Pancytopenia, Aphthous ulcer, Interstitial lung disease
Drugs: PANTOPRAZOLE, METHOTREXATE SODIUM
- Safetyreportversion
- 1
- Safetyreportid
- 27325196
- Primarysourcecountry
- EU
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Authoritynumb
- EU-AFSSAPS-BS2026000499
- Primarysource
- Reportercountry
- EU
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- TEVA PHARMACEUTICALS INDUSTRIES LTD.
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 63
- Patientonsetageunit
- 801
- Patientweight
- 55
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pancytopenia
- Reactionoutcome
- 1
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Aphthous ulcer
- Reactionoutcome
- 1
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Interstitial lung disease
- Reactionoutcome
- 1
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- PANTOPRAZOLE
- Drugauthorizationnumb
- 077056
- Drugstructuredosagenumb
- 40
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugindication
- Product used for unknown indication
- Drugtreatmentduration
- 400
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 4
- Drugrecurreadministration
- 3
- Activesubstance
- Activesubstancename
- PANTOPRAZOLE
- Harmonized identifiers (openFDA)
- Application number
- ANDA202882, ANDA205119, ANDA077619
- Brand name
- PANTOPRAZOLE SODIUM, PANTOPRAZOLE
- Generic name
- PANTOPRAZOLE
- Manufacturer name
- XLCare Pharmaceuticals Inc., Quallent Pharmaceuticals Health LLC, Amneal Pharmaceuticals LLC, Camber Pharmaceuticals, Inc., NorthStar RxLLC, Dr.Reddy's Laboratories Limited
- Product NDC
- 72865-229, 72865-230, 82009-010, 82009-011, 65162-636, 65162-637, 31722-712, 31722-713, 72603-177, 72603-178, 55111-332, 55111-333
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- PANTOPRAZOLE SODIUM
- RxCUI
- 251872, 314200
- SPL ID
- f26fc428-a419-1008-e053-2a95a90a83fc, 48430767-cec0-15e0-e063-6394a90ac032, 940df77d-5373-4196-946e-19271ac91087, 48f42a12-2eac-e5dd-e063-6294a90aa92d, 57338853-6995-de1e-62ca-be5505c8d656, c0575fc6-20c4-12a6-10b7-1af65cac1ee0
- SPL set ID
- 17468dbf-84b6-4c53-9ad5-341350d2cfab, 643eb498-d916-4fb7-9281-32895575ab36, f3ded82a-cf0d-4844-944a-75f9f9215ff0, 9daa1483-5a36-44db-9e0d-904d100da262, 82f0103a-2b97-d210-6d7d-c627d60ad694, 564709e8-358f-c185-4ecb-b3849c3fe59c
- Package NDC
- 72865-229-90, 72865-230-90, 72865-230-10, 82009-010-90, 82009-011-90, 82009-011-10, 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-50, 65162-637-11, 31722-712-90, 31722-712-32, 31722-712-31, 31722-713-90, 31722-713-32, 31722-713-31, 31722-713-10, 72603-177-01, 72603-178-01, 55111-332-30, 55111-332-90, 55111-332-01, 55111-332-05, 55111-332-10, 55111-332-79, 55111-332-81, 55111-332-78, 55111-333-30, 55111-333-90, 55111-333-01, 55111-333-05, 55111-333-10, 55111-333-79, 55111-333-81, 55111-333-78
- UNII
- 6871619Q5X
- Drugcharacterization
- 1
- Medicinalproduct
- METHOTREXATE SODIUM
- Drugstructuredosagenumb
- 15
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 803
- Drugindication
- Polymyalgia rheumatica
- Drugstartdateformat
- 102
- Drugstartdate
- 20241215
- Drugenddateformat
- 102
- Drugenddate
- 20250315
- Drugtreatmentduration
- 90
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- METHOTREXATE SODIUM
- Harmonized identifiers (openFDA)
- Application number
- ANDA040263, ANDA201749, ANDA040266, ANDA216453, ANDA040054
- Brand name
- METHOTREXATE, METHOTREXATE SODIUM
- Generic name
- METHOTREXATE SODIUM
- Manufacturer name
- Fresenius Kabi USA, LLC, Sun Pharmaceutical Industries, Inc., Elite Laboratories, Inc., Hikma Pharmaceuticals USA Inc.
- Product NDC
- 63323-123, 47335-235, 63323-122, 64850-330, 0054-4550, 0054-8550
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL
- Substance name
- METHOTREXATE SODIUM
- RxCUI
- 1946772, 105585, 311625
- SPL ID
- 880c2caa-1b11-45ce-a54e-a3733da367f0, 524f657e-d138-9c87-e063-6294a90a93ad, 3d21237a-ef53-4592-bf06-0c739696203d, 030a6bcf-d482-4c98-9d27-423235cdb930, 09f7cdcb-241e-4916-a68c-b4c452d3d640
- SPL set ID
- b585f621-f6c9-4735-ab61-bd1b401f3df0, 8f1260de-b60c-4f0e-8af6-0e957b0a281b, ec476b11-0b3c-4139-b1eb-a3daa76bc271, 89c05ea3-3be1-46dd-b112-29c436fd7289, d71b1856-99d8-4a9e-9189-f87b6675f80a
- Package NDC
- 63323-123-10, 47335-235-96, 47335-235-83, 63323-122-50, 64850-330-01, 0054-4550-25, 0054-4550-15, 0054-8550-25
- UNII
- 3IG1E710ZN
- Drugcharacterization
- 1
- Medicinalproduct
- METHOTREXATE SODIUM
- Drugstructuredosagenumb
- 17.5
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 803
- Drugstartdateformat
- 102
- Drugstartdate
- 20250316
- Drugenddateformat
- 102
- Drugenddate
- 20260420
- Drugtreatmentduration
- 400
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- METHOTREXATE SODIUM
- Harmonized identifiers (openFDA)
- Application number
- ANDA040263, ANDA201749, ANDA040266, ANDA216453, ANDA040054
- Brand name
- METHOTREXATE, METHOTREXATE SODIUM
- Generic name
- METHOTREXATE SODIUM
- Manufacturer name
- Fresenius Kabi USA, LLC, Sun Pharmaceutical Industries, Inc., Elite Laboratories, Inc., Hikma Pharmaceuticals USA Inc.
- Product NDC
- 63323-123, 47335-235, 63323-122, 64850-330, 0054-4550, 0054-8550
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL
- Substance name
- METHOTREXATE SODIUM
- RxCUI
- 1946772, 105585, 311625
- SPL ID
- 880c2caa-1b11-45ce-a54e-a3733da367f0, 524f657e-d138-9c87-e063-6294a90a93ad, 3d21237a-ef53-4592-bf06-0c739696203d, 030a6bcf-d482-4c98-9d27-423235cdb930, 09f7cdcb-241e-4916-a68c-b4c452d3d640
- SPL set ID
- b585f621-f6c9-4735-ab61-bd1b401f3df0, 8f1260de-b60c-4f0e-8af6-0e957b0a281b, ec476b11-0b3c-4139-b1eb-a3daa76bc271, 89c05ea3-3be1-46dd-b112-29c436fd7289, d71b1856-99d8-4a9e-9189-f87b6675f80a
- Package NDC
- 63323-123-10, 47335-235-96, 47335-235-83, 63323-122-50, 64850-330-01, 0054-4550-25, 0054-4550-15, 0054-8550-25
- UNII
- 3IG1E710ZN
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260201