Neutropenia
Drugs: IBRUTINIB, EPIRUBICIN, ESTRAMUSTINE +64
- Safetyreportversion
- 1
- Safetyreportid
- 27325179
- 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-6954134
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- Amgen
- Duplicatenumb
- CN-AMGEN-CNPM2026212556
- Duplicatesource
- Janssen R+D
- Duplicatenumb
- CN-JNJFOC-20260703138
- 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
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Neutropenia
- Reactionoutcome
- 5
- Drug
- 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
- Drugcharacterization
- 1
- Medicinalproduct
- EPIRUBICIN
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- EPIRUBICIN
- Drugcharacterization
- 1
- Medicinalproduct
- ESTRAMUSTINE
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ESTRAMUSTINE
- Drugcharacterization
- 1
- Medicinalproduct
- ZOLACABTAGENE AUTOLEUCEL
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ZOLACABTAGENE AUTOLEUCEL
- Drugcharacterization
- 1
- Medicinalproduct
- EPCORITAMAB
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- EPCORITAMAB
- Drugcharacterization
- 1
- Medicinalproduct
- IRINOTECAN HYDROCHLORIDE
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- IRINOTECAN HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA091032, ANDA203380, ANDA077915, ANDA077776, ANDA212993, ANDA090675, ANDA078589, ANDA213278, NDA020571, NDA207793
- Brand name
- IRINOTECAN HYDROCHLORIDE, CAMPTOSAR, ONIVYDE
- Generic name
- IRINOTECAN HYDROCHLORIDE
- Manufacturer name
- Hikma Pharmaceuticals USA Inc., Apotex Corp., Hospira, Inc., Fresenius Kabi USA, LLC, Northstar Rx LLC, Qilu Pharmaceutical Co., Ltd., Sagent Pharmaceuticals, Actavis Pharma, Inc., Eugia US LLC, Gland Pharma Limited, Pharmacia & Upjohn Company LLC, Xiromed LLC, Ipsen Biopharmaceuticals, Inc.
- Product NDC
- 0143-9701, 0143-9702, 0143-9583, 60505-6272, 61703-349, 63323-193, 16714-027, 16714-131, 67184-0511, 67184-0512, 67184-0513, 25021-230, 45963-614, 55150-352, 55150-353, 55150-354, 55150-355, 60505-6128, 68083-382, 68083-381, 0009-0112, 0009-7529, 0009-0082, 70700-170, 70700-169, 15054-0043
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- IRINOTECAN HYDROCHLORIDE
- RxCUI
- 1726319, 1726324, 1726492, 1726333, 1726321, 1726325, 1726335, 1719772, 1719777
- SPL ID
- 204eb37a-642f-4321-9466-414c32a6bbce, e36c07c2-a7ad-4d59-bdcc-fe16765b264b, c313857d-e43f-4500-8766-6037fb68ad9e, 9c52ca8e-58dd-4117-a5bc-f277e79abb19, 4e0a18c8-35aa-447c-bd91-b81d7d494d8e, 7d7ed052-95ae-6d58-f41f-ada9f8f97b81, 5faaf9ca-ed20-4ebf-9e7f-1d3a0ca60056, beff4b0b-e884-4134-ba9e-290020a94add, 3bbdb61c-9194-416e-9034-5d2b11b5b8ee, 2fc24d11-bf17-4007-8a65-d949793a972e, d2676b1a-30fb-456b-bb51-fb76fb64cf2d, a1ced9af-9117-485c-925d-47f7266bc9df, 6f05fe24-191a-4273-ad62-4ab6b5324062, 4b364426-00fb-0ef1-e063-6394a90aaba6, 72b1786a-3437-4799-8214-f37b5be5607c
- SPL set ID
- be716692-6b4f-47b6-83d1-01665861626b, 9c6aa884-750e-4b11-9955-bc7ab6e9c2ad, 8fe98987-e526-4729-a8f4-c7230f424108, 5c527c2e-9062-4afe-dbbb-f650db3a340f, ee45f127-8450-4455-a945-a1f5707f1d39, 4f98e9ed-f7b1-5346-af72-fccb0abf3f4b, afcdde49-ec0c-4c56-a1af-2917185b1a08, caab50e6-0dad-4ddd-9a6c-96cc2b87aee7, 5e1fdcaa-918f-4cd8-9c7a-4c538d866198, 7a30d551-9ea7-47ea-9073-f541bff457a3, 85ed6019-f462-4abe-a89e-ad991623c86d, de634e80-328a-4473-b395-0172683a2411, e518dfc6-7e93-4fee-a66c-51e1ab71c056, b26e5d27-dba5-7538-9e7b-48b358998cbb, c8b58efa-1820-48a4-b70d-62918fc4abfc
- Package NDC
- 0143-9702-01, 0143-9701-01, 0143-9583-01, 60505-6272-1, 61703-349-16, 61703-349-09, 61703-349-36, 63323-193-52, 63323-193-55, 16714-027-01, 16714-131-01, 67184-0511-1, 67184-0512-1, 67184-0513-1, 25021-230-02, 25021-230-05, 45963-614-51, 45963-614-55, 55150-352-01, 55150-353-01, 55150-354-01, 55150-355-01, 60505-6128-0, 60505-6128-1, 68083-381-01, 68083-382-01, 0009-7529-04, 0009-7529-03, 0009-7529-05, 0009-7529-10, 0009-0112-05, 0009-0082-02, 70700-169-22, 70700-170-22, 15054-0043-1
- UNII
- 042LAQ1IIS
- Drugcharacterization
- 1
- Medicinalproduct
- LETROZOLE
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- LETROZOLE
- Harmonized identifiers (openFDA)
- Application number
- ANDA090934, ANDA091191, ANDA211717, ANDA200161, ANDA090289, ANDA205869, NDA020726
- Brand name
- LETROZOLE, FEMARA
- Generic name
- LETROZOLE, LETROZOLE TABLETS
- Manufacturer name
- Accord Healthcare, Inc., Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limited, Natco Pharma Limited, Teva Pharmaceuticals USA, Inc., Chartwell RX, LLC, Breckenridge Pharmaceutical, Inc., Novartis Pharmaceuticals Corporation, Avet Pharmaceuticals Inc., Yiling Pharmaceutical, Inc., Upsher-Smith Laboratories, LLC, Carnegie Pharmaceuticals LLC
- Product NDC
- 16729-034, 55111-646, 59651-180, 63850-0025, 0093-7620, 62135-491, 51991-759, 0078-0249, 23155-875, 69117-0004, 24979-726, 80005-139
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LETROZOLE
- RxCUI
- 200064, 153124
- SPL ID
- 4a681bf4-9779-a1b2-e063-6294a90a83db, ec1b249b-2d77-55d9-0520-23884a961cf0, 2cd5dbfd-2432-4cea-bee2-6b710b5d28a2, 7917d6e0-df93-4c10-97c9-3d90b00b7bd4, c91fb703-e253-490e-bb1d-48d054d81c6e, 456ed484-059b-2ee9-e063-6294a90a3f83, 1bd709a7-993a-4e55-9bb5-d5f42678e7b9, 28456311-e797-457f-8a9e-54dca5a7a336, 40009527-770b-8999-e063-6294a90a9946, 4721d1b1-3a04-27fb-e063-6394a90a7c1a, 4d5cb59c-11c3-4b0d-e063-6294a90a5b87, 9fb66539-2efe-47cc-9b78-85b096caac95
- SPL set ID
- c391fe11-fd47-4a35-af6d-c823ab7b8838, 6cfd29d7-f519-7b8c-4814-07b39f367f0d, ff7325d2-3383-4ff9-a187-9350e3538640, 35c73219-c39e-4e10-b944-76009b061e79, 8ebda73d-82a3-4b17-8a81-a1f258003d32, fa2d40a5-3504-44ef-8f5c-aa4c06308074, 63e54b62-a30d-4a56-9215-75e7a0b0bf02, 82b77d74-085f-45ac-a7dd-1f5c038bf406, fe0e4d4b-436d-a36d-e053-6294a90a973d, 7b00e08c-9a1c-09e0-e053-2a91aa0a7638, 2d1f18f0-2c77-407c-b702-2d1b07f92510, cb1da0ac-8db1-4482-824d-430511d1b7a0
- Package NDC
- 16729-034-10, 16729-034-15, 16729-034-01, 16729-034-16, 16729-034-17, 16729-034-43, 55111-646-30, 55111-646-79, 55111-646-78, 59651-180-30, 59651-180-90, 63850-0025-1, 63850-0025-4, 0093-7620-56, 62135-491-30, 62135-491-90, 51991-759-33, 51991-759-10, 51991-759-90, 0078-0249-15, 23155-875-03, 23155-875-09, 23155-875-10, 69117-0004-1, 24979-726-07, 80005-139-08, 80005-139-10
- Nui
- N0000175563, N0000175080
- Pharm class epc
- Aromatase Inhibitor [EPC]
- Pharm class moa
- Aromatase Inhibitors [MoA]
- UNII
- 7LKK855W8I
- Drugcharacterization
- 1
- Medicinalproduct
- GLOFITAMAB
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- GLOFITAMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761309
- Brand name
- COLUMVI
- Generic name
- GLOFITAMAB
- Manufacturer name
- Genentech, Inc.
- Product NDC
- 50242-125, 50242-127
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- GLOFITAMAB
- RxCUI
- 2639786, 2639792, 2639794, 2639795
- SPL ID
- 33693fc1-cb24-4ce6-8ceb-b34ebf3536c0
- SPL set ID
- 3516e753-f064-4d30-9bd5-e3f2e143f75d
- Package NDC
- 50242-127-01, 50242-125-01
- Nui
- N0000194063, N0000175078, N0000175617, N0000175618, N0000009267, N0000182136
- Pharm class epc
- Bispecific CD20-directed CD3 T Cell Engager [EPC]
- Pharm class moa
- CD20-directed Antibody Interactions [MoA], CD3-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], Cytochrome P450 Inhibitors [MoA]
- Pharm class pe
- Increased Cytokine Activity [PE]
- UNII
- 06P3KLK2J8
- Drugcharacterization
- 1
- Medicinalproduct
- MYCOPHENOLIC ACID
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- MYCOPHENOLIC ACID
- Harmonized identifiers (openFDA)
- Application number
- ANDA211173, ANDA208315, NDA050791, ANDA091248, ANDA214376, ANDA214630, ANDA091558, ANDA217031, ANDA216637
- Brand name
- MYCOPHENOLIC ACID, MYFORTIC
- Generic name
- MYCOPHENOLIC ACID, MYCOPHENILIC ACID
- Manufacturer name
- CONCORD BIOTECH LIMITED, Ascend Laboratories, LLC, Stellon Biotech Inc., Novartis Pharmaceuticals Corporation, Archis Pharma LLC, Slate Run Pharmaceuticals, LLC, Biocon Pharma Inc., Apotex Corp, Advagen Pharma Limited, Novugen Pharma (USA) LLC.
- Product NDC
- 68254-5001, 68254-5002, 67877-426, 67877-427, 85972-161, 85972-162, 0078-0385, 0078-0386, 67877-928, 67877-929, 72819-155, 72819-156, 70436-172, 70436-173, 70377-039, 70377-040, 60505-2965, 60505-2966, 70377-126, 70377-127, 72888-199, 72888-200, 82293-012, 82293-013
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MYCOPHENOLATE SODIUM, MYCOPHENOLIC ACID
- RxCUI
- 485020, 485023, 616449, 616450
- SPL ID
- 47ef003d-aa2a-4b8e-9ab4-bba4cde21f09, 27fbf61b-de1e-479a-9d04-6dc1d48f3148, 255231b8-9564-4542-9449-9dcb8c8dd3e7, dd888996-35e0-4e02-af87-7557820412bc, 8617bd03-6da7-48ca-b430-6dfc38f19e2b, 471a0acf-310d-7b67-e063-6294a90adb0e, 52eeefe4-ea70-8fd7-e063-6294a90a6796, dd78e397-2a86-a739-d8f3-f01f37985a14, 69919e0a-ef1d-341e-32f9-4c907aaebe40, 98e5c815-0025-48c6-6ca1-76e2ae121258, 49ed1732-f2d8-4b03-8eb3-54748ad9b994, 1f0154d5-686f-170e-e063-6394a90a67e6
- SPL set ID
- a374549e-8afd-48fe-ae3f-368984689a2a, 2d9975e1-baee-4b0c-83de-8a0a92c5d075, 4b153bb3-fb7a-472d-b73e-e630e50c5633, eed26501-890d-4ff6-88e7-6dbea4726e53, 8617bd03-6da7-48ca-b430-6dfc38f19e2b, 30cb1078-929b-4c0f-be1d-49ef352dfab9, c1ce92ef-4102-1487-e053-2995a90ac521, 8516e135-5cc0-ef2d-6dad-0f9f841bb27b, c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0, 7f8d259a-9880-bb8b-2738-b3c6c1edf152, a2c1a135-67e7-4052-bbb9-b6135d45ff75, cbc3e916-09e2-4e6e-9e5e-98375f5e6d41
- Package NDC
- 68254-5001-1, 68254-5001-2, 68254-5002-1, 68254-5002-2, 67877-426-12, 67877-426-05, 67877-426-33, 67877-426-38, 67877-427-12, 67877-427-05, 67877-427-33, 67877-427-38, 85972-161-12, 85972-162-12, 0078-0386-66, 0078-0385-66, 67877-928-12, 67877-928-05, 67877-928-33, 67877-928-38, 67877-929-12, 67877-929-05, 67877-929-33, 67877-929-38, 72819-155-08, 72819-156-08, 70436-172-23, 70436-173-23, 70377-039-11, 70377-040-11, 60505-2965-3, 60505-2965-6, 60505-2965-9, 60505-2965-1, 60505-2965-7, 60505-2965-5, 60505-2965-8, 60505-2965-0, 60505-2966-3, 60505-2966-6 +12 more
- UNII
- WX877SQI1G, HU9DX48N0T
- Nui
- N0000175613
- Pharm class epc
- Antimetabolite Immunosuppressant [EPC]
- Drugcharacterization
- 1
- Medicinalproduct
- GEMTUZUMAB OZOGAMICIN
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- GEMTUZUMAB OZOGAMICIN
- Harmonized identifiers (openFDA)
- Application number
- BLA761060
- Brand name
- MYLOTARG
- Generic name
- GEMTUZUMAB OZOGAMICIN
- Manufacturer name
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Product NDC
- 0008-4510
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- GEMTUZUMAB OZOGAMICIN
- RxCUI
- 1944701, 1944704
- SPL ID
- ef242018-af2a-4c03-99b7-908e2610f86f
- SPL set ID
- 32fd2bb2-1cfa-4250-feb8-d7956c794e05
- Package NDC
- 0008-4510-01
- Nui
- N0000175571, N0000175077
- Pharm class epc
- CD33-directed Immunoconjugate [EPC]
- Pharm class moa
- CD33-directed Antibody Interactions [MoA]
- UNII
- 8GZG754X6M
- Drugcharacterization
- 1
- Medicinalproduct
- IDECABTAGENE VICLEUCEL
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- IDECABTAGENE VICLEUCEL
- Harmonized identifiers (openFDA)
- Application number
- BLA125736
- Brand name
- ABECMA
- Generic name
- IDECABTAGENE VICLEUCEL
- Manufacturer name
- Celgene Corporation
- Product NDC
- 59572-515
- Product type
- CELLULAR THERAPY
- Route
- INTRAVENOUS
- Substance name
- IDECABTAGENE VICLEUCEL
- RxCUI
- 2536434, 2536439, 2536443, 2536445, 2536449, 2536451
- SPL ID
- 4adbd9af-42bb-4e51-86fc-b06ccd213b43
- SPL set ID
- b90c1fe7-f5cc-464e-958a-af36e9c26d7c
- Package NDC
- 59572-515-01, 59572-515-02, 59572-515-03
- UNII
- 8PX1X7UG4D
- Drugcharacterization
- 1
- Medicinalproduct
- LAPATINIB
- Drugbatchnumb
- Not available
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- LAPATINIB
- Harmonized identifiers (openFDA)
- Application number
- ANDA217968, NDA022059, ANDA203007
- Brand name
- LAPATINIB, TYKERB
- Generic name
- LAPATINIB
- Manufacturer name
- Teva Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Lupin Pharmaceuticals, Inc.
- Product NDC
- 0480-3237, 0078-0671, 68180-801
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LAPATINIB DITOSYLATE
- RxCUI
- 672149, 672152
- SPL ID
- f259a366-78fc-4919-9bcb-748314a0581c, 940eccaf-92b4-4562-8579-24a53c1bc48d, d331d11d-21f4-472c-82d9-3b03b582026a
- SPL set ID
- b09abf73-1eef-4e12-b400-c030d546d223, eee37f88-ec6a-4c30-b8aa-e2c71f93088c, 50d0dd0c-7682-43d0-aa1b-ca26e9181aee
- Package NDC
- 0480-3237-51, 0078-0671-19, 68180-801-36
- UNII
- G873GX646R
- +55 more not shown