{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "21309731", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20240716", "reporttype": "2", "serious": "2", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20220908", "receiptdateformat": "102", "receiptdate": "20240423", "fulfillexpeditecriteria": "2", "companynumb": "US-ACADIA PHARMACEUTICALS INC.-ACA-2022-PIM-002784", "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", 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"13668-180", "13668-181", "13668-182", "27808-155", "27808-156", "27808-157", "27808-158", "70377-006", "70377-007", "70377-008", "70377-009", "71209-043", "71209-044", "71209-045", "71209-046", "65862-293", "65862-294", "65862-295", "65862-296", "72303-0827", "72303-0828", "72303-0829", "72303-0830", "69367-359", "69367-360", "69367-361", "69367-362", "13668-720", "13668-721", "13668-722", "13668-723" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ROSUVASTATIN CALCIUM" ], "rxcui": [ "859419", "859424", "859747", "859751" ], "spl_id": [ "f378d351-0576-4496-baca-a2858712bc5c", "86597300-9b2c-44cf-9650-503f5bdbf5bb", "62787a4a-6d53-43a3-a0b7-ed0b6037d18e", "05d54625-511b-4cba-818b-e77e3e6b17a3", "5368ad40-da32-8cfd-e063-6294a90ae598", "54957f99-e5ff-dbab-e063-6294a90ad4cd", "760efcac-6dbc-4e58-b2cc-9fc5f9b5603f", "39b848aa-fb65-4b04-916c-1c83589ff3ce", "52c7b3fe-56c6-3cd9-e063-6294a90acfbb", "e6a44b24-b851-40c2-92ef-ee7e9fe0d2db", "af3a6349-8b25-462d-9fbf-3e95c32734df", "a922bb47-91e3-4103-9edb-d9431a38d398", "6c4547c4-9429-42e5-998f-e97f6a74f150", "843cb1f2-e29f-1cea-4a98-e34470827fba", "1fa3517d-f34d-430d-89e0-8b4c9d923f77", "3073eb2c-5f7f-46ec-81aa-97db900472eb", "57a6409f-9fd1-54ae-e063-6294a90ae490", "447c034b-bd46-2a37-e063-6394a90a4feb", "5a7f22c1-173a-e853-e063-6394a90a4556" ], "spl_set_id": [ "40c2900e-4659-49ce-ba4b-5df529b3c53b", "6f978191-775e-4745-9c07-99e5be888afe", "d58f1f63-4bb6-413c-9730-ded3e8078618", "5c992d3d-d754-48b6-a267-1451208352ed", "989dffcf-0254-439d-9f3f-3b0e9d32de0a", "c622757d-7370-438b-8c2d-ef444a4f31dd", "392657a9-955c-42c2-814c-1890ece45afa", "9333c674-5714-41ed-8a16-dc7c3e50b9a4", "ae865404-ecf4-41a8-b40b-62f887c220f2", "4ccbaa83-d57a-421e-88a8-1cee42d4207b", "17d71c80-fade-4735-acec-60738d26dd01", "8c2d481f-53f2-4cf6-bd28-7d92323785cd", "606d16fb-82e4-420d-9456-09997562b528", "033d8c8f-bbe9-96b5-fd53-cb0ef929857a", "6802a946-a29c-4d41-997b-3c078ed8e74d", "47924917-bbd5-45de-96cb-c7ff9754da97", "568a782b-1621-5e59-e063-6294a90a7fef", "02797697-300a-43db-92cf-9b78f08626be", "6985e729-d963-4f32-89a1-727472b86daa" ], "package_ndc": [ "69434-005-02", "69434-005-03", "69434-006-02", "69434-006-03", "69434-007-02", "69434-007-03", "69434-008-01", "69434-008-03", "82009-018-90", "82009-018-10", "82009-019-90", "82009-019-10", "82009-020-30", "82009-020-10", "82009-017-90", "82009-017-10", "72205-003-90", "72205-003-99", "72205-003-11", "72205-003-06", "72205-003-05", "72205-004-90", "72205-004-99", "72205-004-11", "72205-004-06", "72205-004-05", "72205-005-30", "72205-005-90", "72205-005-99", "72205-005-11", "72205-005-06", "72205-005-05", "72205-027-90", "72205-027-99", "72205-027-11", "72205-027-06", "72205-027-05", "72205-002-90", "72205-002-99", "72205-002-11", "72205-002-06", "72205-002-05", "57237-168-30", "57237-168-90", "57237-168-05", "57237-168-99", "57237-169-30", "57237-169-90", "57237-169-05", "57237-169-99", "57237-170-30", "57237-170-90", "57237-170-05", "57237-170-99", "57237-171-30", "57237-171-90", "57237-171-05", "57237-171-99", "60290-043-01", "60290-043-02", "60290-043-03", "60290-043-04", "60290-043-05", "60290-044-01", "60290-044-02", "60290-044-03", "60290-044-04", "60290-044-05", "60290-045-01", "60290-045-02", "60290-045-03", "60290-045-04", "60290-045-05", "60290-046-01", "60290-046-02", "60290-046-03", "60290-046-04", "60290-046-05", "72603-364-01", "72603-364-02", "72603-365-01", "72603-365-02", "72603-366-01", "72603-366-02", "72603-366-03", "72603-367-01", "72603-367-02", "72603-367-03", "72603-367-04", "68462-261-30", "68462-261-50", "68462-261-90", "68462-261-01", "68462-261-10", "68462-261-11", "68462-262-30", "68462-262-50", "68462-262-90", "68462-262-01", "68462-262-10", "68462-262-11", "68462-263-30", "68462-263-50", "68462-263-90", "68462-263-01", "68462-263-10", "68462-263-11", "68462-264-30", "68462-264-50", "68462-264-90", "68462-264-01", "68462-264-05", "68462-264-10", "24658-261-90", "24658-262-90", "24658-262-45", "24658-263-90", "24658-263-45", "24658-264-90", "24658-264-45", "24658-264-30", "42677-301-01", "42677-301-02", "42677-302-01", "42677-302-02", "42677-303-01", "42677-303-02", "42677-304-01", "42677-304-02", "67877-439-30", "67877-439-90", "67877-439-05", "67877-439-38", "67877-440-30", "67877-440-90", "67877-440-05", "67877-440-38", "67877-441-30", "67877-441-90", "67877-441-05", "67877-441-38", "67877-442-30", "67877-442-90", "67877-442-05", "67877-442-38", "16714-988-01", "16714-989-01", "16714-990-01", "16714-991-01", "13668-179-30", "13668-179-90", "13668-179-05", "13668-180-90", "13668-180-05", "13668-180-30", "13668-181-90", "13668-181-30", "13668-181-05", "13668-182-30", "13668-182-90", "13668-182-05", "27808-156-01", "27808-156-03", "27808-156-02", "27808-157-01", "27808-157-03", "27808-157-02", "27808-158-03", "27808-158-01", "27808-158-02", "27808-155-01", "27808-155-03", "27808-155-02", "70377-006-11", "70377-006-12", "70377-006-13", "70377-006-15", "70377-007-11", "70377-007-12", "70377-007-13", "70377-007-15", "70377-008-11", "70377-008-12", "70377-008-13", "70377-008-15", "70377-009-11", "70377-009-12", "70377-009-13", "70377-009-15", "71209-043-04", "71209-044-04", "71209-045-04", "71209-046-01", "65862-293-30", "65862-293-90", "65862-293-05", "65862-293-99", "65862-293-06", "65862-294-30", "65862-294-90", "65862-294-05", "65862-294-99", "65862-294-06", "65862-295-30", "65862-295-90", "65862-295-05", "65862-295-99", "65862-295-06", "65862-296-30", "65862-296-90", "65862-296-05", "65862-296-99", "65862-296-10", "72303-0827-1", "72303-0828-1", "72303-0829-1", "72303-0830-1", "69367-359-05", "69367-359-30", "69367-359-09", "69367-359-10", "69367-359-01", "69367-360-10", "69367-360-30", "69367-360-09", "69367-360-05", "69367-360-01", "69367-361-09", "69367-361-01", "69367-361-05", "69367-361-10", "69367-361-30", "69367-362-01", "69367-362-05", "69367-362-30", "69367-362-09", "13668-720-90", "13668-720-05", "13668-720-10", "13668-721-90", "13668-721-05", "13668-721-10", "13668-722-90", "13668-722-05", "13668-722-10", "13668-723-30", "13668-723-05", "13668-723-10" ], "unii": [ "83MVU38M7Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PHOSPHORIC ACID\\SODIUM PHOSPHATE, DIBASIC", "activesubstance": { "activesubstancename": "PHOSPHORIC ACID\\SODIUM PHOSPHATE, DIBASIC" } }, { "drugcharacterization": "2", "medicinalproduct": "CANNABIDIOL", "activesubstance": { "activesubstancename": "CANNABIDIOL" }, "openfda": { "application_number": [ "NDA210365" ], "brand_name": [ "EPIDIOLEX" ], "generic_name": [ "CANNABIDIOL" ], "manufacturer_name": [ "Jazz Pharmaceuticals, Inc." ], "product_ndc": [ "70127-100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CANNABIDIOL" ], "rxcui": [ "2058900", "2058906" ], "spl_id": [ "1eb7ac65-8df5-4a4a-9156-802cfaa92b06" ], "spl_set_id": [ "8bf27097-4870-43fb-94f0-f3d0871d1eec" ], "package_ndc": [ "70127-100-01", "70127-100-10", "70127-100-06", "70127-100-60" ], "nui": [ "M0003267", "N0000187062", "N0000185504", "N0000182140", "N0000191278", "N0000191273", "N0000182138", "N0000182139", "N0000187064" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]" ], "unii": [ "19GBJ60SN5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MIRALAX", "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "openfda": { "application_number": [ "NDA022015" ], "brand_name": [ "MIRALAX" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "11523-4357", "11523-7268", "11523-7234", "11523-7341" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350" ], "rxcui": [ "876193", "876195" ], "spl_id": [ "51040c1b-71bf-bb83-e063-6294a90aca4e" ], "spl_set_id": [ "d69ce3d4-7ca4-4fe3-b49e-6655e48d6963" ], "package_ndc": [ "11523-7268-3", "11523-7268-8", "11523-7268-7", "11523-7268-4", "11523-7268-9", "11523-7268-5", "11523-7234-1", "11523-7234-2", "11523-7234-3", "11523-7234-4", "11523-7234-5", "11523-7234-6", "11523-7234-9", "11523-7341-1", "11523-7341-2", "11523-4357-1", "11523-4357-3", "11523-4357-5", "11523-4357-2" ], "nui": [ "N0000010288", "N0000175811", "N0000009871" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20220101" } } } ] }