/failure (12%)^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (12%)
• Common (1% to 10%): Disturbance in attention, mental status changes^[Ref]

Cardiovascular

• Very common (10% or more): Prolonged QT (11%)
• Common (1% to 10%): Hypertension, hypotension, pericardial effusion, thrombosis, hematoma, cardiac failure, myocardial infarction or ischemia, angina pectoris^[Ref]

Immunologic

• Very common (10% or more): Herpes virus infection (10%)^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reaction, anaphylactic shock^[Ref]

Ocular

• Common (1% to 10%): Eyelid edema^[Ref]

Frequently asked questions

• What is Rydapt used to treat?

Further information

Rydapt 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