Glasdegib side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of DAURISMO?

DAURISMO can cause serious side effects, including: • See " What is the most important information I should know about DAURISMO? " • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with DAURISMO. • Muscle Problems. Muscle problems are common with DAURISMO, but can also sometimes be serious. DAURISMO can increase your risk of muscle pain or muscle spasms. Tell your healthcare provider right away if you develop any new or worsening muscle spasms, pain, tenderness or weakness during and after treatment with DAURISMO. […]

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥20%) are anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash.

Table 3. Adverse Reactions Occurring in ≥10% of Patients Adverse reactions with ≥10% incidence in the DAURISMO with low-dose cytarabine arm or the low-dose cytarabine arm are included. No Grade 5 events in the DAURISMO…

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically-significant adverse reactions are described elsewhere in the labeling: • QTc Interval Prolongation [see Warnings and Precautions (5.2) ] • Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥20%) are anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety profile of DAURISMO is based on experience in the BRIGHT AML 1003 study for 111 adults with newly-diagnosed AML and 14 adults with other conditions for which DAURISMO is not indicated [see Clinical Studies (14) ]. Patients were treated with DAURISMO 100 mg daily in combination with low-dose cytarabine (N=84) or low-dose cytarabine alone (N=41). …

What do FAERS reports show?

468 reports list glasdegib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 190 are coded as a death and 224 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Death (an outcome recorded in the report)110
• Febrile Neutropenia (named in the label)69
• Pneumonia (named in the label)48
• Off Label Use (a use or a product term, not a reaction)34
• Neoplasm Progression28
• Neutropenia (named in the label)22
• Sepsis (named in the label)15
• Toxicity To Various Agents13
• Electrocardiogram Qt Prolonged12
• Product Use In Unapproved Indication (a use or a product term, not a reaction)11
• Septic Shock11
• Decreased Appetite (named in the label)10
• Drug Ineffective (a use or a product term, not a reaction)10
• Infection (named in the label)10
• Pyrexia (named in the label)10
• Diarrhoea (named in the label)9
• Platelet Count Decreased (named in the label)9
• Hyponatraemia (named in the label)8
• Mucosal Inflammation (named in the label)8
• Nausea (named in the label)8
• Pancytopenia8
• Product Use Issue (a use or a product term, not a reaction)8
• Thrombocytopenia (named in the label)8
• Acute Kidney Injury (named in the label)7
• Disease Progression (a use or a product term, not a reaction)7

What next?

Glasdegib: the full record

label, generics, price, shortages, recalls

Report a side effect to the FDA

MedWatch

Side effects hub

the most reported medicines and reactions