{ "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": 10, "total": 19115 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10555873", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150529", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20141030", "receiptdateformat": "102", "receiptdate": "20141030", "fulfillexpeditecriteria": "1", "companynumb": "US-GILEAD-2014-0120484", "duplicate": "1", "reportduplicate": { "duplicatesource": "GILEAD", "duplicatenumb": "US-GILEAD-2014-0120484" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "70", "patientonsetageunit": "801", "patientagegroup": "6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Swelling face", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "PLANT FUSION WITH PROTEIN POWDER" }, { "drugcharacterization": "2", "medicinalproduct": "SEA VEG" }, { "drugcharacterization": "2", "medicinalproduct": "VIBRANCE GREEN" }, { "drugcharacterization": "1", "medicinalproduct": "HARVONI", "drugauthorizationnumb": "205834", "drugdosagetext": "UNK", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead 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"safetyreportversion": "2", "safetyreportid": "10564309", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20141104", "receiptdateformat": "102", "receiptdate": "20150414", "fulfillexpeditecriteria": "1", "companynumb": "US-GILEAD-2014-0120470", "duplicate": "1", "reportduplicate": { "duplicatesource": "GILEAD", "duplicatenumb": "US-GILEAD-2014-0120470" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "60", "patientonsetageunit": "801", "patientagegroup": "5", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Dyspepsia", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HARVONI", "drugauthorizationnumb": "205834", "drugdosagetext": "UNK", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "HEPATITIS C", "drugstartdateformat": "102", "drugstartdate": "20141023", "actiondrug": "5", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-1801", "61958-1803", "61958-1805", "61958-1804" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEDIPASVIR", "SOFOSBUVIR" ], "rxcui": [ "1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104" ], "spl_id": [ "6fc15183-879a-4402-af66-edf57754e31f" ], "spl_set_id": [ "f4ec77e4-bae8-4db0-b3d5-bde09c5fa075" ], "package_ndc": [ "61958-1801-1", "61958-1803-1", "61958-1805-1", "61958-1804-1" ], "nui": [ "N0000191256", "N0000185503", "N0000190113", "N0000191493", "N0000191258" ], "pharm_class_epc": [ "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]" ], "pharm_class_moa": [ "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]" ], "unii": [ "013TE6E4WV", "WJ6CA3ZU8B" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10567735", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150529", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20141105", "receiptdateformat": "102", "receiptdate": "20141105", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "49", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Diarrhoea" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HARVONI", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "BY MOUTH", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CHRONIC HEPATITIS C", "drugstartdateformat": "102", "drugstartdate": "20141028", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-1801", "61958-1803", "61958-1805", "61958-1804" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEDIPASVIR", "SOFOSBUVIR" ], "rxcui": [ "1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104" ], "spl_id": [ "6fc15183-879a-4402-af66-edf57754e31f" ], "spl_set_id": [ "f4ec77e4-bae8-4db0-b3d5-bde09c5fa075" ], "package_ndc": [ "61958-1801-1", "61958-1803-1", "61958-1805-1", "61958-1804-1" ], "nui": [ "N0000191256", "N0000185503", "N0000190113", "N0000191493", "N0000191258" ], "pharm_class_epc": [ "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]" ], "pharm_class_moa": [ "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]" ], "unii": [ "013TE6E4WV", "WJ6CA3ZU8B" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20141103" } } }, { "safetyreportversion": "1", "safetyreportid": "10569133", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150529", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20141106", "receiptdateformat": "102", "receiptdate": "20141106", "fulfillexpeditecriteria": "1", "companynumb": "US-GILEAD-2014-0121190", "duplicate": "1", "reportduplicate": { "duplicatesource": "GILEAD", "duplicatenumb": "US-GILEAD-2014-0121190" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Gastrointestinal motility disorder", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HARVONI", "drugauthorizationnumb": "205834", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-1801", "61958-1803", "61958-1805", "61958-1804" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEDIPASVIR", "SOFOSBUVIR" ], "rxcui": [ "1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104" ], "spl_id": [ "6fc15183-879a-4402-af66-edf57754e31f" ], "spl_set_id": [ "f4ec77e4-bae8-4db0-b3d5-bde09c5fa075" ], "package_ndc": [ "61958-1801-1", "61958-1803-1", "61958-1805-1", "61958-1804-1" ], "nui": [ "N0000191256", "N0000185503", "N0000190113", "N0000191493", "N0000191258" ], "pharm_class_epc": [ "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]" ], "pharm_class_moa": [ "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]" ], "unii": [ "013TE6E4WV", "WJ6CA3ZU8B" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10574244", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150529", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20141110", "receiptdateformat": "102", "receiptdate": "20141110", "fulfillexpeditecriteria": "1", "companynumb": "US-GILEAD-2014-0121768", "duplicate": "1", "reportduplicate": { "duplicatesource": "GILEAD", "duplicatenumb": "US-GILEAD-2014-0121768" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "61", "patientonsetageunit": "801", "patientagegroup": "5", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Erythema", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pruritus", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HARVONI", "drugauthorizationnumb": "205834", "drugdosagetext": "UNK", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20141029", "actiondrug": "4", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-1801", "61958-1803", "61958-1805", "61958-1804" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEDIPASVIR", "SOFOSBUVIR" ], "rxcui": [ "1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104" ], "spl_id": [ "6fc15183-879a-4402-af66-edf57754e31f" ], "spl_set_id": [ "f4ec77e4-bae8-4db0-b3d5-bde09c5fa075" ], "package_ndc": [ "61958-1801-1", "61958-1803-1", "61958-1805-1", "61958-1804-1" ], "nui": [ "N0000191256", "N0000185503", "N0000190113", "N0000191493", "N0000191258" ], "pharm_class_epc": [ "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]" ], "pharm_class_moa": [ "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]" ], "unii": [ "013TE6E4WV", "WJ6CA3ZU8B" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201411" } } }, { "safetyreportversion": "1", "safetyreportid": "10574606", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150529", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20141110", "receiptdateformat": "102", "receiptdate": "20141110", 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"drugauthorizationnumb": "205834", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-1801", "61958-1803", "61958-1805", "61958-1804" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEDIPASVIR", "SOFOSBUVIR" ], "rxcui": [ "1591943", "1591949", "2203895", "2203897", "2204100", "2204102", "2204103", "2204104" ], "spl_id": [ "6fc15183-879a-4402-af66-edf57754e31f" ], "spl_set_id": [ "f4ec77e4-bae8-4db0-b3d5-bde09c5fa075" ], "package_ndc": [ "61958-1801-1", "61958-1803-1", "61958-1805-1", "61958-1804-1" ], "nui": [ "N0000191256", "N0000185503", "N0000190113", "N0000191493", 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"receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "45.35", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Headache", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HARVONI", "drugauthorizationnumb": "205834", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "HEPATITIS C", "actiondrug": "5", "activesubstance": { "activesubstancename": "LEDIPASVIR\\SOFOSBUVIR" }, "openfda": { "application_number": [ "NDA205834", "NDA212477" ], "brand_name": [ "HARVONI" ], "generic_name": [ "LEDIPASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-1801", "61958-1803", "61958-1805", "61958-1804" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEDIPASVIR", "SOFOSBUVIR" ], "rxcui": [ "1591943", "1591949", "2203895", "2203897", "2204100", "2204102", 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Sciences, Inc" ], "product_ndc": [ "61958-0701", "61958-0703", "61958-0704", "61958-0705" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMTRICITABINE", "TENOFOVIR DISOPROXIL FUMARATE" ], "rxcui": [ "476556", "639888", "1744001", "1744003", "1744005", "1744007", "1744009", "1744011" ], "spl_id": [ "32422ee8-1cdc-4305-bb3e-0458472513fc" ], "spl_set_id": [ "54e82b13-a037-49ed-b4b3-030b37c0ecdd" ], "package_ndc": [ "61958-0701-1", "61958-0703-1", "61958-0704-1", "61958-0705-1" ], "nui": [ "N0000175462", "M0015066", "N0000009947" ], "pharm_class_epc": [ "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]" ], "pharm_class_cs": [ "Nucleosides [CS]" ], "pharm_class_moa": [ "Nucleoside Reverse Transcriptase Inhibitors [MoA]" ], "unii": [ "OTT9J7900I", "G70B4ETF4S" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TIVICAY", "activesubstance": { "activesubstancename": "DOLUTEGRAVIR SODIUM" }, "openfda": { 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