Rydapt Side Effects

Generic name: midostaurin

Medically reviewed by Drugs.com. Last updated on Apr 9, 2023.

Note: This document contains side effect information about midostaurin. Some dosage forms listed on this page may not apply 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

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

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

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]