Cellulitis, Pyrexia, Vomiting +1
Drugs: IMBRUVICA, ERYTHROPOIETIN, LOSARTAN
- Safetyreportversion
- 1
- Safetyreportid
- 26940094
- Primarysourcecountry
- CO
- Occurcountry
- CO
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 2
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 1
- Companynumb
- CO-JNJFOC-20260631476
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- Janssen R+D
- Duplicatenumb
- CO-JNJFOC-20260631476
- Primarysource
- Reportercountry
- CO
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- ABBVIE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 30
- Patientonsetageunit
- 801
- Patientweight
- 73
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Cellulitis
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pyrexia
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Vomiting
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Diarrhoea
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- IMBRUVICA
- Drugbatchnumb
- Not available
- Drugauthorizationnumb
- 210563
- Drugstructuredosagenumb
- 420
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- LAST DELIVERY DATE: 21-MAY-2026.
- Drugdosageform
- Tablet
- Drugindication
- Chronic lymphocytic leukaemia
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- IBRUTINIB
- Harmonized identifiers (openFDA)
- Application number
- NDA217003, NDA210563, NDA205552
- Brand name
- IMBRUVICA
- Generic name
- IBRUTINIB
- Manufacturer name
- Pharmacyclics LLC
- Product NDC
- 57962-007, 57962-070, 57962-140, 57962-014, 57962-280, 57962-420
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- IBRUTINIB
- RxCUI
- 1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023, 2000025, 2000027, 2611536, 2611540
- SPL ID
- 43280dcb-52ae-40e4-bd52-723f71f74ab7
- SPL set ID
- 0dfd0279-ff17-4ea9-89be-9803c71bab44
- Package NDC
- 57962-070-28, 57962-140-09, 57962-140-12, 57962-014-28, 57962-280-28, 57962-420-28, 57962-420-71, 57962-007-12
- Nui
- N0000175605, N0000175076
- Pharm class epc
- Kinase Inhibitor [EPC]
- Pharm class moa
- Protein Kinase Inhibitors [MoA]
- UNII
- 1X70OSD4VX
- Drugcharacterization
- 2
- Medicinalproduct
- ERYTHROPOIETIN
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- ERYTHROPOIETIN
- Harmonized identifiers (openFDA)
- Application number
- BLA103234
- Brand name
- PROCRIT
- Generic name
- ERYTHROPOIETIN
- Manufacturer name
- Janssen Products, LP
- Product NDC
- 59676-302, 59676-303, 59676-304, 59676-310, 59676-340, 59676-312, 59676-320
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Substance name
- EPOETIN
- RxCUI
- 205913, 205918, 205922, 205924, 212219, 213475, 239998, 239999, 240000, 240377, 241999, 242706, 1721684, 1721690
- SPL ID
- 325d5d88-413d-28a2-e063-6394a90a3948
- SPL set ID
- 0c721ba4-ae19-417f-aae1-221ed1a0866a
- Package NDC
- 59676-303-00, 59676-303-01, 59676-304-00, 59676-304-01, 59676-310-00, 59676-310-01, 59676-310-02, 59676-302-00, 59676-302-01, 59676-340-00, 59676-340-01, 59676-312-00, 59676-312-04, 59676-320-00, 59676-320-04
- UNII
- 64FS3BFH5W
- Drugcharacterization
- 2
- Medicinalproduct
- LOSARTAN
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- LOSARTAN
- Harmonized identifiers (openFDA)
- Application number
- ANDA215959
- Brand name
- LOSARTAN POTASSIUM
- Generic name
- LOSARTAN
- Manufacturer name
- Granules Pharmaceuticals Inc., Granules India Ltd
- Product NDC
- 70010-741, 70010-742, 70010-743, 62207-741, 62207-742, 62207-743
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LOSARTAN POTASSIUM
- RxCUI
- 979480, 979485, 979492
- SPL ID
- 451da3de-077d-522d-e063-6394a90a3537, 39e0a359-f9d7-c3fb-e063-6394a90a86a8
- SPL set ID
- ca012edc-923d-4ada-a261-db82b71b3c4f, f9953f51-f30a-952d-e053-6394a90abf5f
- Package NDC
- 70010-741-03, 70010-741-09, 70010-741-10, 70010-742-03, 70010-742-09, 70010-742-10, 70010-743-03, 70010-743-09, 70010-743-10, 62207-741-54, 62207-741-49, 62207-742-54, 62207-742-49, 62207-743-54, 62207-743-49
- UNII
- 3ST302B24A
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260623