"The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases."...
Gleevec Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Gleevec (imatinib mesylate) is a kinase inhibitor that inhibits a protein signal that causes cancer cell proliferation. It is used to treat patients with hematological malignancies or malignant sarcomas such as Philadelphia positive chronic myeloid leukemia, chronic myeloid leukemia in blast crisis, acute lymphoblastic leukemia, aggressive systemic mastocytosis, gastrointestinal stromal tumors, and other diseases. The generic name for Gleevec is imatinib mesylate and is available outside of the US as a generic named imatinib. Common side effects if Gleevec are mild gastrointestinal symptoms of nausea, diarrhea, gas, muscle and/or joint discomfort, tired, mild skin rash, and flu-like symptoms.
Gleevec is supplied in 100 or 400 mg tablets. The dose is quite variable and depends on the disease being treated, age of patient (some doses based on mg per kilogram weight (mg/Kg). Doses usually range between 100 to 800 mg per day; high doses are divided into lower mg levels but are taken twice a day. Because the tablets have iron in the coating, high doses should use the 400 mg tablets to avoid getting too much iron. Gleevec should be taken with water and food. Gleevec should not be crushed or come in direct contact with skin as serious rashes may develop. Serious side effects can be severe blistering skin rashes, jaundice, gastrointestinal bleeding, weakness with shortness of breath, severe headaches, swelling, and severe flu-like symptoms. Development of these symptoms requires urgent medical evaluation. Gleevec should only be used under the guidance of a physician experienced in treating patients with malignant diseases. It is not safe to use this drug while pregnant; breastfeeding studies are unavailable. Use in children under the age of 18 is infrequent; consultation with a specialist (such as a pediatric oncologist) is recommended. Many medical conditions and drugs affect the levels of Gleevec in patients, so patients are urged to be sure the treating doctor has a complete medical history and medication list before the drug is prescribed.
Our Gleevec Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Gleevec in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- fever, chills, body aches, flu symptoms;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- swelling, rapid weight gain, feeling short of breath (even with mild exertion);
- black, bloody, or tarry stools;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- coughing up blood or vomit that looks like coffee grounds;
- lower back pain, blood in your urine;
- urinating less than usual or not at all;
- numbness or tingly feeling around your mouth;
- muscle weakness, tightness, or contraction, overactive reflexes;
- fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- mild nausea or stomach pain, vomiting, diarrhea;
- muscle cramps;
- joint or muscle pain;
- headache, feeling tired; or
- stuffy nose, sinus pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Gleevec (Imatinib Mesylate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Gleevec Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, fast/pounding heartbeat, extreme tiredness, sudden/unexplained weight gain, swelling (especially of lower legs/the area around eyes), increasing trouble breathing (shortness of breath).
Tell your doctor immediately if any of these rare but very serious side effects occur: black/bloody stools, dark urine, stomach/abdominal pain, vomit that looks like coffee grounds, yellowing eyes/skin.
This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.
Imatinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Tell your doctor immediately if you experience symptoms such as low back/side pain (flank pain), red/pinkish urine, painful urination, or muscle spasms/weakness.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Gleevec (Imatinib Mesylate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Gleevec FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice.
Chronic Myeloid Leukemia
The majority of Gleevec-treated patients experienced adverse reactions at some time. Most reactions were of mild-to-moderate grade, but drug was discontinued for drug-related adverse reactions in 2.4% of newly diagnosed patients, 4% of patients in chronic phase after failure of interferon-alpha therapy, 4% in accelerated phase and 5% in blast crisis.
The most frequently reported drug-related adverse reactions were edema, nausea and vomiting, muscle cramps, musculoskeletal pain, diarrhea and rash (Table 2 for newly diagnosed CML, Table 3 for other CML patients). Edema was most frequently periorbital or in lower limbs and was managed with diuretics, other supportive measures, or by reducing the dose of Gleevec. [see DOSAGE AND ADMINISTRATION]. The frequency of severe superficial edema was 1.5%-6%.
A variety of adverse reactions represent local or general fluid retention including pleural effusion, ascites, pulmonary edema and rapid weight gain with or without superficial edema. These reactions appear to be dose related, were more common in the blast crisis and accelerated phase studies (where the dose was 600 mg/day), and are more common in the elderly. These reactions were usually managed by interrupting Gleevec treatment and using diuretics or other appropriate supportive care measures. A few of these reactions may be serious or life threatening, and one patient with blast crisis died with pleural effusion, congestive heart failure, and renal failure.
Adverse reactions, regardless of relationship to study drug, that were reported in at least 10% of the Gleevec treated patients are shown in Tables 2 and 3.
Table 2 : Adverse Reactions Reported in Newly Diagnosed CML Clinical Trial ( ≥ 10% of Gleevec Treated Patients)(1)
|Preferred Term||All Grades||CTC Grades 3/4|
|- Superficial Edema||59.9||9.6||1.5||0.4|
|- Other Fluid Retention Reactions2||6.9||1.9||1.3||0.6|
|Rash and Related Terms||40.1||26.1||2.9||2.4|
|- GI Hemorrhage||1.6||1.1||0.5||0.2|
|- CNS Hemorrhage||0.2||0.4||0||0.4|
|Upper Respiratory Tract Infection||21.2||8.4||0.2||0.4|
|(1)All adverse reactions occurring
in ≥ 10% of Gleevec treated patients are listed regardless of suspected
relationship to treatment.
(2)Other fluid retention reactions include pleural effusion, ascites, pulmonary edema, pericardial effusion, anasarca, edema aggravated, and fluid retention not otherwise specified.
Table 3 : Adverse Reactions Reported in Other CML Clinical
Trials ( ≥ 10% of All Patients in any Trial)(1)
|Preferred Term||Myeloid Blast Crisis (n=260) %||Accelerated Phase (n=235) %||Chronic Phase, IFN Failure (n=532) %|
|All Grades||Grade 3/4||All Grades||Grade 3/4||All Grades||Grade 3/4|
|-Other Fluid Retention|
|- CNS Hemorrhage||9||7||3||3||2||1|
|- GI Hemorrhage||8||4||6||5||2||0.4|
|Upper Respiratory Tract Infection||3||0||12||0.4||19||0|
|(1) All adverse reactions occurring
in ≥ 10% of patients are listed regardless of suspected relationship
(2) Other fluid retention reactions include pleural effusion, ascites, pulmonary edema, pericardial effusion, anasarca, edema aggravated, and fluid retention not otherwise specified.
Cytopenias, and particularly neutropenia and thrombocytopenia, were a consistent finding in all studies, with a higher frequency at doses ≥ 750 mg (Phase 1 study). The occurrence of cytopenias in CML patients was also dependent on the stage of the disease.
In patients with newly diagnosed CML, cytopenias were less frequent than in the other CML patients (see Tables 4 and 5). The frequency of Grade 3 or 4 neutropenia and thrombocytopenia was between 2- and 3-fold higher in blast crisis and accelerated phase compared to chronic phase (see Tables 4 and 5). The median duration of the neutropenic and thrombocytopenic episodes varied from 2 to 3 weeks, and from 2 to 4 weeks, respectively.
These reactions can usually be managed with either a reduction of the dose or an interruption of treatment with Gleevec, but in rare cases require permanent discontinuation of treatment.
Table 4 : Lab Abnormalities in Newly Diagnosed CML Clinical
|Grade 3||Grade 4||Grade 3||Grade 4|
|- Elevated Creatinine||0||0||0.4||0|
|- Elevated Bilirubin||0.9||0.2||0.2||0|
|- Elevated Alkaline Phosphatase||0.2||0||0.8||0|
|- Elevated SGOT /SGPT||4.7||0.5||7.1||0.4|
|*p < 0.001 (difference in Grade 3 plus 4 abnormalities between the two treatment groups)|
Table 5 :Lab Abnormalities in Other CML Clinical Trials
|CTC Grades1||Myeloid Blast Crisis (n=260) 600 mg n=223 400 mg n=37 %||Accelerated Phase (n=235) 600 mg n=158 400 mg n=77 %||Chronic Phase, IFN Failure (n=532) 400mg %|
|Grade 3||Grade 4||Grade 3||Grade 4||Grade 3||Grade 4|
|- Thrombocytopenia||30||33||31||13||21||< 1|
|- Elevated Creatinine||1.5||0||1.3||0||0.2||0|
|- Elevated Bilirubin||3.8||0||2.1||0||0.6||0|
|- Elevated Alkaline Phosphatase||4.6||0||5.5||0.4||0.2||0|
|- Elevated SGOT (AST)||1.9||0||3.0||0||2.3||0|
|- Elevated SGPT (ALT)||2.3||0.4||4.3||0||2.1||0|
|1CTC Grades: neutropenia (Grade 3 ≥ 0.5-1.0 x 109/L, Grade 4 < 0.5 x 109/L), thrombocytopenia (Grade 3 ≥ 10-50 x 109/L, Grade 4 < 10 x 109/L), anemia (hemoglobin ≥ 65-80 g/L, Grade 4 < 65 g/L), elevated creatinine (Grade 3 > 3-6 x upper limit normal range [ULN], Grade 4 > 6 x ULN), elevated bilirubin (Grade 3 > 3-10 x ULN, Grade 4 > 10 x ULN), elevated alkaline phosphatase (Grade 3 > 5-20 x ULN, Grade 4 > 20 x ULN), elevated SGOT or SGPT (Grade 3 > 5-20 x ULN, Grade 4 > 20 x ULN)|
Severe elevation of transaminases or bilirubin occurred in approximately 5% of CML patients (see Tables 4 and 5) and were usually managed with dose reduction or interruption (the median duration of these episodes was approximately 1 week). Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1.0% of CML patients. One patient, who was taking acetaminophen regularly for fever, died of acute liver failure. In the Phase 2 GIST trial, Grade 3 or 4 SGPT (ALT) elevations were observed in 6.8% of patients and Grade 3 or 4 SGOT (AST) elevations were observed in 4.8% of patients. Bilirubin elevation was observed in 2.7% of patients.
Adverse Reactions in Pediatric Population
The overall safety profile of pediatric patients treated with Gleevec in 93 children studied was similar to that found in studies with adult patients, except that musculoskeletal pain was less frequent (20.5%) and peripheral edema was not reported. Nausea and vomiting were the most commonly reported individual adverse reactions with an incidence similar to that seen in adult patients. Although most patients experienced adverse reactions at some time during the study, the incidence of Grade 3/4 adverse reactions was low.
Adverse Reactions in Other Subpopulations
In older patients ( ≥ 65 years old), with the exception of edema, where it was more frequent, there was no evidence of an increase in the incidence or severity of adverse reactions. In women there was an increase in the frequency of neutropenia, as well as Grade ½ superficial edema, headache, nausea, rigors, vomiting, rash, and fatigue. No differences were seen that were related to race but the subsets were too small for proper evaluation.
Acute Lymphoblastic Leukemia
The adverse reactions were similar for Ph+ ALL as for Ph+ CML. The most frequently reported drug-related adverse reactions reported in the Ph+ ALL studies were mild nausea and vomiting, diarrhea, myalgia, muscle cramps and rash, which were easily manageable. Superficial edema was a common finding in all studies and were described primarily as periorbital or lower limb edemas. These edemas were rarely severe and may be managed with diuretics, other supportive measures, or in some patients by reducing the dose of Gleevec.
Adverse reactions, regardless of relationship to study drug, that were reported in at least 10% of the patients treated with Gleevec for MDS/MPD in the phase 2 study, are shown in Table 6.
Table 6 : Adverse Reactions Reported (More than One Patient)
in MPD Patients in the Phase 2 Study ( ≥ 10% All Patients) All Grades
|Preferred Term||N=7 n (%)|
|Muscle Cramp||3 (42.9)|
|Periorbital Edema||2 (28.6)|
Aggressive Systemic Mastocytosis
All ASM patients experienced at least one adverse reaction at some time. The most frequently reported adverse reactions were diarrhea, nausea, ascites, muscle cramps, dyspnea, fatigue, peripheral edema, anemia, pruritus, rash and lower respiratory tract infection. None of the 5 patients in the phase 2 study with ASM discontinued Gleevec due to drug-related adverse reactions or abnormal laboratory values.
Hypereosinophilic Syndrome and Chronic Eosinophilic Leukemia
The safety profile in the HES/CEL patient population does not appear to be different from the safety profile of Gleevec observed in other hematologic malignancy populations, such as Ph+ CML. All patients experienced at least one adverse reaction, the most common being gastrointestinal, cutaneous and musculoskeletal disorders. Hematological abnormalities were also frequent, with instances of CTC Grade 3 leukopenia, neutropenia, lymphopenia and anemia.
Adverse reactions, regardless of relationship to study drug, that were reported in at least 10% of the 12 patients treated with Gleevec for DFSP in the phase 2 study are shown in Table 7.
Table 7 : Adverse Reactions Reported in DFSP Patients in
the Phase 2 Study ( ≥ 10% All Patients) All Grades
|Preferred term||N=12 n (%)|
|Periorbital Edema||4 (33.3)|
|Face Edema||2 (16.7)|
|Edema Peripheral||4 (33.3)|
|Eye Edema||4 (33.3)|
|Lacrimation Increased||3 (25.0)|
|Dyspnea Exertional||2 (16.7)|
Clinically relevant or severe laboratory abnormalities in the 12 patients treated with Gleevec for DFSP in the phase 2 study are presented in Table 8.
Table 8 : Laboratory Abnormalities Reported in DFSP Patients
in the Phase 2 Study
|Grade 3||Grade 4|
|- Anemia||17 %||0 %|
|- Thrombocytopenia||17 %||0 %|
|- Neutropenia||0 %||8 %|
|- Elevated Creatinine||0 %||8 %|
|1CTC Grades: neutropenia (Grade 3 ≥ 0.5-1.0 x 109/L, Grade 4 < 0.5 x 109/L), thrombocytopenia (Grade 3 ≥ 10 - 50 x 109/L, Grade 4 < 10 x 109/L), anemia (Grade 3 ≥ 65-80 g/L, Grade 4 < 65 g/L), elevated creatinine (Grade 3 > 3-6 x upper limit normal range [ULN], Grade 4 > 6 x ULN),|
Gastrointestinal Stromal Tumors
Unresectable and/or Malignant Metastatic GIST
In the Phase 3 trials the majority of Gleevec-treated patients experienced adverse reactions at some time. The most frequently reported adverse reactions were edema, fatigue, nausea, abdominal pain, diarrhea, rash, vomiting, myalgia, anemia and anorexia. Drug was discontinued for adverse reactions in a total of 89 patients (5.4%). Superficial edema, most frequently periorbital or lower extremity edema was managed with diuretics, other supportive measures, or by reducing the dose of Gleevec [see DOSAGE AND ADMINISTRATION]. Severe (CTC Grade 3/4) edema was observed in 182 patients (11.1%).
Adverse reactions, regardless of relationship to study drug, that were reported in at least 10% of the patients treated with Gleevec are shown in Table 9.
Overall the incidence of all grades of adverse reactions and the incidence of severe adverse reactions (CTC Grade 3 and above) were similar between the two treatment arms except for edema, which was reported more frequently in the 800 mg group.
Table 9 :Number (%) of Patients with Adverse Reactions where
Frequency is ≥ 10% in any One Group (Full Analysis Set) in the Phase 3 Unresectable
and/or Malignant Metastatic GIST Clinical Trials
|Reported or Specified Term||Imatinib 400 mg N=818||Imatinib 800 mg N=822|
|All Grades %||Grades 3/4/5 %||All Grades %||Grades 3/4/5 %|
|Fatigue/lethargy, malaise, asthenia||69.3||11.7||74.9||12.2|
|Other GI toxicity||25.2||8.1||28.1||6.6|
|Other pain (excluding tumor related pain)||20.4||5.9||20.8||5.0|
|Other dermatology /skin toxicity||17.6||5.9||20.1||5.7|
|Other constitutional symptoms||16.7||6.4||15.2||4.4|
|Infection (without neutropenia)||15.5||6.6||16.5||5.6|
|Other neurological toxicity||15.0||6.4||15.2||4.9|
|Other renal/genitourinary toxicity||14.2||6.5||13.6||5.2|
|Arthralgia (joint pain)||13.6||4.8||12.3||3.0|
|Dyspnea (shortness of breath)||13.6||6.8||14.2||5.6|
|Fever in absence of neutropenia (ANC < 1.0 x 109/L)||13.2||4.9||12.9||3.4|
|Stomatitis/pharyngitis (oral/pharyngeal mucositis)||9.2||5.4||10.0||4.3|
Clinically relevant or severe abnormalities of routine hematologic or biochemistry laboratory values were not reported or evaluated in the Phase 3 GIST trials. Severe abnormal laboratory values reported in the Phase 2 GIST trial are presented in Table 10.
Table 10 : Laboratory Abnormalities in the Phase 2 Unresectable
and/or Malignant Metastatic GIST Trial
|CTC Grades1||400 mg (n=73) %||600 mg (n=74) %|
|Grade 3||Grade 4||Grade 3||Grade 4|
|- Elevated Creatinine||0||0||3||0|
|- Reduced Albumin||3||0||4||0|
|- Elevated Bilirubin||1||0||1||3|
|- Elevated Alkaline Phosphatase||0||0||3||0|
|- Elevated SGOT (AST)||4||0||3||3|
|- Elevated SGPT (ALT)||6||0||7||1|
|1CTC Grades: neutropenia (Grade 3 ≥ 0.5-1.0 x 109/L, Grade 4 < 0.5 x 109/L), thrombocytopenia (Grade 3 ≥ 10 - 50 x 109/L, Grade 4 < 10 x 109/L), anemia (Grade 3 ≥ 65-80 g/L, Grade 4 < 65 g/L), elevated creatinine (Grade 3 > 3-6 x upper limit normal range [ULN], Grade 4 > 6 x ULN), elevated bilirubin (Grade 3 > 3-10 x ULN, Grade 4 > 10 x ULN), elevated alkaline phosphatase, SGOT or SGPT (Grade 3 > 5-20 x ULN, Grade 4 > 20 x ULN), albumin (Grade 3 < 20 g/L)|
Adjuvant Treatment of GIST
The majority of both Gleevec and placebo treated patients experienced at least one adverse reaction at some time. The most frequently reported adverse reactions were similar to those reported in other clinical studies in other patient populations and include diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting and abdominal pain. No new adverse reactions were reported in the adjuvant GIST treatment setting that had not been previously reported in other patient populations including patients with unresectable and/or malignant metastatic GIST. Drug was discontinued for adverse reactions in 57 patients (17%) and 11 patients (3%) of the Gleevec and placebo treated patients respectively. Edema, gastrointestinal disturbances (nausea, vomiting, abdominal distention and diarrhea), fatigue, low hemoglobin and rash were the most frequently reported adverse reactions at the time of discontinuation.
Adverse reactions, regardless of relationship to study drug, that were reported in at least 5% of the patients treated with Gleevec are shown in Table 11.
Table 11: Adverse Reactions Reported in the Adjuvant GIST
Trial ( ≥ 5% of Gleevec Treated Patients)(1)
|Preferred Term||All CTC Grades||CTC Grade 3 and above|
|Liver enzymes (ALT) Increased||16.6||13.0||2.7||0|
|Neutrophil Count Decreased||16.0||6.1||3.3||0.9|
|White Blood Cell Count Decreased||14.5||4.3||0.6||0.3|
|Liver Enzymes (AST) Increased||12.2||7.5||2.1||0|
|Blood Creatinine Increased||11.6||5.8||0||0.3|
|Pain in Extremity||7.4||7.2||0.3||0|
|Blood Alkaline Phosphatase Increased||6.5||7.5||0||0|
|Abdominal Pain Upper||6.2||6.4||0.3||0|
|Platelet Count Decreased||5.0||3.5||0||0|
|Upper Respiratory Tract Infection||5.0||3.5||0||0|
|(1)All adverse reactions occurring in ≥ 5% of patients are listed regardless of suspected relationship to treatment. A patient with multiple occurrences of an adverse reaction is counted only once in the adverse reaction category.|
Additional Data from Multiple Clinical Trials
The following adverse reactions have been reported during clinical trials of Gleevec.
Estimated 1%-10%: flushing, hemorrhage
Clinical Laboratory Tests:
Estimated 0.1%-1%: blood CPK increased, blood LDH increased,
Estimated 0.01%-0.1%: blood amylase increased
Estimated 1%-10%: dry skin, alopecia, face edema, erythema, photosensitivity reaction, Estimated 0.1%-1%: exfoliative dermatitis, bullous eruption, nail disorder, purpura, psoriasis, rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, skin hyperpigmentation, onychoclasis, folliculitis, petechiae
Estimated 0.01%-0.1%: vesicular rash, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discoloration, angioneurotic edema, erythema multiforme, leucocytoclastic vasculitis
General Disorders and Administration Site Conditions:
Estimated 1%-10%: weakness, anasarca, chills
Estimated 0.1%-1%: malaise
Estimated 1%-10%: pancytopenia, febrile neutropenia
Estimated 0.01%-0.1%: hepatic failure and hepatic necrosis1
Estimated 0.01%-0.1%: angioedema Infections:
Estimated 0.01%-0.1%: fungal infection
Metabolic and Nutritional:
Estimated 1%-10%: weight decreased
Estimated 1%-10%: joint swelling
Estimated 0.1%-1%: joint and muscle stiffness
Estimated 0.01%-0.1%: muscular weakness, arthritis
Estimated 1%-10%: paresthesia, hypesthesia
Estimated 0.01%-0.1%: increased intracranial pressure1, confusional state, convulsions, optic neuritis
Estimated 0.1%-1%: renal failure acute, urinary frequency increased, hematuria, renal pain
Respiratory: Estimated 1%-10%: epistaxis
Estimated 0.1%-1%: pleural effusion
1Including some fatalities
The following additional adverse reactions have been identified during post approval use of Gleevec. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous system disorders: cerebral edema1
Eye disorders: vitreous hemorrhage
Vascular disorders: thrombosis/embolism, anaphylactic shock
Respiratory, thoracic and mediastinal disorders: acute respiratory failure1, interstitial lung disease
Skin and subcutaneous tissue disorders: lichenoid keratosis, lichen planus, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia syndrome
Musculoskeletal and connective tissue disorders: avascular necrosis/hip osteonecrosis, rhabdomyolysis/myopathy, growth retardation in children
1Including some fatalities
Read the entire FDA prescribing information for Gleevec (Imatinib Mesylate) »
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