Mucous membrane pemphigoid, Blindness, Corneal neovascularisation +2
Drugs: SITAGLIPTIN, METFORMIN, ACARBOSE +3
- Safetyreportversion
- 1
- Safetyreportid
- 27325226
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 1
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- EU-APCER Life Sciences-Azurity-2026-02148
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- APCER Life Sciences
- Duplicatenumb
- EU-APCER Life Sciences-Azurity-2026-02148
- Primarysource
- Reportercountry
- CO
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- AZURITY PHARMACEUTICALS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 61
- Patientonsetageunit
- 801
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Mucous membrane pemphigoid
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Blindness
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Corneal neovascularisation
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Endophthalmitis
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Iris adhesions
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- SITAGLIPTIN
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Type 2 diabetes mellitus
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Activesubstance
- Activesubstancename
- SITAGLIPTIN
- Harmonized identifiers (openFDA)
- Application number
- ANDA202327, NDA211566, NDA021995
- Brand name
- SITAGLIPTIN, JANUVIA, ZITUVIO
- Generic name
- SITAGLIPTIN
- Manufacturer name
- Teva Pharmaceuticals, Inc., Zydus Lifesciences Limited, Zydus Pharmaceuticals (USA) Inc., Merck Sharp & Dohme LLC
- Product NDC
- 0480-2607, 0480-2608, 0480-2609, 70771-1790, 70771-1791, 70771-1792, 70710-1899, 70710-1900, 70710-1901, 0006-0112, 0006-0221, 0006-0277, 70710-1240, 70710-1241, 70710-1242, 70771-1770, 70771-1771, 70771-1772
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- SITAGLIPTIN PHOSPHATE, SITAGLIPTIN
- RxCUI
- 2709603, 2709608, 2709612, 665033, 665038, 665042, 665036, 665040, 665044, 2670447, 2670449, 2670451
- SPL ID
- ab518e96-e35b-40b1-b7e8-b4e01ada32eb, f5e22251-a49c-409a-8687-a15b20c13906, c489d9fa-c7f0-473f-9f7b-77086e137e8f, 71d449de-955b-4711-9a44-1e1f66e2e9eb, 1686e1de-8172-444b-a267-ad3bc7ca69f1, 938530d0-f5ca-451d-a8d4-55384ae75e20
- SPL set ID
- 5fa5aa67-455e-4ac6-864d-268a91286432, e5ac97e8-3a0b-4750-8e3f-337412570746, 6a970e80-b753-48fa-9fff-87e7a5044982, f85a48d0-0407-4c50-b0fa-7673a160bf01, abfdea45-c0ca-41e3-a510-e89810bc9cfe, b2da9d77-154b-48f7-8793-3f4a24dfafc6
- Package NDC
- 0480-2607-56, 0480-2607-98, 0480-2608-56, 0480-2608-98, 0480-2609-56, 0480-2609-98, 0480-2609-10, 70771-1790-3, 70771-1790-9, 70771-1791-3, 70771-1791-9, 70771-1792-3, 70771-1792-9, 70710-1899-3, 70710-1899-9, 70710-1900-3, 70710-1900-9, 70710-1901-3, 70710-1901-9, 0006-0221-01, 0006-0221-28, 0006-0221-31, 0006-0221-54, 0006-0112-01, 0006-0112-28, 0006-0112-31, 0006-0112-54, 0006-0277-01, 0006-0277-28, 0006-0277-31, 0006-0277-54, 0006-0277-02, 0006-0277-33, 0006-0277-82, 0006-0277-14, 0006-0277-27, 0006-0277-30, 70710-1240-9, 70710-1240-3, 70710-1241-3 +9 more
- UNII
- TS63EW8X6F, QFP0P1DV7Z
- Nui
- N0000175913, N0000175912
- Pharm class epc
- Dipeptidyl Peptidase 4 Inhibitor [EPC]
- Pharm class moa
- Dipeptidyl Peptidase 4 Inhibitors [MoA]
- Drugcharacterization
- 2
- Medicinalproduct
- METFORMIN
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- METFORMIN HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA209674, ANDA209313
- Brand name
- METFORMIN
- Generic name
- METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG
- Manufacturer name
- Ingenus Pharmaceuticals, LLC, Granules Pharmaceuticals Inc.
- Product NDC
- 50742-633, 50742-634, 70010-491, 70010-492
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- METFORMIN HYDROCHLORIDE
- RxCUI
- 1807894, 1807917, 860975, 860981
- SPL ID
- 3a97a225-ff03-4d81-a2fe-7f66611cc4c1, 537f5fd2-89a1-d029-e063-6394a90a9d0e
- SPL set ID
- 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6ee6f8-9650-ff4f-e053-2991aa0acf19
- Package NDC
- 50742-633-60, 50742-633-90, 50742-633-10, 50742-634-30, 50742-634-60, 50742-634-10, 70010-491-01, 70010-491-05, 70010-491-10, 70010-491-18, 70010-491-19, 70010-491-09, 70010-492-01, 70010-492-05, 70010-492-20, 70010-492-21
- UNII
- 786Z46389E
- Drugcharacterization
- 2
- Medicinalproduct
- ACARBOSE
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- ACARBOSE
- Harmonized identifiers (openFDA)
- Application number
- ANDA202271, ANDA090912, ANDA078470
- Brand name
- ACARBOSE
- Generic name
- ACARBOSE
- Manufacturer name
- Chartwell RX, LLC, Strides Pharma Science Limited, Hikma Pharmaceuticals USA Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Product NDC
- 62135-453, 62135-454, 62135-455, 64380-758, 64380-759, 64380-760, 0054-0140, 0054-0141, 0054-0142, 23155-147, 23155-148, 23155-149
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ACARBOSE
- RxCUI
- 199149, 199150, 200132
- SPL ID
- 458bb3c6-f92c-cf49-e063-6294a90a96c2, dad62dcf-e1fe-4982-aece-136f46269185, 2d7f6918-65c3-4db3-b775-b74e1e637cea, dc1b5c0e-cd6b-482e-9388-e9183ca499e9
- SPL set ID
- d1b627e1-d78d-47dd-93f5-2bf4998466ba, 656769ee-e292-4950-83df-a38e6b1a9d6e, 352dd336-d3f9-4ac5-a000-91d3aef7aca3, 29939129-7d09-4c22-bf3e-491a8a97f4c4
- Package NDC
- 62135-453-90, 62135-454-90, 62135-455-90, 64380-758-06, 64380-758-08, 64380-759-06, 64380-759-08, 64380-760-06, 64380-760-08, 0054-0140-25, 0054-0141-20, 0054-0141-25, 0054-0142-25, 23155-147-05, 23155-147-01, 23155-147-10, 23155-148-05, 23155-148-01, 23155-148-10, 23155-149-01, 23155-149-05, 23155-149-10
- Nui
- N0000000166, N0000175559
- Pharm class moa
- alpha Glucosidase Inhibitors [MoA]
- Pharm class epc
- alpha-Glucosidase Inhibitor [EPC]
- UNII
- T58MSI464G
- Drugcharacterization
- 2
- Medicinalproduct
- VALSARTAN
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- VALSARTAN
- Harmonized identifiers (openFDA)
- Application number
- ANDA202223, ANDA204038, ANDA209261, ANDA205347, ANDA203311, ANDA218991, ANDA216460, ANDA091367, ANDA205536, ANDA204821, ANDA214102, ANDA077492, ANDA201618, ANDA203536, ANDA201677, ANDA218897, ANDA204011, NDA021283, ANDA202696
- Brand name
- VALSARTAN, DIOVAN
- Generic name
- VALSARTAN, VALSARTAN ORAL
- Manufacturer name
- Aurobindo Pharma Limited, ScieGen Pharmaceuticals, INC., Unichem Pharmaceuticals (USA), Inc., SQUARE PHARMACEUTICALS LIMITED, Camber Pharmaceuticals, Inc., Zydus Lifesciences Limited, Advagen Pharma Ltd, Alembic Pharmaceuticals Limited, Ascend Laboratories, LLC, Viona Pharmaceuticals Inc, Solco Healthcare US, LLC, Alembic Pharmaceuticals Inc., ANI Pharmaceuticals, Inc., Ohm Laboratories Inc., Dr. Reddy's Laboratories Limited, Jubilant Cadista Pharmaceuticals Inc., Lifsa Drugs LLC, Lupin Pharmaceuticals, Inc., Laurus Labs Limited, Amneal Pharmaceuticals of New York LLC, Novartis Pharmaceuticals Corporation, Macleods Pharmaceuticals Limited, AvKARE
- Product NDC
- 65862-570, 65862-571, 65862-572, 65862-573, 50228-132, 50228-135, 50228-134, 50228-133, 29300-232, 29300-233, 29300-234, 29300-235, 76483-023, 76483-026, 76483-024, 76483-025, 31722-745, 31722-746, 31722-747, 31722-748, 70771-1882, 70771-1883, 70771-1884, 70771-1885, 72888-184, 46708-044, 46708-045, 46708-046, 46708-047, 67877-415, 67877-416, 67877-417, 67877-418, 72578-131, 72578-132, 72578-133, 72578-134, 43547-367, 43547-368, 43547-369 +50 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- VALSARTAN
- RxCUI
- 349199, 349200, 349201, 349483, 1996254, 351761, 351762, 352001, 352274
- SPL ID
- 7b329c09-5c17-4117-9cef-a383ecec90d9, 32318eee-6c28-4ec7-8a20-2089c6bd33eb, 4d1e743f-8954-4634-b95b-adb7ae41a549, 9f718442-a70e-4f30-8a1e-456392400ec0, 2b44fd7a-fd5a-984d-e063-6294a90a3fff, a69225f3-d9ea-4ed4-b7ab-225147cad486, 37380c18-7325-6166-e063-6294a90afbac, 3c6999e0-a1f1-40f0-8a6e-f3513410fd5d, b24a6cf6-a1b4-4d30-8a87-ec5ad793de42, 08731c4e-5c0c-4fba-b250-dbd17fd36e6e, bd8fb4f2-9d4a-4cf3-8b9e-cc5ba34bcea1, d9c3b1ac-bbb0-4974-b337-88e247093c72, 12e344cb-87c4-44a1-a59a-c6bcaaa6cb2c, 5863dfd5-e750-5523-e063-6294a90a9ef9, f7d1bd41-da10-005a-6e30-8a816db87867, 1e2b0e94-49d1-44bd-9564-20991a251f5a, dd4cbd3f-572e-400b-8fe7-98d537557b80, 4b026ec3-7e85-69ee-e063-6394a90a8c7f, b0ac78ab-2315-4aca-a405-bd86b8a08692, 6e1f63ad-e554-421b-a699-4e8c9bd4d239, 254b9473-bbcb-4780-a182-ba287b886a47, 8b57e357-5cfb-49a6-a600-59ce118fd1e9, 2481f60c-17b4-4b6f-946f-92c7928215b0, 488420ae-b4b5-d0ab-e063-6394a90a89bf
- SPL set ID
- a81a72dd-e828-4208-af9b-bb9ac4938537, 1a8af3d9-4053-4233-82a7-e8c7bc9e302f, 93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e, 5ee97546-2a7c-40fa-9e05-b7993a72dfbf, 0ff36e83-b307-42db-a2ab-bae3f6805c20, 1b60c816-7399-42c3-8b74-4dc9d82873ec, 47137b1a-f2b0-49af-99f0-6fb4f5a16578, 6e2cd953-88bf-4094-8ba8-2c9ba020f4d7, 7b4ecaf9-e84c-4660-9cd1-65a238efd8a8, bd7b35c7-9f01-4afd-b497-bbe0f3d69b29, 26080940-bcd3-446d-9026-3ddfb58e281e, 8478a05f-38fd-412d-af49-69a73a787c8f, 959b6790-feb7-45a9-9ea4-0ee1a7fce048, ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65, 75235313-8a07-8849-9b5a-12887992033e, 9402b022-5809-4251-dfef-54f6ef5723fe, 130e1659-9c2d-49ca-9db8-d28aa23fd133, d6e84105-9394-4ef0-928c-20d07d3fbaa9, 9eb9d98e-7057-4ca0-91ab-2030bc0120a6, 6e1f63ad-e554-421b-a699-4e8c9bd4d239, f13587f8-76cb-49ad-9291-5907249d6b8e, 5ddba454-f3e6-43c2-a7a6-58365d297213, 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46, a8c61488-4219-dfcb-e053-2a95a90a98a4
- Package NDC
- 65862-570-30, 65862-570-99, 65862-570-10, 65862-571-90, 65862-571-99, 65862-571-10, 65862-572-90, 65862-572-99, 65862-572-10, 65862-573-90, 65862-573-05, 50228-135-30, 50228-135-10, 50228-134-30, 50228-134-10, 50228-133-30, 50228-133-10, 50228-132-30, 50228-132-05, 29300-232-13, 29300-232-10, 29300-232-19, 29300-233-13, 29300-233-19, 29300-233-10, 29300-234-13, 29300-234-19, 29300-234-10, 29300-235-13, 29300-235-19, 29300-235-10, 76483-026-00, 76483-026-03, 76483-026-04, 76483-026-05, 76483-026-06, 76483-023-00, 76483-023-03, 76483-023-04, 76483-023-05 +244 more
- Nui
- N0000000070, N0000175561
- Pharm class moa
- Angiotensin 2 Receptor Antagonists [MoA]
- Pharm class epc
- Angiotensin 2 Receptor Blocker [EPC]
- UNII
- 80M03YXJ7I
- Drugcharacterization
- 2
- Medicinalproduct
- HYDROCHLOROTHIAZIDE
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Drugindication
- Product used for unknown indication
- Activesubstance
- Activesubstancename
- HYDROCHLOROTHIAZIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA087059, ANDA087068, ANDA090510, ANDA040702, ANDA040907, NDA219141, ANDA202556, ANDA040707, ANDA200645
- Brand name
- HYDROCHLOROTHIAZIDE, INZIRQO
- Generic name
- HYDROCHLOROTHIAZIDE
- Manufacturer name
- Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., LLC, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., ScieGen Pharmaceuticals Inc, Oxford Pharmaceuticals, LLC, Unichem Pharmaceuticals (USA), Inc., Leading Pharma, LLC, Exelan Pharmaceuticals Inc., ANI Pharmaceuticals, Inc., Accord Healthcare Inc., Rising Pharma Holdings, Inc., Actavis Pharma, Inc., Chartwell RX, LLC, Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc.
- Product NDC
- 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 23155-009, 23155-764, 50228-146, 65862-113, 69584-361, 69584-362, 29300-130, 69315-130, 69315-155, 69315-131, 76282-155, 76282-154, 70954-522, 16729-182, 16729-183, 16729-184, 57237-002, 29300-128, 29300-129, 29300-485, 0228-2820, 62135-448, 62135-738, 62135-449, 46708-438, 62332-070
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- HYDROCHLOROTHIAZIDE
- RxCUI
- 197770, 310798, 429503, 199903, 2704012, 2704018
- SPL ID
- db5cdbe8-1cd9-4bc3-a9b3-4fb4f053db3e, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4, a1057270-4261-4cac-bc26-2dbffb13eacb, 6847f060-0180-4f7e-aba8-4dce8c53e7ae, 7337a732-33b5-45d0-b460-0afcdf3a60a3, a86b0c8b-1ae7-4bfc-a236-c3d7fdd8959c, f1b356b8-32c9-43c5-b931-fa67e9b36fb7, 12cad736-bf18-4ad0-8118-efc502f33e87, 3a2fd599-143e-4dc4-b22c-e08f8b16a19e, d6ace9b2-f8fa-42b9-8338-9e2b5519ef6b, 4e6be915-b8a1-bef8-e063-6394a90a324c, adc31708-42a5-4529-ab66-b0445d1ba5e8, 1e92de42-a7f2-4674-8260-28cfabf0759d, 2b5bc2c3-8d3c-43c8-8e4c-e44aca5624cd, 459c0f0e-ee69-96b0-e063-6294a90a03a1, 8ed60738-80b1-4c2d-a0f1-cf5fa17f8308, b3a6e9ad-418d-420f-bb45-9c1bc8df2337
- SPL set ID
- 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c97ab9-b25e-4ea5-a159-792292178c65, c59c4230-7cea-4259-9f2f-6a568716fedf, 911a18c1-120a-46b3-b7a8-25eb37843473, e31bd548-29ae-419a-831a-80ebb26e042f, afbb9a0e-c22f-4133-8015-b4b2ab4d32e6, cb7712f3-9a0b-442d-859d-8be5e6e2529a, 8c868894-667e-4a51-906a-838d63e420ba, b5a1b38c-0433-4649-a8b0-f72db0a96c45, 41aaea48-6c1b-42c8-a96f-5923d49dc934, babb1b20-fe82-40ba-8e7a-0c56fe433b4a, 33f9c3ae-108d-469e-af6c-8be3b0f83139, 33f3b980-b339-4dbf-99bd-05588c2a298c, afdf1170-25a0-496d-b293-36ee0db2cd1e, 4e43dd27-3f4b-4205-a26e-6ecaa8281347, 34703033-14c4-459c-8b8f-2f2e1145aff7, 841b7962-bf5d-4c45-b594-80b17ba5187d
- Package NDC
- 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111-10, 50228-112-30, 50228-112-10, 43547-397-01, 43547-397-03, 43547-397-05, 43547-397-10, 43547-397-50, 43547-397-11, 43547-397-15, 43547-398-01, 43547-398-03, 43547-398-05, 43547-398-10, 43547-398-50, 43547-398-11, 23155-009-01, 23155-009-05, 23155-009-10, 23155-009-18, 23155-008-01, 23155-008-05, 23155-008-10, 23155-008-18, 23155-764-01, 23155-764-10, 50228-146-30, 50228-146-01, 50228-146-05, 50228-146-10, 65862-113-01, 65862-113-33, 65862-113-05, 65862-113-99, 69584-361-10 +59 more
- Nui
- N0000175359, N0000175419, M0471776
- Pharm class pe
- Increased Diuresis [PE]
- Pharm class epc
- Thiazide Diuretic [EPC]
- Pharm class cs
- Thiazides [CS]
- UNII
- 0J48LPH2TH
- Drugcharacterization
- 2
- Medicinalproduct
- Salmeterol / fluticasone propionate
- Drugbatchnumb
- Unknown
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugindication
- Product used for unknown indication