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IMATINIB MESYLATE
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Postmarketing Experience
- The following additional adverse reactions have been identified during post approval use of imatinib mesylate tablets. 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.
- Infections: hepatitis B virus reactivation1
- Nervous System Disorders: cerebral edema1
- Eye Disorders: vitreous hemorrhage
- Cardiac Disorders: pericarditis, cardiac tamponade1
- Vascular Disorders: thrombosis/embolism, anaphylactic shock
- Respiratory, Thoracic and Mediastinal Disorders: acute respiratory failure1, interstitial lung disease
- Gastrointestinal Disorders: ileus/intestinal obstruction, tumor hemorrhage/tumor necrosis, gastrointestinal perforation1 [see Warnings and Precautions (5.6)], diverticulitis, gastric antral vascular ectasia
- Skin and Subcutaneous Tissue Disorders: lichenoid keratosis, lichen planus, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), pseudoporphyria
- Musculoskeletal and Connective Tissue Disorders: avascular necrosis/hip osteonecrosis, rhabdomyolysis/myopathy, growth retardation in children, musculoskeletal pain upon treatment discontinuation (including myalgia, pain in extremity, arthalgia, bone pain)
- Reproduction Disorders: hemorrhagic corpus luteum/hemorrhagic ovarian cyst
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
92
42820
Other ADRs
40334
14076945
Odds Ratio = 0.75
Drug Property Information
ATC Code(s):
- L01XE01 - imatinib mesylate
- L01XE - Protein kinase inhibitors
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:imatinib mesylate
Active Ingredient UNII:8A1O1M485B
Drugbank ID:DB00619
PubChem Compound:5291
CAS Number:152459-95-5
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
CC1=C(C=C(C=C1)NC(=O)C2=CC=C(C=C2)CN3CCN(CC3)C)NC4=NC=CC(=N4)C5=CN=CC=C5
CC1=C(C=C(C=C1)NC(=O)C2=CC=C(C=C2)CN3CCN(CC3)C)NC4=NC=CC(=N4)C5=CN=CC=C5
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: [Two cases of surgical resection of rectal gastrointestinal stromal tumor after neoadjuvant therapy with imatinib mesylate].
[Nakashima Susumu,Fujita Yuji,Matsuo Hisataka,Ariyoshi Yosuke,Fukuda Kenichiro,Fujiyama Junshin,Masuyama Mamoru]Gan To Kagaku Ryoho.2012 Nov;39(12):1932-4. PMID: 23267934
2: Sorafenib: muscle wasting.
Prescrire Int.2011 Dec;20(122):296-7. PMID: 22216546
3: Elevations of creatine kinase in patients treated with imatinib mesylate (Gleevec).
[Gordon Jessica K,Magid Steven K,Maki Robert G,Fleisher Martin,Berman Ellin]Leuk Res.2010 Jun;34(6):827-9. doi: 10.1016/j.leukres.2009.11.002. Epub 2009 Dec 5. PMID: 19963273
4: Imatinib as a possible cause of severe rhabdomyolysis.
[Penel Nicolas,Blay Jean-Yves,Adenis Antoine]N Engl J Med.2008 Jun 19;358(25):2746-7. doi: 10.1056/NEJMc0708896. PMID: 18565874
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