Memory impairment, Off label use
Drugs: ALPHAGAN P, OFEV, TRYPTYR +4
- Safetyreportversion
- 1
- Safetyreportid
- 27325195
- 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-ABBVIE-6948507
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- ABBVIE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 84
- Patientonsetageunit
- 801
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Memory impairment
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Off label use
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- ALPHAGAN P
- Drugbatchnumb
- NOT AVAILABLE
- Drugauthorizationnumb
- 021262
- Drugseparatedosagenumb
- 1
- Drugadministrationroute
- 047
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- BRIMONIDINE TARTRATE
- Harmonized identifiers (openFDA)
- Application number
- NDA021262, NDA021770
- Brand name
- ALPHAGAN P
- Generic name
- BRIMONIDINE TARTRATE
- Manufacturer name
- Allergan, Inc.
- Product NDC
- 0023-9177, 0023-9321
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Substance name
- BRIMONIDINE TARTRATE
- RxCUI
- 861204, 861206, 861208, 861210
- SPL ID
- d93b4518-c444-4a54-ba55-1fbfc7542911
- SPL set ID
- 264c4494-c225-486f-888a-caaf36be46b3
- Package NDC
- 0023-9321-03, 0023-9321-05, 0023-9321-10, 0023-9321-15, 0023-9177-05, 0023-9177-10, 0023-9177-15
- UNII
- 4S9CL2DY2H
- Drugcharacterization
- 1
- Medicinalproduct
- OFEV
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- NINTEDANIB
- Harmonized identifiers (openFDA)
- Application number
- NDA205832
- Brand name
- OFEV
- Generic name
- NINTEDANIB
- Manufacturer name
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product NDC
- 0597-0143, 0597-0145
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- NINTEDANIB ESYLATE
- RxCUI
- 1592742, 1592748, 1592750, 1592752
- SPL ID
- 5c860918-0d7e-4aaf-b103-85f66e9dcdbe
- SPL set ID
- da1c9f37-779e-4682-816f-93d0faa4cfc9
- Package NDC
- 0597-0145-60, 0597-0143-60
- UNII
- 42F62RTZ4G
- Drugcharacterization
- 1
- Medicinalproduct
- TRYPTYR
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 0.5
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 0.003?INSTILL 1 DROP INTO BOTH EYES TWICE A DAY
- Drugdosageform
- Eye drops
- Drugadministrationroute
- 047
- Drugindication
- Glaucoma
- Drugstartdateformat
- 102
- Drugstartdate
- 20260204
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- ACOLTREMON
- Harmonized identifiers (openFDA)
- Application number
- NDA217370
- Brand name
- TRYPTYR
- Generic name
- ACOLTREMON
- Manufacturer name
- Alcon Laboratories, Inc.
- Product NDC
- 0065-8595
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC, TOPICAL
- Substance name
- ACOLTREMON
- RxCUI
- 2716821, 2716826
- SPL ID
- 27fdd84a-2d62-4c79-afb0-5d5bd608fdfc
- SPL set ID
- 2b7715a1-035c-4002-b582-5238efee5d58
- Package NDC
- 0065-8595-01, 0065-8595-02
- Nui
- N0000194172, N0000194173
- Pharm class epc
- TRPM8 Thermoreceptor Agonist [EPC]
- Pharm class moa
- TRPM8 Thermoreceptor Agonists [MoA]
- UNII
- 1L7BVT4Z4Z
- Drugcharacterization
- 1
- Medicinalproduct
- EVENITY
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- ROMOSOZUMAB-AQQG
- Harmonized identifiers (openFDA)
- Application number
- BLA761062
- Brand name
- EVENITY
- Generic name
- ROMOSOZUMAB-AQQG
- Manufacturer name
- Amgen, Inc
- Product NDC
- 55513-509, 55513-880, 55513-998
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- ROMOSOZUMAB
- RxCUI
- 2123184, 2123185, 2123190, 2123191
- SPL ID
- 1b60403e-86c5-4694-8cb5-2fc19f46dc49
- SPL set ID
- 471baba2-7154-4488-9891-0db2f46791e7
- Package NDC
- 55513-880-01, 55513-880-02, 55513-998-01, 55513-998-02, 55513-509-01, 55513-509-02
- UNII
- 3VHF2ZD92J
- Drugcharacterization
- 1
- Medicinalproduct
- LUMIGAN
- Drugbatchnumb
- Not available
- Drugauthorizationnumb
- 022184
- Drugseparatedosagenumb
- 1
- Drugadministrationroute
- 047
- Drugindication
- Product used for unknown indication
- Actiondrug
- 5
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- BIMATOPROST
- Harmonized identifiers (openFDA)
- Application number
- NDA022184
- Brand name
- LUMIGAN
- Generic name
- BIMATOPROST
- Manufacturer name
- Allergan, Inc.
- Product NDC
- 0023-3205
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Substance name
- BIMATOPROST
- RxCUI
- 1009339, 1009341
- SPL ID
- 39a1b7fa-9866-4b23-a97e-5dc3e663ad4a
- SPL set ID
- a5e67c75-db88-4372-bb07-c8dd15c97631
- Package NDC
- 0023-3205-02, 0023-3205-03, 0023-3205-05, 0023-3205-08
- Nui
- N0000175454, M0017805
- Pharm class epc
- Prostaglandin Analog [EPC]
- Pharm class cs
- Prostaglandins [CS]
- UNII
- QXS94885MZ
- Drugcharacterization
- 2
- Medicinalproduct
- IRON
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- IRON
- Harmonized identifiers (openFDA)
- Brand name
- FERRUM METALLICUM 6X, FERRUM METALLICUM, REAL SUMMER
- Generic name
- IRON
- Manufacturer name
- True Botanica, LLC, Boiron, KAYONE
- Product NDC
- 53645-1472, 0220-2055, 0220-2085, 69449-1010, 0220-2051, 0220-2050, 0220-2047, 0220-2046, 0220-2054
- Product type
- HUMAN OTC DRUG
- Route
- ORAL, TOPICAL
- Substance name
- IRON
- SPL ID
- 23927d2e-da68-f2b5-e063-6394a90a3b8a, 0a0ce402-1803-62f2-e063-6294a90a9770, 0a0ce624-1a00-85f4-e063-6294a90ac29a, 28d3becf-e4b9-4bcf-e063-6294a90a1327, f6002c71-2a53-b17b-e053-2995a90a0576, 0a0ce624-19fe-85f4-e063-6294a90ac29a, 0a0cdff5-2760-8938-e063-6294a90ad4fb, 0a0ce402-1802-62f2-e063-6294a90a9770, f5294c54-6706-bc8d-e053-2a95a90a5567
- SPL set ID
- 2392929c-996b-01e0-e063-6394a90aa2b9, 8591b12c-51c8-9839-e053-2a91aa0aa937, 87372ec7-eacf-90b1-e053-2a91aa0afadf, 63021d49-8720-4e4e-a08f-a5d2f6acfaa5, 859195ed-0b6c-f4fe-e053-2991aa0ad85b, 85917340-1f94-08db-e053-2a91aa0a77c9, 85914cb4-f903-80c6-e053-2a91aa0ae14a, 85912948-19cc-76be-e053-2991aa0a3e5a, 85919b82-39cf-254d-e053-2a91aa0a6150
- Package NDC
- 53645-1472-6, 0220-2055-41, 0220-2085-41, 69449-1010-1, 0220-2051-41, 0220-2050-41, 0220-2047-41, 0220-2046-41, 0220-2054-41
- UNII
- E1UOL152H7
- Drugcharacterization
- 2
- Medicinalproduct
- PREDNISONE
- Drugseparatedosagenumb
- 1
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- PREDNISONE
- Harmonized identifiers (openFDA)
- Application number
- ANDA215246, ANDA040584, ANDA040581, ANDA040256, ANDA040392, ANDA210785, ANDA218035, ANDA080352, ANDA211495, ANDA215671, ANDA219477, ANDA088703, ANDA084275, ANDA208412, ANDA211496, ANDA213385, ANDA215672, ANDA212629, ANDA213386, ANDA211575, ANDA080356, ANDA085162, ANDA085161
- Brand name
- PREDNISONE, PREDNISONE DELAYED RELEASE, PREDNISONE TABLETS, USP, 5 MG, PREDNISONE TABLETS, USP, 10 MG, PREDNISONE TABLETS, USP, 20 MG
- Generic name
- PREDNISONE
- Manufacturer name
- ANI Pharmaceuticals, Inc., Par Health USA, LLC, Strides Pharma Science Limited, Dr. Reddys Laboratories Inc., Hikma Pharmaceuticals USA Inc., Chartwell RX, LLC, Aurobindo Pharma Limited, INA Pharmaceutics Inc, Amneal Pharmaceuticals NY LLC, Granulation Technology, Inc., Actavis Pharma, Inc.
- Product NDC
- 70954-056, 0603-5335, 0603-5336, 0603-5337, 0603-5338, 0603-5339, 64380-782, 43598-888, 0054-9817, 0054-9828, 0054-9818, 62135-471, 59651-484, 74157-010, 74157-019, 0054-0017, 0054-4741, 0054-4742, 0054-4728, 0054-0018, 0054-0019, 0054-3722, 0054-3721, 0054-8739, 0054-8740, 0054-8724, 62135-553, 64380-783, 64380-835, 62135-470, 60219-1705, 60219-1706, 59651-485, 59651-486, 59651-487, 59651-488, 59651-489, 64380-784, 64380-785, 64380-949 +13 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- PREDNISONE
- RxCUI
- 198144, 198145, 198146, 312615, 312617, 763179, 763181, 763183, 763185, 1303135, 1303125, 1303132, 198148, 205301, 315187
- SPL ID
- 08d9d724-eebf-4785-a0ac-95c049bc9488, 68bdeba1-553d-4d18-ae66-5eb8a0a880b8, 675efef2-fa13-42d1-9460-d1e334f78a48, 1da2eb36-ff47-3cf6-e845-67460ced05fb, 249c4c6d-a058-489a-8f84-928c14bfd3f9, 45ae68aa-b969-3d1b-e063-6394a90a0a02, 6f9a9020-efd5-4f7d-90c7-11af33e93793, 463c5b39-7eb2-d396-e063-6394a90aa451, 523ad364-8d95-4679-9290-446d61f36eb5, 04b754a5-5740-f71c-e063-6294a90aef67, c389b525-c68a-43dc-bacc-c75707b391b5, 45ae6dea-506e-55d8-e063-6394a90a0a4c, abdf7308-9460-4e7f-a68a-2fe647e82602, d957f055-4838-49e6-ae32-604fb3056bc4, bdf0b63b-7d6e-4799-be31-cdbf94e02145, 3c696af0-7946-dd78-e063-6394a90a71cc, 34381f6f-1b15-42c8-a8e6-af8302eb6c1e, f662b658-7133-468c-b35a-ed6083cbff91, 6e6cf2e7-c839-4c9f-a58a-fea5023fb432
- SPL set ID
- 7335a293-992b-490c-ab8a-66a7ca1eea30, 10fe5a3b-84dc-4600-87c2-b80c97ce18cf, a2c2e8ee-d222-47c5-93c2-8b44160a7e48, 474974ac-9811-c9f5-4050-58e535351d00, 263ed4fa-3c29-4abb-9cb1-bc016bd34a05, 36631112-3abb-4003-886b-9fe6d9cbe2cc, 7b33767f-a520-4470-8f3f-4e86b38d615a, 463c7cd2-c973-5c6c-e063-6394a90a09a0, 3115aef0-fd50-4ec8-a064-3effb695f3f2, 92483276-d55c-42c6-8bbc-27137ff25296, 52010a34-aadb-4561-ac4a-3ee53f5e3566, f532c919-765d-407a-9e01-db2dc0c006f5, 0740ef68-7641-432e-bd46-4710687fc9d7, b1ac4c92-e1fd-4015-b172-0932790ae019, 2ef05381-faad-4e0f-b58d-9f2236a04a2c, a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f, 03228706-92b9-43c9-8d73-c73aa124c58d, f05eb734-07e7-491c-b2e9-aae340e03750, aa0b1582-6ef3-4697-9ea6-5391e6e57853
- Package NDC
- 70954-056-10, 70954-056-20, 0603-5335-21, 0603-5335-32, 0603-5336-21, 0603-5337-21, 0603-5337-32, 0603-5337-15, 0603-5337-31, 0603-5338-21, 0603-5338-28, 0603-5338-32, 0603-5338-15, 0603-5338-31, 0603-5339-21, 0603-5339-28, 0603-5339-32, 64380-782-06, 43598-888-01, 43598-888-30, 0054-9828-25, 0054-9828-31, 0054-9817-25, 0054-9817-29, 0054-9818-25, 0054-9818-29, 62135-471-90, 62135-471-18, 59651-484-01, 59651-484-99, 59651-484-78, 74157-010-30, 74157-019-30, 0054-4741-25, 0054-4741-31, 0054-4742-25, 0054-4728-25, 0054-4728-31, 0054-0017-25, 0054-0017-29 +89 more
- Nui
- N0000175576, N0000175450
- Pharm class epc
- Corticosteroid [EPC]
- Pharm class moa
- Corticosteroid Hormone Receptor Agonists [MoA]
- UNII
- VB0R961HZT
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260101