{ "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": 617 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10046329", "primarysourcecountry": "FR", "occurcountry": "FR", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140331", "receiptdateformat": "102", "receiptdate": "20140424", "fulfillexpeditecriteria": "1", "companynumb": "FR-009507513-1403FRA010403", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERCK", "duplicatenumb": "FR-009507513-1403FRA010403" }, "primarysource": { "reportercountry": "FR", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "34", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hepatocellular injury", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Haematocrit increased", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Ascites", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vomiting", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Ovarian hyperstimulation syndrome", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "GONADOTROPHINE CHORIONIQUE ENDO 5000 UI/1ML", "drugauthorizationnumb": "017692", "drugstructuredosagenumb": "10000", "drugstructuredosageunit": "025", "drugcumulativedosagenumb": "10000", "drugcumulativedosageunit": "025", "drugdosagetext": "10000 IU, ONCE", "drugdosageform": "POWDER FOR INJECTION", "drugadministrationroute": "030", "drugindication": "IN VITRO FERTILISATION", "drugstartdateformat": "102", "drugstartdate": "20140206", "drugenddateformat": "102", "drugenddate": "20140206" }, { "drugcharacterization": "1", "medicinalproduct": "CETROTIDE", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "10", "drugcumulativedosageunit": "032", "drugdosagetext": "1 DF, QD", "drugdosageform": "POWDER FOR INJECTION", "drugadministrationroute": "058", "drugindication": "IN VITRO FERTILISATION", "drugstartdateformat": "102", "drugstartdate": "20140127", "drugenddateformat": "102", "drugenddate": "20140205", "openfda": { "application_number": [ "NDA021197" ], "brand_name": [ "CETROTIDE" ], "generic_name": [ "CETRORELIX ACETATE" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-1225" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "rxcui": [ "283402", "284441" ], "spl_id": [ "716029d9-4462-4732-846c-456e74363b83" ], "spl_set_id": [ "aca7768e-28a7-4027-b1d8-e66247665f79" ], "package_ndc": [ "44087-1225-1" ] } }, { "drugcharacterization": "1", "medicinalproduct": "GONAL-F", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "10", "drugcumulativedosageunit": "032", "drugdosagetext": "1 DF, QD", "drugdosageform": "POWDER FOR INJECTION", "drugadministrationroute": "058", "drugindication": "IN VITRO FERTILISATION", "drugstartdateformat": "102", "drugstartdate": "20140127", "drugenddateformat": "102", "drugenddate": "20140205", "openfda": { "application_number": [ "BLA020378" ], "brand_name": [ "GONAL-F" ], "generic_name": [ "FOLLITROPIN ALFA" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-9030", "44087-9070" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "rxcui": [ "351125", "351993" ], "spl_id": [ "cce3fe26-e11c-4cc9-9cf9-5841913db5ba" ], "spl_set_id": [ "ae85b9c3-e7eb-4981-a5d9-346050e8f189" ], "package_ndc": [ "44087-9030-1", "44087-9070-1" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PROGESTERONE", "drugdosagetext": "UNK", "drugindication": "IN VITRO FERTILISATION", "drugstartdateformat": "610", "drugstartdate": "201402", "drugenddateformat": "102", "drugenddate": "20140225", "actiondrug": "4", "openfda": { "brand_name": [ "PROGESTERONE", "PROGESTERONE VAGINAL INSERTS", "PROGESTERONE VAGINAL INSERT", "PROGESTERONE COMBO", "P50 PROGESTERONE CREAM", "P75 LAV PROGESTERONE CREAM", "PROGESTERONE 1538", "BUNUSS PHYTO-PRO SKIN CREAM", "PROGESTERONE PHENOLIC", "CRINONE", "NATURAL PROGESTERONE", "PROMETRIUM", "P25 PROGESTERONE CREAM", "ENDOMETRIN" ], "generic_name": [ "PROGESTERONE" ], "manufacturer_name": [ "BioActive Nutritional, Inc.", "Sun Pharmaceutical Industries, Inc.", "Glenmark Pharmaceuticals Inc., USA", "Fresenius Kabi USA, LLC", "Bionpharma Inc.", "XIROMED, LLC", "Nutritional Specialties, Inc.", "SHYNE BRANDS", "Hikma Pharmaceuticals USA Inc", "AvKARE", "Amneal Pharmaceuticals LLC", "Eugia US LLC", "Professional Complementary Health Formulas", "Aurobindo Pharma Limited", "Jiashen International Trade Limited", "Newton Laboratories, Inc.", "NorthStar Rx LLC", "Energique, Inc.", "Northstar Rx LLC", "Allergan, Inc.", "Dr. Reddys Laboratories, Inc.", "Hikma Pharmaceuticals USA Inc.", "Acertis Pharmaceuticals, LLC", "Ferring Pharmaceuticals Inc.", "Xiromed, LLC", "Deseret Biologicals, Inc." ], "product_ndc": [ "43857-0120", "70095-136", "68462-175", "63323-261", "43857-0103", "69452-148", "69452-149", "70700-201", "83027-0073", "82018-0012", "82018-0014", "0054-0829", "0054-0830", "73190-064", "73190-065", "65162-807", "65162-808", "55150-306", "63083-1538", "59651-152", "59651-153", "84867-030", "70700-286", "55714-9004", "72603-974", "72603-975", "42291-784", "42291-785", "44911-0047", "16714-157", "16714-158", "0023-6150", "0023-6151", "43598-349", "43598-350", "43857-0084", "0143-9725", "72989-372", "72989-373", "82018-0011", "55566-6500", "69452-233", "69452-234", "70700-162", "70700-163", "43742-0851" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "VAGINAL", "INTRAMUSCULAR", "TRANSDERMAL", "TOPICAL" ], "substance_name": [ "PROGESTERONE" ], "spl_id": [ "eade2a6a-d551-4c49-84b2-256593363a93", "5232dd12-1767-7fa2-e063-6294a90a4e70", "41682665-e889-4e2a-9382-88f6bcc30237", "e03e68a3-f9df-4c3f-bd1f-30fae68433f3", "d1c58e66-a542-42a8-b67a-8928a8c07c2d", "73113fdd-1ff9-419e-8c29-3e82c8898cce", "5264f1f1-0a2d-1506-22f5-71074729ece9", "28ef8ea9-9588-4eca-8585-647c9a5dbf3c", "3792493b-80b7-2a3e-e063-6394a90aed7c", "37921252-d79f-1cd9-e063-6394a90a97cc", "f38dd5d9-88b1-4792-bbb9-5f589d9539b0", "5464d63c-b472-ca58-e063-6294a90a3b7a", "6f7c3e58-3b68-4d6f-8502-74a41478d1c4", "44ca9ab1-7336-4914-b059-79559747ac39", "18ebd793-0def-4781-8589-ac376d47cb88", "7bcfeb57-0490-4e12-9e4b-a46c1f55034d", "44e1ec89-e2eb-d438-e063-6294a90a41f4", "0f25eef8-d21f-138d-dd9c-550b42f355dc", "2dd20a86-4e3f-0173-e063-6294a90a0cfe", "f392c6d9-1420-4735-aa01-f434da9b31b3", "51b5c47b-1c07-0bfb-e063-6294a90aab09", "079ad30c-1a0d-475b-8043-62ad1f46fb1d", "b1c812dd-e2c9-b0d0-8ba1-f566ab129797", "ab1523af-0bbb-4231-a12c-ac52e3ec91cd", "4b8f3d16-f096-32f0-65f9-230ab8c292b7", "d30b761b-1887-41be-b9c2-a83b4c2520c0", "1c879c94-73fc-4e22-8edc-366802f9714a", "4ff93bfe-305d-4956-bec9-5ac1d469b34f", "3791c949-aa9f-0039-e063-6394a90a56ba", "7ff9c412-250d-4db8-b425-51c200241848", "52f7a501-4d23-0fbc-e063-6394a90a4b94", "181873be-16cc-352d-9568-03af070a1fc1", "f85df087-4485-48ab-887c-9705ddabd166" ], "spl_set_id": [ "cddb5afa-9825-418d-acf6-cffbb0fc39c3", "fcdde0d0-4329-4725-a76b-684f9d97fe95", "41682665-e889-4e2a-9382-88f6bcc30237", "a479b395-1e1a-4d2a-8feb-68a15c47225f", "0de91238-dacc-4a5c-86d8-ad94024b2c95", "3acad9b0-7ec6-4d5e-9852-32ffadbbed6d", "473ab609-5b9e-3cb8-68d5-4a459a2ea6c1", "5ccf7bee-2da4-4347-8753-30680d7c1c03", "c47121df-6c04-b273-e053-2a95a90aa549", "c4711337-7c1f-3556-e053-2a95a90a7b82", "d8bcc439-c21d-4eeb-9159-f51e0c60bd70", "42c84fec-e5eb-78f7-e063-6294a90a4c0e", "4de0715d-a3b9-42fa-b4e4-6371151fd75c", "7d19df3b-94ed-4681-beae-9caaf137d014", "a5b8449e-ae6f-48c1-8b71-2dd3c5332cc1", "7d73f08d-2de7-44b6-9e44-2d488fe02517", "44e1ec89-e2ea-d438-e063-6294a90a41f4", "dcfa4050-d142-b774-369f-8a421eb23c62", "9e038e0b-a124-1870-e053-2995a90a49f8", "f392c6d9-1420-4735-aa01-f434da9b31b3", "1637ac18-3a37-f3d5-e063-6394a90af157", "177c7d38-d133-4e3b-a81e-f6bacd39b147", "73229a76-8de3-4cea-886f-568f0b817fea", "75e97aa1-daa4-45f9-b2e2-1a371302914e", "efded380-02ff-68c9-13e4-47a561ede440", "772629aa-af5e-4493-aaf2-3c75bfd7d8c2", "83cfc12e-75d1-4284-bcc3-beadcbd27171", "1cf237ff-c4f8-4faa-a7aa-77599c856889", "c47169b7-1b6a-2ad0-e053-2995a90a0b19", "2ba50fa9-b349-40cb-9a4b-1af8faa4ec09", "41b3c3a7-5fb8-4451-a96c-2bd02613c021", "0bf317a8-96d6-849d-7850-9084205a5315", "ef33af80-5f72-4635-a8ae-f48376efb451" ], "package_ndc": [ "43857-0120-1", "70095-136-01", "70095-136-02", "70095-136-03", "68462-175-40", "68462-175-33", "63323-261-10", "43857-0103-1", "69452-148-20", "69452-149-20", "70700-201-68", "70700-201-69", "70700-201-70", "83027-0073-1", "82018-0012-6", "82018-0014-8", "0054-0829-25", "0054-0830-25", "73190-064-01", "73190-065-01", "65162-807-10", "65162-807-50", "65162-808-10", "65162-808-50", "55150-306-10", "63083-1538-1", "59651-152-01", "59651-153-01", "84867-030-01", "70700-286-22", "55714-9004-1", "72603-974-01", "72603-975-01", "42291-784-01", "42291-784-30", "42291-785-01", "42291-785-30", "44911-0047-1", "16714-157-01", "16714-158-01", "0023-6150-04", "0023-6151-08", "43598-349-01", "43598-350-01", "43857-0084-1", "0143-9725-01", "72989-372-30", "72989-373-30", "82018-0011-5", "55566-6500-1", "55566-6500-2", "55566-6500-3", "55566-6500-4", "55566-6500-7", "55566-6500-8", "69452-233-20", "69452-234-20", "70700-162-01", "70700-163-01", "43742-0851-1" ], "nui": [ "M0017672", "N0000175601" ], "pharm_class_cs": [ "Progesterone [CS]" ], "pharm_class_epc": [ "Progesterone [EPC]" ], "unii": [ "4G7DS2Q64Y" ], "application_number": [ "NDA022057", "ANDA216363", "ANDA075906", "ANDA200900", "ANDA218391", "ANDA200456", "ANDA207724", "ANDA210965", "ANDA211285", "ANDA215634", "ANDA205229", "NDA020701", "ANDA208801", "ANDA091033", "NDA019781" ], "rxcui": [ "725094", "312644", "260243", "312641", "153579", "153580", "312643", "312645", "261319", "262080", "725098" ] } } ] } } ] }