Seizure, Aspiration, Acute kidney injury +3
Drugs: METHOTREXATE, AZATHIOPRINE
- Safetyreportversion
- 1
- Safetyreportid
- 26940058
- Occurcountry
- BR
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 1
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 1
- Companynumb
- BR-AZURITY PHARMACEUTICALS, INC.-AZR202606-002438
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- E2B Report Duplicate
- Duplicatenumb
- AZR_AZR2606-00000226
- Primarysource
- Reportercountry
- CO
- Qualification
- 3
- Sender
- Sendertype
- 6
- Senderorganization
- AZURITY PHARMACEUTICALS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 45
- Patientonsetageunit
- 801
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Seizure
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Aspiration
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Acute kidney injury
- Reactionoutcome
- 5
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Metal poisoning
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Drug-induced liver injury
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Product use in unapproved indication
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- METHOTREXATE
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugrecurreadministration
- 3
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- METHOTREXATE
- Harmonized identifiers (openFDA)
- Application number
- ANDA210454, NDA011719, NDA212479, ANDA040385, ANDA040263, ANDA220225, ANDA040632, ANDA201529, ANDA201749, ANDA081235, NDA205776, NDA208400, ANDA040266, ANDA040843, ANDA207812, ANDA081099, ANDA040716, ANDA089343, ANDA089342, ANDA089341, ANDA089340, ANDA213343, ANDA217552, NDA204824
- Brand name
- METHOTREXATE, JYLAMVO, TREXALL, RASUVO, XATMEP, OTREXUP
- Generic name
- METHOTREXATE, METHOTREXATE SODIUM
- Manufacturer name
- Chartwell RX, LLC, Hospira, Inc., SHORLA ONCOLOGY INC., Teva Women's Health LLC, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals Inc., Hikma Pharmaceuticals USA Inc., Alembic Pharmaceuticals Limited, Eugia US LLC, Sun Pharmaceutical Industries, Inc., Mylan Pharmaceuticals Inc., Medexus Pharma Inc., Aurobindo Pharma Limited, Azurity Pharmaceuticals, Inc., Teva Parenteral Medicines, Inc., Zydus Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., Accord Healthcare, Inc., Zydus Lifesciences Limited, Accord Healthcare Inc., Antares Pharma, Inc.
- Product NDC
- 62135-772, 61703-350, 61703-408, 81927-204, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 62332-711, 62332-712, 0143-9830, 46708-711, 46708-712, 55150-510, 55150-511, 55150-512, 55150-513, 47335-235, 61703-124, 61703-161, 0378-0014, 0143-9367, 59137-505, 59137-510, 59137-515, 59137-520, 59137-525, 59137-530, 59137-535, 59137-540, 59137-550, 59651-182, 52652-2001, 63323-122, 0703-3671, 0703-3675, 0703-3678, 68382-775, 0555-0572 +17 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, INTRA-ARTERIAL
- Substance name
- METHOTREXATE SODIUM, METHOTREXATE
- RxCUI
- 105585, 1655956, 1946772, 2671456, 2671462, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, 1655959, 1655960, 1655967, 1655968, 1441416, 1544378, 1544383, 1544385, 1544386, 1544387, 1544388, 1544389, 1544390, 1544394, 1544395, 1544396, 1544397, 1544398, 1544401, 1544402, 1544403, 1544404, 1921592, 1921598, 1441402, 1441407 +13 more
- SPL ID
- 462a5023-e5a1-692a-e063-6294a90a7236, 95b8b8da-da4e-4bba-9038-3cf65f3d5c1a, 37b3e76b-ac3d-4f93-adf1-91f52f676b8a, 53bd9776-70ec-46f9-e063-6294a90a7011, d1e7432e-253d-49f0-ab0a-bb859210ccd6, 880c2caa-1b11-45ce-a54e-a3733da367f0, 91ce9c78-370f-49a1-ae22-428bdddb389f, 49eb25b2-c59c-4374-a216-076767fe1126, e98b2abd-8068-482e-9ce3-1ab262f0838e, adc6f7e8-b3a3-476a-9939-0c5cbda63dbd, 524f657e-d138-9c87-e063-6294a90a93ad, 6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910, 01ad6cb9-5879-4c06-801b-0de84eebaae7, 7950579c-084b-472b-a7ce-f342691aff97, 29d04017-dd64-4dea-a064-7b3b0805f423, 9fe03573-fff3-4051-8598-8542eee1273f, 4e3b0925-2cdc-4743-91cf-860d98dd4661, 3d21237a-ef53-4592-bf06-0c739696203d, e81074cc-12b4-4ac9-a5bb-749188989b2c, 5d9b7269-19d4-4d2c-b252-f3ff759dffa5, 9c7cf5a6-e720-4e83-bb08-f371e9bb9c9e, 5aa89975-d1a1-19f1-e063-6294a90a4b3e, 3046ff78-3565-46d1-a88b-283e5ff6e7c3, ae399908-cfb6-44dc-83da-8981f5dabbb8, 52d366f6-f339-ff1a-e063-6294a90a1577, 9dd138d6-6889-400e-a994-9931af68244a, 2d07eb50-d314-a6a0-e063-6394a90ac970, ff55c573-dc84-4ff3-9d10-2b24c47dd679
- SPL set ID
- 2609da8f-80dc-448e-8eba-35d11488ce7f, 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, 96e931f5-51ae-4bdf-a441-bb0dd26d4c0e, e942f8db-510f-44d6-acb5-b822196f5e8c, b585f621-f6c9-4735-ab61-bd1b401f3df0, a63364d5-4dfa-49d7-8a5e-c8959ae1d37a, b080eb92-fc72-4ce6-a7ab-3f9ce2415526, e98b2abd-8068-482e-9ce3-1ab262f0838e, 63bb6fbf-dd59-4edc-af8f-d0c397ca1262, 8f1260de-b60c-4f0e-8af6-0e957b0a281b, bd287e89-32f9-4396-95fa-4b562869f476, 70c09984-2b36-424f-8b27-3fd0cd4e833d, 8593f7fc-eabe-44ae-bb05-b3d7d408e4f7, d0075461-0e7e-4967-9c9b-d6440e912c0e, 09931d44-a3f8-49dc-a3f2-b527ee4214bf, aec9984e-34c5-481b-b6bf-9bb5caf1daf8, ec476b11-0b3c-4139-b1eb-a3daa76bc271, 346ec9ce-dc98-4a55-b55e-d3af11f2d703, 948e0bab-6524-4b87-9853-1799d4415558, 9b34b1d8-d125-41a2-9f6f-3fab67b573bd, dd035a9f-cd40-4314-b9d8-2294b8a924e2, 3989d30d-56e5-4e8d-9379-c30fecc894f2, 59ea7b32-2b6d-4197-92c3-015936f04ebe, 874c7f43-a3be-4236-89cc-24c44e3c5813, 04a95db9-a124-4b97-bd71-1c37a6b3b0c8, 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5, ff55c573-dc84-4ff3-9d10-2b24c47dd679
- Package NDC
- 62135-772-35, 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408-25, 81927-204-01, 51285-366-01, 51285-367-01, 51285-368-01, 51285-369-01, 63323-123-10, 62332-711-01, 62332-711-05, 62332-712-01, 0143-9830-01, 46708-711-01, 46708-711-05, 46708-712-01, 55150-510-01, 55150-510-05, 55150-511-01, 55150-511-10, 55150-512-01, 55150-512-10, 55150-513-01, 47335-235-96, 47335-235-83, 61703-124-40, 61703-161-02, 61703-161-05, 0378-0014-01, 0143-9367-01, 59137-505-00, 59137-505-01, 59137-505-04, 59137-510-00, 59137-510-01, 59137-510-04 +88 more
- UNII
- 3IG1E710ZN, YL5FZ2Y5U1
- Nui
- N0000175584, N0000000111
- Pharm class epc
- Folate Analog Metabolic Inhibitor [EPC]
- Pharm class moa
- Folic Acid Metabolism Inhibitors [MoA]
- Drugcharacterization
- 1
- Medicinalproduct
- AZATHIOPRINE
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Rheumatoid arthritis
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- AZATHIOPRINE
- Harmonized identifiers (openFDA)
- Application number
- ANDA074069, ANDA075252, ANDA077621, ANDA075568, NDA016324, ANDA208687
- Brand name
- AZATHIOPRINE, AZASAN, IMURAN
- Generic name
- AZATHIOPRINE
- Manufacturer name
- AvKARE, Salix Pharmaceuticals, Amneal Pharmaceuticals NY LLC, Oceanside Pharmaceuticals, Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Rising Pharma Holdings, Inc., Sebela Pharmaceuticals Inc., Ascend Laboratories, LLC
- Product NDC
- 42291-071, 65649-231, 65649-241, 69238-1076, 68682-231, 68682-241, 65841-602, 68382-003, 68382-118, 68382-119, 68382-120, 16571-835, 54766-590, 67877-492, 67877-493, 67877-494, 67877-495, 70771-1139, 70771-1140, 70771-1141
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- AZATHIOPRINE
- RxCUI
- 197388, 359228, 359229, 404475, 404476, 199310, 105611
- SPL ID
- 485b4c20-1aec-8ffd-e063-6294a90a104f, 85aaaf8a-26bf-4878-9356-490f17fe65ef, d4549001-c251-4461-b3ff-5d25e9243918, 72e365c2-ab18-4c84-8252-d5287ceeb95f, b1337f9b-c728-4b49-b29a-4f593c100f9c, 64e1751f-fdf5-45e7-ac57-6499c0b5aa91, 99588075-8b4a-45ec-90ca-2a23fdd8262a, 431426e8-80d4-a4e2-e063-6394a90af918, 7fdec2f6-c3b5-483f-8bfc-0afb292781da, 1277f50f-59f8-4c65-88de-011424884c3b
- SPL set ID
- d4c7d621-9642-4027-e053-2995a90a9220, 9050af7a-19c6-4670-937a-9445605de995, c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c, d72ede2c-1a9b-4717-80a7-b76a6a499936, d65bc662-2ae8-4ddb-acc8-f616e72e6140, b1b0fa3e-11c3-46d0-9537-6b372c2a1b56, 2ffa2fce-895d-469e-8667-b078560aec5f, 606101a0-6244-7eff-e053-2a91aa0acadd, bc6dc4bd-2121-4613-9d90-4a504010c98a, 89b272f0-ef5c-49e4-820f-fcd7ea8ef066
- Package NDC
- 42291-071-01, 65649-231-41, 65649-241-41, 69238-1076-1, 68682-231-01, 68682-241-01, 65841-602-01, 65841-602-05, 68382-003-01, 68382-003-05, 68382-118-01, 68382-118-05, 68382-119-01, 68382-119-05, 68382-120-01, 68382-120-05, 16571-835-01, 54766-590-10, 67877-492-01, 67877-492-05, 67877-492-10, 67877-492-14, 67877-492-33, 67877-492-38, 67877-493-01, 67877-493-05, 67877-493-10, 67877-493-33, 67877-493-38, 67877-494-01, 67877-494-05, 67877-494-10, 67877-494-33, 67877-494-38, 67877-495-01, 67877-495-05, 67877-495-10, 67877-495-33, 67877-495-38, 70771-1139-1 +5 more
- Nui
- N0000000233, M0015066, N0000175712, M0018169
- Pharm class moa
- Nucleic Acid Synthesis Inhibitors [MoA]
- Pharm class cs
- Nucleosides [CS], Purines [CS]
- Pharm class epc
- Purine Antimetabolite [EPC]
- UNII
- MRK240IY2L