Urticaria, Rash
Drugs: DUPIXENT, SPIRONOLACTONE
- Safetyreportversion
- 1
- Safetyreportid
- 27325238
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-SA-2026SA0221328
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- SANOFI AVENTIS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Patientweight
- 45.359
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Urticaria
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Rash
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugbatchnumb
- 5F871A
- Drugauthorizationnumb
- 761055
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 2
- Drugintervaldosagedefinition
- 803
- Drugdosagetext
- 300.000MG QOW
- Drugindication
- Idiopathic urticaria
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugauthorizationnumb
- 761055
- Drugindication
- Dermatitis atopic
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugauthorizationnumb
- 761055
- Drugindication
- Urticaria
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Drugcharacterization
- 2
- Medicinalproduct
- SPIRONOLACTONE
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- SPIRONOLACTONE
- Harmonized identifiers (openFDA)
- Application number
- ANDA091426, ANDA040750, ANDA203253, ANDA203512, NDA209478, ANDA219494, ANDA202187, ANDA218085, ANDA215572, ANDA205936, ANDA217761, NDA012151, ANDA089424, ANDA040424
- Brand name
- SPIRONOLACTONE, ALDACTONE
- Generic name
- SPIRONOLACTONE
- Manufacturer name
- Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Jubilant Cadista Pharmacuticals Inc., Accord Healthcare, Inc., Amneal Pharmaceuticals of New York LLC, Padagis US LLC, Rising Pharma Holdings, Inc., NorthStar Rx LLC, Camber Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Zydus Lifesciences Limited, Pfizer Laboratories Div Pfizer Inc, Zydus Pharmaceuticals (USA) Inc., Sun Pharmaceutical Industries, Inc., Mylan Pharmaceuticals Inc.
- Product NDC
- 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 59746-216, 59746-217, 59746-218, 16729-225, 16729-226, 16729-227, 53746-511, 53746-514, 53746-515, 0574-1133, 64980-706, 64980-707, 64980-708, 72603-134, 72603-135, 72603-136, 31722-691, 69238-2027, 70771-1027, 70771-1028, 70771-1029, 31722-094, 31722-095, 31722-096, 0025-1001, 0025-1041, 0025-1031, 68382-660, 68382-661, 68382-662, 53489-143, 53489-328, 53489-329, 0378-0243 +2 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- SPIRONOLACTONE
- RxCUI
- 198222, 198223, 313096, 104232, 200817, 200820, 200825
- SPL ID
- 8cdb3181-3666-48aa-a197-fb3a1e082e74, 70be7336-8f41-4960-b57d-7830ca020481, c1c5fdab-3ff7-414b-8e25-beed8311b8ad, 44e7bdd1-ae77-4b63-e063-6294a90a2c28, 0b757d66-e1f0-4d56-bbe0-2f0941f0a35e, 902035fb-dba8-4fdf-9d8d-29d736c07d57, 1db052c9-3239-4b01-977e-99e9c58962f2, 7839b797-5078-4aab-93a5-6056e4b9cdd5, 04da3e98-02e5-4d5a-94b2-9a6f74c44f15, 3241a29b-82b9-fd3a-e063-6294a90aa46c, e25b36dd-7948-4481-8994-13658f1f337f, 038310cc-d190-4868-9442-00f7222d0597, 55b4deef-e478-6648-e063-6294a90ae730, 22946678-dcad-4518-9bc6-cbdf51a38c16, 79b8df9c-5a73-432e-bd16-bbbecd9e2046, 57e3eb73-8cac-c76d-e063-6394a90a5962, b78b6da0-ce99-4c8f-bf36-c4e19b34dfd9
- SPL set ID
- fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, c1c5fdab-3ff7-414b-8e25-beed8311b8ad, 8a96e2c9-049a-43ab-abf3-21baedeb736f, 951b8948-dc0f-4aef-9910-82c252de936d, 522bd365-ddcc-48f4-8a98-66dc4c3bb314, ac487ae2-e15f-4781-bae3-a03058cfcfe4, a7510768-8a52-4230-6aa0-b0d92d82588f, ae0dcb4e-63df-459c-8e60-0caa817b8135, 4ac2926a-949a-4383-b0b0-92c0822dfcda, 1ed9a2cb-d666-43db-b515-f9615fa6da25, 963af399-feb7-49d2-a59c-c19edad9c682, e61269b2-823a-49e8-b55f-ef0b8b1dbcde, 0fed2822-3a03-4b64-9857-c682fcd462bc, 99bbc053-0e41-4b4d-979a-db610908f2de, c23b6b9b-aec3-48a8-a518-76e4097f6479, beaf74db-4159-3b59-ef99-575c3ac99aa1
- Package NDC
- 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511-50, 65162-511-60, 65162-514-03, 65162-514-06, 65162-514-09, 65162-514-10, 65162-514-11, 65162-514-50, 65162-514-60, 65162-515-03, 65162-515-06, 65162-515-09, 65162-515-10, 65162-515-11, 65162-515-50, 65162-515-60, 69584-852-09, 69584-852-10, 69584-852-50, 69584-852-90, 69584-852-92, 69584-853-09, 69584-853-10, 69584-853-50, 69584-853-90, 69584-854-09, 69584-854-10, 69584-854-50, 69584-854-90, 59746-216-06, 59746-216-09, 59746-216-15, 59746-217-06, 59746-217-09, 59746-218-06 +128 more
- Nui
- N0000175557, N0000011310
- Pharm class epc
- Aldosterone Antagonist [EPC]
- Pharm class moa
- Aldosterone Antagonists [MoA]
- UNII
- 27O7W4T232