Upper gastrointestinal haemorrhage, Dizziness, Asthenia
Drugs: BRILINTA, ASPIRIN
- Safetyreportversion
- 1
- Safetyreportid
- 27325220
- Primarysourcecountry
- CN
- Occurcountry
- CN
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 1
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- CN-ASTRAZENECA-202609CHN023069CN
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- NMPACDR
- Duplicatenumb
- 15542055584986562569617
- Primarysource
- Reportercountry
- CN
- Qualification
- 3
- Sender
- Sendertype
- 6
- Senderorganization
- ALEXION PHARMACEUTICALS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 63
- Patientonsetageunit
- 801
- Patientagegroup
- 5
- Patientweight
- 65
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Upper gastrointestinal haemorrhage
- Reactionoutcome
- 2
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Dizziness
- Reactionoutcome
- 2
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Asthenia
- Reactionoutcome
- 2
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- BRILINTA
- Drugbatchnumb
- 2605118
- Drugauthorizationnumb
- 22433
- Drugstructuredosagenumb
- 180
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugcumulativedosagenumb
- 149760
- Drugcumulativedosageunit
- 003
- Drugdosagetext
- 180 MILLIGRAM, BID
- Drugadministrationroute
- 061
- Drugindication
- Antiplatelet therapy
- Drugstartdateformat
- 102
- Drugstartdate
- 20250410
- Drugenddateformat
- 102
- Drugenddate
- 20260530
- Drugtreatmentduration
- 416
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- TICAGRELOR
- Harmonized identifiers (openFDA)
- Application number
- NDA022433
- Brand name
- BRILINTA
- Generic name
- TICAGRELOR
- Manufacturer name
- AstraZeneca Pharmaceuticals LP
- Product NDC
- 0186-0776, 0186-0777
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- TICAGRELOR
- RxCUI
- 1116635, 1116639, 1666332, 1666334
- SPL ID
- a9148b29-a2e9-4222-bf15-b55045ac1fe2
- SPL set ID
- f7b3f443-e83d-4bf2-0e96-023448fed9a8
- Package NDC
- 0186-0777-08, 0186-0777-60, 0186-0777-18, 0186-0777-39, 0186-0777-28, 0186-0776-60, 0186-0776-94
- Nui
- N0000182142, N0000008832, N0000182143, N0000182141, N0000185503
- Pharm class epc
- P2Y12 Platelet Inhibitor [EPC]
- Pharm class pe
- Decreased Platelet Aggregation [PE]
- Pharm class moa
- P2Y12 Receptor Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- UNII
- GLH0314RVC
- Drugcharacterization
- 1
- Medicinalproduct
- ASPIRIN
- Drugbatchnumb
- 26276720
- Drugstructuredosagenumb
- 100
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugcumulativedosagenumb
- 41600
- Drugcumulativedosageunit
- 003
- Drugdosagetext
- 100 MILLIGRAM, QD
- Drugadministrationroute
- 061
- Drugindication
- Antiplatelet therapy
- Drugstartdateformat
- 102
- Drugstartdate
- 20250410
- Drugenddateformat
- 102
- Drugenddate
- 20260530
- Drugtreatmentduration
- 416
- Drugtreatmentdurationunit
- 804
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Drugadditional
- 1
- Activesubstance
- Activesubstancename
- ASPIRIN
- Harmonized identifiers (openFDA)
- Application number
- M013, M013.50, part343, M
- Brand name
- BAYER GENUINE ASPIRIN, ASPIRIN, ADULT LOW DOSE ASPIRIN, DRUG MART EFFERVESCENT PAIN RELIEF, ASPIRIN LOW DOSE, ASPIRIN ENTERIC COATED, ASPIRIN 81, ADULT CHEWABLE ASPIRIN, ASPIRIN 81MG, ADULT LOW DOSE ENTERIC COATED ASPIRIN, ASPIRIN LOW DOSE SAFETY COATED, GERITREX ASPIRIN, BUFFERED ASPIRIN, ENTERIC COATED ASPIRIN, BUFFERIN REGULAR STRENGTH PAIN RELIEF, WISPIRIN, EQUATE ASPIRIN, LOW DOSE ASPIRIN, HEB EFFERVESCENT PAIN RELIEF, PAIN RELIEF ASPIRIN LOW DOSE, ASPIRIN 81 MG LOW DOSE, ASPIRIN EXTRA STRENGTH, BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED, TRAVEL SAVVY ASPIRIN, CHEWABLE ASPIRIN 81 MG, TOPCARE ASPIRIN, RAPIDOL ASPIRIN, CAREALL ASPIRIN, ASPIRIN REGULAR STRENGTH, REGULAR STRENGTH ASPIRIN, LOW DOSE MINIPRIN ENTERIC SAFETY COATED, ASPIRIN DELAYED RELEASE, GOOD NEIGHBOR PHARMACY ASPIRIN, CHEWABLE ASPIRIN, LEADER ASPIRIN, CHEWABLE LOW DOSE ASPIRIN, CIRCLE K ASPIRIN 325, LOW DOSE ASPIRIN ENTERIC SAFETY COATED, ASPIRIN 81MG ENTERIC COATED, CHILDRENS ASPIRIN +86 more
- Generic name
- ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG
- Manufacturer name
- Unifirst First Aid Corporation, Health Pharma USA LLC, Topco Associates, LLC, Advanced Rx LLC, Discount Drug Mart Inc, STRATEGIC SOURCING SERVICES LLC, L.N.K. International, Inc., Grocery Outlet, Rising Pharma Holdings, Inc., HARRIS TEETER, BETTER LIVING BRANDS LLC., Bi-Mart, Trifecta Pharmaceuticals USA LLC, Marc Glassman, Inc., Care One (Retail Business Services, LLC.), Geritrex LLC, Cardinal Health 110, LLC. DBA Leader, DISCOUNT DRUG MART, Genomma Lab USA, Wisdrug AG, Wal-Mart Stores Inc, Advance Pharmaceutical Inc., P & L Development, LLC, H. E. BUTT GROCERY COMPANY, Rite Aid Corporation, Richmond Pharmaceuticals, Inc., Magno-Humphries, Inc., CHAIN DRUG MARKETING ASSOCIATION, INC., Time-Cap Labs, Inc, Bayer HealthCare LLC., Allegiant Health, Bellegrove Medical Supply, Inc., Padagis US LLC, United Natural Foods, Inc. dba UNFI, PROSTAT FIRST AID, Walgreen Company, HYVEE INC, Topco Associates LLC, COSTCO WHOLESALE CORPORATION, Geri-Care Pharmaceutical Corp +117 more
- Product NDC
- 47682-456, 71679-302, 36800-545, 80513-289, 53943-431, 70677-1121, 50844-600, 85828-372, 57237-302, 72036-252, 21130-428, 37835-571, 69396-173, 68998-146, 72476-263, 54162-940, 70000-0147, 53943-081, 50066-610, 87580-001, 49035-467, 17714-009, 59726-065, 37808-861, 70000-0253, 11822-0600, 54738-128, 54257-274, 83324-090, 49483-382, 0280-2090, 69168-318, 59961-616, 59961-620, 0574-7034, 17714-010, 41163-563, 58228-0071, 0363-0218, 42507-605 +270 more
- Product type
- HUMAN OTC DRUG
- Route
- ORAL, RECTAL
- Substance name
- ASPIRIN
- RxCUI
- 211874, 212033, 308416, 2606079, 318272, 198467, 260847, 198471, 825180, 198464, 1052678, 387090, 212086, 794229, 1189781, 243670, 749795, 211832
- SPL ID
- 3e5d2e28-1c08-7a10-e063-6294a90a551e, 50385717-c87c-b515-e063-6394a90aa371, 035fcef2-398e-401b-90b2-33cf5b522c04, 38ec4680-85ec-6450-e063-6294a90aeb69, 1c35f394-a222-6531-e063-6394a90acb8a, 24b274d6-f226-07eb-e063-6394a90a1d7d, 62d04705-d057-45a8-b5c3-18c9c82caa65, 2f13f7b8-33e5-4f1d-91f2-d210ed8c72d2, ffa0c51f-1493-4897-99cf-8ae6ab2a6f05, 58debf07-b093-bc03-e063-6294a90a28fa, 2d62fa1e-80f4-1f9e-e063-6394a90a575d, 31151537-fd19-b17e-e063-6394a90aad81, 372be4d6-cde3-c6a2-e063-6294a90a8825, 27d89e9f-7a2e-1bb8-e063-6394a90a4b4e, c1884ada-373c-47d9-8b7f-63b9d9067ac1, cc723205-04c3-410f-8fa1-93900afb9142, d10425d7-6e69-45d3-b91d-c02f5884923d, 249d869c-d17e-ebcb-e063-6394a90a94b6, 4f652a68-82a2-4c22-acc4-2cb28f96b358, 4e70ec5e-d034-a525-e063-6394a90a5a93, 07be5485-529c-4f12-ab56-55296f3691ee, 2a32783c-571f-26cb-e063-6394a90af066, 008ee85b-5cac-45a6-a857-a828f8125175, 285f424d-b50c-c734-e063-6394a90a9680, a5bb5d00-5da7-4488-8683-b4ae43a2125f, 03139c1b-6cee-4d3c-89dd-b07596d75ee7, 5cc44dca-00c9-b589-e053-2a91aa0a0521, 08bf7b4e-4f73-7538-e063-6394a90a6627, 1ac70227-c7c3-de60-e063-6394a90aeed7, 7d3ee158-5996-c9c6-e053-2991aa0a844a, 4526b3d0-3666-afe5-e063-6294a90af3ab, e6eab4fe-e1dc-4b80-9711-d4c74618eb4b, 3e5d63ea-c1b6-f7fc-e063-6394a90ae253, a6ca751c-7438-4a0f-adae-d176f73f4915, 5cc8b5f1-4ae4-471b-e053-2991aa0a84c1, 180c7e2b-b245-43e4-a26d-4e8b083d7a86, 3bdb9dec-858a-3145-e063-6394a90acd0d, e38f2a95-358e-4403-8a80-8598a13f455b, 484bf6d3-b6b3-8d71-e063-6294a90a3e58, f81a8e68-63f5-445f-9d86-b82e04d7a191 +255 more
- SPL set ID
- 356e4ff4-a7f1-4a50-9b86-2555e232b300, 503868bb-48e0-b718-e063-6394a90a9c5b, 56c125de-fabf-41fa-88a4-760d2793f202, ad0d6a5c-eee9-406c-8d7f-1df9b45f5340, 1c35f394-a221-6531-e063-6394a90acb8a, 2ca87a29-1f54-4da4-a66f-3b3dd4f0396c, 2f6ec676-3832-420e-be91-fce83f6586c8, 79c64e27-87aa-4081-8cbf-343768b00b90, bfc4fd55-45db-41f4-b878-a6b7155f0849, c6a28617-1769-7a7d-e053-2995a90a1ea0, f300dfbc-7137-79d1-e053-2995a90a636e, 08769966-2f6e-4fce-8391-ec1910ab5e7a, 372be427-acbd-c10c-e063-6294a90a572d, 3d519af3-9398-4439-8253-1e5d4612b8e3, 6659e103-fa03-4de0-af42-d2fbd548a87c, 93fb4359-c93d-46c4-b36e-611b829f514c, e5f68c1a-21f3-45a1-861f-229a95b3721c, 03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48, 3543b2bf-1062-468a-a5dc-eabb2408af8c, 4e70ec5e-d033-a525-e063-6394a90a5a93, ea3f8eed-7b70-4156-9586-125d27bf29a8, f6a9ea44-08b8-4a33-bfbd-68cb2d852c39, 0058175f-3474-40c3-a046-6cfaec86d84b, 03876c71-60ec-3280-e063-6294a90a62dc, 318cc982-23a9-4804-b6fb-248f772d7a38, 503408ed-e799-48a0-8d38-3034f4a0ead5, 6a4c897d-c2a8-41b8-98b7-e7da8e2819ec, a7c02378-4213-4e57-aca2-2437ad02f786, bfb9af64-3195-44bf-bcf3-6b36b40d3cc7, efc7d42a-241a-422d-bc08-be2f5f774b62, 070d5713-e018-2913-e054-00144ff8d46c, 3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5, bae80044-ad7f-3bf5-e053-2995a90a42f9, cce244aa-cd79-49c8-b68e-267f2bd0ef67, f2e7332a-bcd6-4aef-9e4c-a2cef5ea9464, 18b79449-5c4c-41ce-9609-80f5efa0375c, 3bdb9d89-9000-69f9-e063-6294a90a0c97, 413b3b95-2867-4534-8290-54f477cccf1e, 459f749f-9d23-8752-e063-6394a90a8c81, 8133c3fc-97ce-46b4-8580-7da9f09f622b +255 more
- Package NDC
- 47682-456-50, 47682-456-47, 71679-302-00, 36800-545-60, 80513-289-03, 53943-431-36, 70677-1121-1, 50844-600-32, 50844-600-95, 50844-600-14, 50844-600-01, 50844-600-17, 85828-372-17, 57237-302-12, 57237-302-10, 72036-252-01, 21130-428-12, 21130-428-20, 37835-571-12, 37835-571-05, 69396-173-01, 68998-146-01, 72476-263-12, 72476-263-30, 54162-940-90, 70000-0147-1, 53943-081-02, 50066-610-13, 50066-610-30, 87580-001-01, 49035-467-68, 49035-467-08, 17714-009-36, 59726-065-30, 37808-861-36, 70000-0253-2, 70000-0253-4, 70000-0253-1, 70000-0253-3, 11822-0600-6 +576 more
- Nui
- N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832
- Pharm class moa
- Cyclooxygenase Inhibitors [MoA]
- Pharm class pe
- Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]
- Pharm class cs
- Anti-Inflammatory Agents, Non-Steroidal [CS]
- Pharm class epc
- Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
- UNII
- R16CO5Y76E
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260530