{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 118455
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10004513",
      "primarysourcecountry": "FR",
      "occurcountry": "FR",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "1",
      "serious": "1",
      "seriousnessdeath": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "FR-PFIZER INC-2014070920",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "PFIZER",
        "duplicatenumb": "FR-PFIZER INC-2014070920"
      },
      "primarysource": {
        "reportercountry": "FR",
        "qualification": "3"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "59",
        "patientonsetageunit": "801",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Cardiac arrest",
            "reactionoutcome": "5"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "SOLU-MEDROL",
            "drugauthorizationnumb": "011856",
            "drugstructuredosagenumb": "1",
            "drugstructuredosageunit": "032",
            "drugdosagetext": "1 DF, SINGLE",
            "drugdosageform": "POWDER AND SOLVENT FOR SOLUTION FOR INJECTION",
            "drugadministrationroute": "042",
            "drugindication": "PREMEDICATION",
            "drugstartdateformat": "102",
            "drugstartdate": "20140204",
            "drugenddateformat": "102",
            "drugenddate": "20140204",
            "openfda": {
              "application_number": [
                "NDA011856"
              ],
              "brand_name": [
                "SOLU-MEDROL"
              ],
              "generic_name": [
                "METHYLPREDNISOLONE SODIUM SUCCINATE"
              ],
              "manufacturer_name": [
                "Pharmacia & Upjohn Company LLC"
              ],
              "product_ndc": [
                "0009-0003",
                "0009-0758",
                "0009-0698",
                "0009-0039",
                "0009-0047",
                "0009-0018",
                "0009-0850"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAMUSCULAR",
                "INTRAVENOUS"
              ],
              "substance_name": [
                "METHYLPREDNISOLONE SODIUM SUCCINATE"
              ],
              "rxcui": [
                "207191",
                "207193",
                "311659",
                "314099",
                "1357886",
                "1357888",
                "1743704",
                "1743707",
                "1743720",
                "1743722",
                "1743726",
                "1743729"
              ],
              "spl_id": [
                "c157d266-8633-4c2e-ae1f-0207e4f19b35",
                "f52c912a-f15e-457a-be68-56dd7f170d6d"
              ],
              "spl_set_id": [
                "cd99be87-c8d9-48d6-a8e5-e081052e3f19",
                "7271310c-7764-4812-aa30-a5e90987c7a9"
              ],
              "package_ndc": [
                "0009-0758-01",
                "0009-0698-01",
                "0009-0039-30",
                "0009-0039-28",
                "0009-0039-33",
                "0009-0039-32",
                "0009-0047-25",
                "0009-0047-22",
                "0009-0047-27",
                "0009-0047-26",
                "0009-0003-02",
                "0009-0018-20",
                "0009-0850-01",
                "0009-0698-02",
                "0009-0039-06",
                "0009-0047-04"
              ],
              "unii": [
                "LEC9GKY20K"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "ERBITUX",
            "drugstructuredosagenumb": "840",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "840 MG, CYCLIC (2 CYCLES)",
            "drugdosageform": "SOLUTION FOR INFUSION",
            "drugadministrationroute": "042",
            "drugindication": "COLON CANCER METASTATIC",
            "drugstartdateformat": "102",
            "drugstartdate": "20140120",
            "drugenddateformat": "102",
            "drugenddate": "20140204",
            "openfda": {
              "application_number": [
                "BLA125084"
              ],
              "brand_name": [
                "ERBITUX"
              ],
              "generic_name": [
                "CETUXIMAB"
              ],
              "manufacturer_name": [
                "ImClone LLC"
              ],
              "product_ndc": [
                "66733-948",
                "66733-958"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "CETUXIMAB"
              ],
              "rxcui": [
                "1657658",
                "1657660",
                "1657663",
                "1657664"
              ],
              "spl_id": [
                "1cd448bd-5230-450c-ad4c-359e6d54cd2b"
              ],
              "spl_set_id": [
                "8bc6397e-4bd8-4d37-a007-a327e4da34d9"
              ],
              "package_ndc": [
                "66733-948-23",
                "66733-958-23"
              ],
              "nui": [
                "N0000175664",
                "N0000020010"
              ],
              "pharm_class_epc": [
                "Epidermal Growth Factor Receptor Antagonist [EPC]"
              ],
              "pharm_class_moa": [
                "HER1 Antagonists [MoA]"
              ],
              "unii": [
                "PQX0D8J21J"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "OXALIPLATIN ACCORD",
            "drugstructuredosagenumb": "145",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "145 MG, CYCLIC (2 CYCLES)",
            "drugdosageform": "CONCENTRATE FOR SOLUTION FOR INFUSION",
            "drugadministrationroute": "042",
            "drugindication": "COLON CANCER METASTATIC",
            "drugstartdateformat": "102",
            "drugstartdate": "20140120",
            "drugenddateformat": "102",
            "drugenddate": "20140204"
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "ONDANSETRON",
            "drugstructuredosagenumb": "8",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "8 MG, SINGLE",
            "drugadministrationroute": "042",
            "drugindication": "PREMEDICATION",
            "drugstartdateformat": "102",
            "drugstartdate": "20140204",
            "drugenddateformat": "102",
            "drugenddate": "20140204",
            "openfda": {
              "application_number": [
                "ANDA076183",
                "ANDA078152",
                "ANDA206846",
                "ANDA090648",
                "ANDA079224",
                "ANDA078776",
                "ANDA077548",
                "ANDA076972",
                "ANDA076974",
                "ANDA091483",
                "ANDA078127",
                "ANDA090469",
                "ANDA077851",
                "ANDA078539",
                "ANDA202253",
                "ANDA077406",
                "ANDA077535",
                "ANDA077541",
                "ANDA077365",
                "ANDA203711",
                "ANDA077303",
                "ANDA077009",
                "ANDA076781",
                "ANDA076780",
                "ANDA202600",
                "ANDA202599",
                "ANDA209389",
                "ANDA077473",
                "ANDA077557"
              ],
              "brand_name": [
                "ONDANSETRON"
              ],
              "generic_name": [
                "ONDANSETRON HYDROCHLORIDE",
                "ONDANSETRON",
                "ONDANSETRON TABLETS"
              ],
              "manufacturer_name": [
                "Dr. Reddy's Laboratories Limited",
                "AvKARE",
                "Accord Healthcare, Inc.",
                "JVET PHARMACEUTICALS LLC",
                "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
                "NorthStar Rx LLC",
                "Hospira, Inc.",
                "Fosun Pharma USA Inc.",
                "Fresenius Kabi USA, LLC",
                "AvPAK",
                "PAI Holdings, LLC dba PAI Pharma",
                "Rising Pharma Holdings, Inc.",
                "Gland Pharma Limited",
                "Natco Pharma Limited",
                "Chartwell RX, LLC",
                "Glenmark Pharmaceuticals Inc., USA",
                "Natco Pharma USA LLC",
                "Hikma Pharmaceuticals USA Inc.",
                "Lifsa Drugs LLC",
                "Sagent Pharmaceuticals",
                "Qilu Pharmaceutical Co., Ltd.",
                "Civica, Inc.",
                "Taro Pharmaceuticals U.S.A., Inc.",
                "West-Ward Pharmaceuticals Corp",
                "Eugia US LLC",
                "Ipca Laboratories Limited",
                "Apotex Corp.",
                "Sun Pharmaceutical Industries, Inc.",
                "Aurobindo Pharma Limited",
                "BluePoint Laboratories",
                "Amneal Pharmaceuticals LLC",
                "Golden State Medical Supply, Inc."
              ],
              "product_ndc": [
                "55111-153",
                "55111-154",
                "55111-156",
                "42291-457",
                "42291-458",
                "16729-298",
                "86211-115",
                "23155-547",
                "23155-549",
                "16714-671",
                "0409-0009",
                "72266-123",
                "72266-124",
                "63323-373",
                "63323-374",
                "50268-647",
                "0121-0882",
                "57237-077",
                "57237-078",
                "65219-323",
                "16714-200",
                "16714-201",
                "68083-114",
                "63850-0003",
                "63850-0004",
                "16714-159",
                "16714-160",
                "76045-103",
                "76045-216",
                "62135-121",
                "62135-122",
                "62135-878",
                "62135-879",
                "68462-105",
                "68462-106",
                "68462-157",
                "68462-158",
                "69339-171",
                "69339-172",
                "0641-6078",
                "0641-6079",
                "72336-073",
                "25021-777",
                "67184-0507",
                "72572-520",
                "62135-350",
                "62135-351",
                "51672-4091",
                "0143-9890",
                "0143-9891",
                "0409-2271",
                "55150-125",
                "55150-126",
                "83980-012",
                "83980-013",
                "23155-548",
                "23155-550",
                "0641-6080",
                "0641-6286",
                "60505-6130",
                "63304-458",
                "63304-459",
                "0409-4755",
                "0409-4759",
                "65862-390",
                "65862-391",
                "68001-246",
                "68001-247",
                "65162-691",
                "51407-003",
                "51407-004",
                "65862-208",
                "68083-113",
                "62756-240",
                "62756-130",
                "62756-131",
                "62756-356"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL",
                "INTRAMUSCULAR",
                "INTRAVENOUS"
              ],
              "substance_name": [
                "ONDANSETRON HYDROCHLORIDE",
                "ONDANSETRON"
              ],
              "rxcui": [
                "198052",
                "312084",
                "312086",
                "104894",
                "312087",
                "283504",
                "1740467",
                "312085",
                "1314133",
                "2685489",
                "2685613"
              ],
              "spl_id": [
                "b5be4b6c-42cd-c9b3-a0df-e15c946ec89b",
                "43cb3193-0685-d065-e063-6394a90afd47",
                "424e0911-305e-8eb5-e063-6294a90aaab3",
                "adb0171f-4da2-4c95-857b-63d172d10a48",
                "a9ae0d2e-667a-4c29-8697-32b044725d35",
                "add9275d-a837-48f4-ab0b-01fc50e4545f",
                "f657416c-88be-4eec-a285-3d2ca82e5c05",
                "3f2b4281-55ef-43e3-e063-6294a90a56ba",
                "83824969-e116-40d6-8940-ff134a4f16c0",
                "47fb3120-1cb0-55b8-e063-6394a90a662a",
                "4aa77c21-9d0a-4d33-ace6-0be0a64a1f15",
                "49380e9c-090e-44fd-b2c9-992e25e26753",
                "0b0b9b52-bc7d-4c4e-8df5-6c9ab0b268d5",
                "952aa289-4c91-49b8-aad8-610855b0a6e1",
                "2f33d54b-c852-4bca-ab80-a2852c1be9b8",
                "04819dac-e9c5-4d65-b8e4-15a1fd5a93c8",
                "9e8d8ea3-cbef-49ef-bcda-3ae6b9ea68d1",
                "b71a45e3-2b90-4199-b88b-fef27cb394fc",
                "1ba47f65-782d-bcae-e063-6294a90a39a5",
                "32177a6a-8c35-4e1c-b7f5-7376b1c1316a",
                "8bc7e584-a388-43b6-9627-e58b7b79b2d1",
                "9e948e67-37a3-48ca-ae91-a73efea950aa",
                "1540d100-da32-4a84-98d9-a9088d2628ea",
                "dbbafc2b-987e-421b-bcfc-d4706859420e",
                "cd294344-e9fc-4b11-811f-0a8843db3227",
                "0c34b5a6-e21b-41e7-8e7b-61a9706b67e0",
                "06fce9d8-ee18-4486-e063-6394a90aeeb4",
                "e10032ef-6d48-44cb-9b7f-9a338f35ca51",
                "7dd1fe92-e406-4dde-a0e7-abfc496ccfc3",
                "e0862c02-781f-4b10-ae50-9c9c4ca26f6d",
                "344b6a95-a41f-4ef0-8434-623257a5f9c5",
                "3582cf26-d9a0-4b93-93a1-d1824e55fc19",
                "13c479ff-8168-4358-b65c-3b320691494c",
                "4936a082-34d2-4cd3-9740-3a55ac939b2e",
                "96665be2-8af7-4ee7-89f4-bdceb16913a7",
                "ad113c32-f57c-4548-9882-c46b9a990bd8",
                "f4d4b538-f4fd-49d7-ac02-b72d48c52e59",
                "aab5d8ee-a492-4deb-b240-62b1b0eb0aa8",
                "4c462efc-fa5d-642d-e063-6294a90a5b72",
                "7421d60d-7d82-4ec5-885a-255c507c32a4",
                "49684d71-7db8-3561-e063-6394a90a2def",
                "a839599f-f788-4039-9e34-b443d1c9849b",
                "89f78024-73fc-4243-a6d1-ae463b613b8c",
                "e83d90db-54a7-4c13-bd68-b1620a8aecaf"
              ],
              "spl_set_id": [
                "162f2088-9fb1-47e7-b88c-45104be7e7bb",
                "352de988-d166-c2d8-e063-6294a90acc01",
                "35e0d160-813f-41d7-a382-d2cab6485d9c",
                "95ca0d81-a0a8-441d-820e-cb6624018a15",
                "b746d4db-43e6-4219-9e6b-f53e59581305",
                "ac3dfb81-a4c7-4147-9374-c234153b7c51",
                "d62cd60b-f87e-4825-bead-1d18bbc4e480",
                "e3f22b7e-b6ad-4799-93c7-d30540cada85",
                "e0050959-c14c-41b6-9a92-fadc5f6feff3",
                "05cf8d4f-ac57-4177-e063-6394a90ae804",
                "68a4d845-0c1c-4867-bfca-c0fb11dc93cd",
                "eb74425c-c635-4d99-8e98-e63e7359fb89",
                "6a231919-6837-4b09-b66d-3706432b9702",
                "281e4296-1d0e-4602-9912-2685ba1640f6",
                "35716914-ac73-43c0-9aa0-09c99211d941",
                "59c817b7-a1c6-48a5-9bfc-2c381532bfd9",
                "9d5e7650-95be-4b96-b29c-374f673eb7a1",
                "d89017aa-b8c3-4fd2-8e68-44e2cfd6f290",
                "4c74336c-11ec-420a-80e1-d8e4a8f1c46d",
                "eee5217a-eba8-463a-812d-bf3c66f0934f",
                "64527de5-0b92-4340-9243-7a37e8ff96d9",
                "c29ca6df-621d-44b6-98fc-b48666573366",
                "c66d63cf-a0e5-4cb5-bdf8-9d1115cba23e",
                "ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7",
                "5e09e262-dadf-4ae0-825e-448ea8dac174",
                "70437694-0341-4f3b-824c-06843403443f",
                "88b7432b-f5a7-40f3-9b0c-e7b125f5103c",
                "a95ca4f4-c4de-4822-9a08-209d10bf5136",
                "bb4bc810-db26-471b-9ce7-6e2fb3018af0",
                "e0862c02-781f-4b10-ae50-9c9c4ca26f6d",
                "1cc94c7a-617c-4238-8248-e3fabc9612c7",
                "8e24f935-87fe-4b6a-b265-60b1039f38d5",
                "8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08",
                "97713356-f42b-4a67-95f6-561afa68c0c2",
                "2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a",
                "834bc56a-657d-4733-9a60-47040cb5c7bf",
                "6a11f61b-2318-4382-2b91-4366e4bb53fa",
                "cab63f24-8728-4927-aba5-53e8d2e44cdb",
                "ed1132ec-c2cd-4646-b69d-26663bb937a4",
                "38435346-d505-4bdd-bbc6-a7bcba411033",
                "2b9ea1fc-59a4-8189-e063-6394a90a9ae6",
                "cf10d256-dd89-4a91-a3ed-81db505a79c2",
                "3efa5604-96c3-42a0-8e99-b3de4a66aa92",
                "92c758a3-e749-4a15-be4b-ee30b364b2b0"
              ],
              "package_ndc": [
                "55111-153-30",
                "55111-153-01",
                "55111-153-05",
                "55111-153-78",
                "55111-153-13",
                "55111-154-30",
                "55111-154-01",
                "55111-154-05",
                "55111-154-79",
                "55111-154-78",
                "55111-154-13",
                "55111-156-30",
                "55111-156-05",
                "55111-156-79",
                "55111-156-78",
                "55111-156-11",
                "42291-457-30",
                "42291-458-30",
                "16729-298-05",
                "86211-115-01",
                "23155-547-31",
                "23155-547-41",
                "23155-547-42",
                "23155-549-31",
                "16714-671-02",
                "16714-671-01",
                "0409-0009-02",
                "0409-0009-25",
                "72266-123-01",
                "72266-123-25",
                "72266-124-01",
                "63323-373-00",
                "63323-373-02",
                "63323-374-20",
                "50268-647-11",
                "50268-647-14",
                "0121-0882-51",
                "57237-077-30",
                "57237-077-01",
                "57237-077-50",
                "57237-077-10",
                "57237-078-30",
                "57237-078-01",
                "57237-078-50",
                "57237-078-10",
                "65219-323-00",
                "65219-323-02",
                "16714-200-10",
                "16714-200-30",
                "16714-201-10",
                "16714-201-30",
                "68083-114-01",
                "63850-0003-1",
                "63850-0004-1",
                "16714-159-01",
                "16714-160-01",
                "76045-103-00",
                "76045-103-20",
                "76045-216-00",
                "76045-216-20",
                "62135-121-30",
                "62135-122-30",
                "62135-878-30",
                "62135-879-30",
                "68462-105-33",
                "68462-105-30",
                "68462-106-33",
                "68462-106-30",
                "68462-157-13",
                "68462-158-11",
                "68462-158-13",
                "69339-171-03",
                "69339-171-01",
                "69339-171-05",
                "69339-172-03",
                "69339-172-01",
                "69339-172-05",
                "0641-6078-01",
                "0641-6078-25",
                "0641-6079-01",
                "72336-073-30",
                "25021-777-02",
                "67184-0507-5",
                "72572-520-01",
                "72572-520-25",
                "62135-350-30",
                "62135-350-05",
                "62135-351-30",
                "62135-351-05",
                "51672-4091-3",
                "0143-9890-01",
                "0143-9890-10",
                "0143-9891-01",
                "0143-9891-25",
                "0409-2271-02",
                "0409-2271-25",
                "55150-126-20",
                "55150-125-02",
                "83980-012-13",
                "83980-012-01",
                "83980-012-10",
                "83980-012-83",
                "83980-013-13",
                "83980-013-01",
                "83980-013-10",
                "83980-013-83",
                "23155-548-31",
                "23155-548-41",
                "23155-548-42",
                "23155-550-31",
                "0641-6080-01",
                "0641-6080-25",
                "0641-6286-01",
                "60505-6130-0",
                "60505-6130-5",
                "63304-458-30",
                "63304-459-30",
                "0409-4755-18",
                "0409-4755-03",
                "0409-4759-01",
                "65862-390-30",
                "65862-390-02",
                "65862-390-05",
                "65862-390-19",
                "65862-390-10",
                "65862-391-30",
                "65862-391-02",
                "65862-391-05",
                "65862-391-66",
                "65862-391-01",
                "65862-391-10",
                "68001-246-16",
                "68001-246-17",
                "68001-246-04",
                "68001-247-16",
                "68001-247-01",
                "68001-247-17",
                "68001-247-55",
                "68001-247-04",
                "65162-691-79",
                "65162-691-37",
                "65162-691-19",
                "51407-003-30",
                "51407-003-05",
                "51407-004-30",
                "51407-004-05",
                "65862-208-50",
                "65862-208-04",
                "68083-113-01",
                "62756-130-02",
                "62756-130-01",
                "62756-131-02",
                "62756-131-01",
                "62756-240-64",
                "62756-240-83",
                "62756-356-64",
                "62756-356-83",
                "62756-356-66"
              ],
              "unii": [
                "NMH84OZK2B",
                "4AF302ESOS"
              ],
              "nui": [
                "N0000175817",
                "N0000175818"
              ],
              "pharm_class_moa": [
                "Serotonin 3 Receptor Antagonists [MoA]"
              ],
              "pharm_class_epc": [
                "Serotonin-3 Receptor Antagonist [EPC]"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "POLARAMINE",
            "drugstructuredosagenumb": "5",
            "drugstructuredosageunit": "003",
            "drugdosagetext": "5 MG, SINGLE",
            "drugdosageform": "SOLUTION FOR INJECTION",
            "drugadministrationroute": "042",
            "drugindication": "PREMEDICATION",
            "drugstartdateformat": "102",
            "drugstartdate": "20140204",
            "drugenddateformat": "102",
            "drugenddate": "20140204"
          }
        ]
      }
    }
  ]
}