Drug adverse event reports (FAERS)

Neutropenia

Drugs: IBRUTINIB, VANDETANIB, PANOBINOSTAT +65

SeriousDeathHospitalizationLife-threatening
Safetyreportversion
1
Safetyreportid
27325180
Primarysourcecountry
CN
Occurcountry
CN
Transmissiondateformat
102
Transmissiondate
20261008
Reporttype
1
Serious
1
Seriousnessdeath
1
Seriousnesslifethreatening
1
Seriousnesshospitalization
1
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
CN-ABBVIE-6954135
Duplicate
1
Reportduplicate
  1. Duplicatesource
    Amgen
    Duplicatenumb
    CN-AMGEN-CNPM2026212556
  2. Duplicatesource
    Janssen R+D
    Duplicatenumb
    CN-JNJFOC-20260703138
  3. Duplicatesource
    Takeda
    Duplicatenumb
    CN-AMGEN-CNPM2026212556
Primarysource
Reportercountry
CN
Qualification
3
Literaturereference

Li J, Wang Y, Gao L, Jia J, Liu J, Jiang Z. Drug-induced neutropenia: A comprehensive pharmacovigilance study of the FAERS database. Medicine. 2026;105(16):e48434. Doi:10.1097/MD.0000000000048434

Sender
Sendertype
6
Senderorganization
ABBVIE
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Neutropenia
    Reactionoutcome
    5
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    IBRUTINIB
    Drugbatchnumb
    Not available
    Drugauthorizationnumb
    205552
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    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
  2. Drugcharacterization
    1
    Medicinalproduct
    VANDETANIB
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    VANDETANIB
    Harmonized identifiers (openFDA)
    Application number
    NDA022405
    Brand name
    CAPRELSA
    Generic name
    VANDETANIB
    Manufacturer name
    Genzyme Corporation
    Product NDC
    58468-7820, 58468-7840
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    VANDETANIB
    RxCUI
    1098416, 1098418, 1114074, 1114096
    SPL ID
    abb9eb38-c6a9-49e9-8e90-852f95773feb
    SPL set ID
    e5721cb8-4185-47b9-bbb3-1c587e558a03
    Package NDC
    58468-7820-3, 58468-7840-3
    Nui
    N0000175605, N0000175076, N0000185503, N0000187061
    Pharm class epc
    Kinase Inhibitor [EPC]
    Pharm class moa
    Protein Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
    UNII
    YO460OQ37K
  3. Drugcharacterization
    1
    Medicinalproduct
    PANOBINOSTAT
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    PANOBINOSTAT
  4. Drugcharacterization
    1
    Medicinalproduct
    VENETOCLAX
    Drugbatchnumb
    Not available
    Drugauthorizationnumb
    208573
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    VENETOCLAX
    Harmonized identifiers (openFDA)
    Application number
    NDA208573
    Brand name
    VENCLEXTA
    Generic name
    VENETOCLAX
    Manufacturer name
    AbbVie Inc.
    Product NDC
    0074-0561, 0074-0579, 0074-0576, 0074-0566
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    VENETOCLAX
    RxCUI
    1747561, 1747567, 1747572, 1747574, 1747575, 1747577, 1747579, 1747580
    SPL ID
    5d893369-497c-46ee-9b64-ee737fab4225
    SPL set ID
    b118a40d-6b56-cee3-10f6-ded821a97018
    Package NDC
    0074-0579-28, 0074-0576-22, 0074-0576-11, 0074-0576-34, 0074-0576-30, 0074-0561-14, 0074-0561-11, 0074-0566-07, 0074-0566-11
    Nui
    N0000192515, N0000009176, N0000185503
    Pharm class epc
    BCL-2 Inhibitor [EPC]
    Pharm class pe
    Increased Cellular Death [PE]
    Pharm class moa
    P-Glycoprotein Inhibitors [MoA]
    UNII
    N54AIC43PW
  5. Drugcharacterization
    1
    Medicinalproduct
    TRASTUZUMAB EMTANSINE
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    TRASTUZUMAB EMTANSINE
  6. Drugcharacterization
    1
    Medicinalproduct
    TISAGENLECLEUCEL
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    TISAGENLECLEUCEL
  7. Drugcharacterization
    1
    Medicinalproduct
    TRASTUZUMAB DERUXTECAN
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    TRASTUZUMAB DERUXTECAN
  8. Drugcharacterization
    1
    Medicinalproduct
    TALAZOPARIB
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    TALAZOPARIB
    Harmonized identifiers (openFDA)
    Application number
    NDA217439, NDA211651
    Brand name
    TALZENNA
    Generic name
    TALAZOPARIB
    Manufacturer name
    U.S. Pharmaceuticals
    Product NDC
    63539-025, 63539-031, 63539-295, 63539-051
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    ORAL
    Substance name
    TALAZOPARIB TOSYLATE
    RxCUI
    2099954, 2099956, 2591510, 2591512
    SPL ID
    b653221e-971f-4452-92d4-797924f1ff59, 245347ef-49f2-4b24-9892-b43489562a46
    SPL set ID
    b653221e-971f-4452-92d4-797924f1ff59, 13839d4f-6acf-4ffb-a128-79df59319273
    Package NDC
    63539-025-30, 63539-031-30, 63539-295-30, 63539-051-30
    UNII
    02WK9U5NZC
  9. Drugcharacterization
    1
    Medicinalproduct
    SACITUZUMAB GOVITECAN
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    SACITUZUMAB GOVITECAN
    Harmonized identifiers (openFDA)
    Application number
    BLA761115
    Brand name
    TRODELVY
    Generic name
    SACITUZUMAB GOVITECAN
    Manufacturer name
    Gilead Sciences, Inc.
    Product NDC
    55135-132
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    SACITUZUMAB GOVITECAN
    RxCUI
    2360534, 2360539
    SPL ID
    2085d741-19ba-4115-bbe9-0debac82c204
    SPL set ID
    57a597d2-03f0-472e-b148-016d7169169d
    Package NDC
    55135-132-01
    UNII
    M9BYU8XDQ6
  10. Drugcharacterization
    1
    Medicinalproduct
    PRALATREXATE
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    PRALATREXATE
    Harmonized identifiers (openFDA)
    Application number
    NDA022468, ANDA206183
    Brand name
    PRALATREXATE
    Generic name
    PRALATREXATE
    Manufacturer name
    Fresenius Kabi USA, LLC, Dr.Reddy's Laboratories Inc.,
    Product NDC
    65219-550, 65219-552, 43598-342, 43598-343
    Product type
    HUMAN PRESCRIPTION DRUG
    Route
    INTRAVENOUS
    Substance name
    PRALATREXATE
    RxCUI
    1796419, 1796424
    SPL ID
    510bc71b-20e4-428a-8fc2-29c9fc20f2f3, b885a7b3-a241-638d-8f27-d162c562469a
    SPL set ID
    a5daa583-4965-4564-ad87-41ffe6c08a11, cc3df863-c51c-49c5-283a-d6808fb49258
    Package NDC
    65219-550-01, 65219-552-02, 43598-342-11, 43598-343-23
    Nui
    N0000175584
    Pharm class epc
    Folate Analog Metabolic Inhibitor [EPC]
    UNII
    A8Q8I19Q20
  11. Drugcharacterization
    1
    Medicinalproduct
    THALIDOMIDE
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    THALIDOMIDE
  12. Drugcharacterization
    1
    Medicinalproduct
    THIOGUANINE ANHYDROUS
    Drugbatchnumb
    Not available
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugindication
    Product used for unknown indication
    Actiondrug
    6
    Drugadditional
    4
    Activesubstance
    Activesubstancename
    THIOGUANINE ANHYDROUS
  13. +56 more not shown
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.