Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11473814primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received08/09/2015receiptdateformat102Date Last Updated08/09/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsWeight68.04SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionHeadache

2)

reactionmeddraversionpt18.1ReactionNeck pain

3)

reactionmeddraversionpt18.1ReactionStaphylococcal infection

4)

reactionmeddraversionpt18.1ReactionSwelling

5)

reactionmeddraversionpt18.1ReactionNausea

6)

reactionmeddraversionpt18.1ReactionEar infection

7)

reactionmeddraversionpt18.1ReactionDecreased appetite

8)

reactionmeddraversionpt18.1ReactionDepression

9)

reactionmeddraversionpt18.1ReactionFatigue

10)

reactionmeddraversionpt18.1ReactionMuscle spasms

11)

reactionmeddraversionpt18.1ReactionPain

12)

reactionmeddraversionpt18.1ReactionVocal cord disorder

13)

reactionmeddraversionpt18.1ReactionVomiting

14)

reactionmeddraversionpt18.1ReactionDiarrhoea

15)

reactionmeddraversionpt18.1ReactionGastrooesophageal reflux disease

16)

reactionmeddraversionpt18.1ReactionPruritus

17)

reactionmeddraversionpt18.1ReactionSinusitis

Drug

1)

drugcharacterization1medicinalproductRIBAVIRIN ZYDUS PHARMACEUTICALdrugbatchnumbMP7974drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext200 MG, 5 DAILYdrugadministrationroute048

activesubstance

activesubstancenameRIBAVIRIN

2)

drugcharacterization2medicinalproductMAGDELAY

3)

drugcharacterization2medicinalproductOMEPRAZOLE.

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

4)

drugcharacterization1medicinalproductHARVONIdrugbatchnumb003445Adrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext90/400 MGdrugadministrationroute048drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate15/05/2015drugenddateformat102drugenddate05/08/2015drugadditional2

activesubstance

activesubstancenameLEDIPASVIR\SOFOSBUVIR

openFDA Info on Medication

Application NumberNDA205834, NDA212477Brand NameHARVONIGeneric NameLEDIPASVIR AND SOFOSBUVIRManufacturersGilead Sciences, Incproduct_ndc61958-1801, 61958-1803, 61958-1805, 61958-1804Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEDIPASVIR, SOFOSBUVIRRXCUI1591943, 1591949, 2203895, 2203897, 2204100, 2204102, 2204103, 2204104spl_id6122d2f4-19e4-4aae-89ce-bef7bfc5cb3espl_set_idf4ec77e4-bae8-4db0-b3d5-bde09c5fa075Package NDC61958-1801-1, 61958-1803-1, 61958-1805-1, 61958-1804-1NUIN0000191493, N0000191258, N0000191256, N0000185503, N0000190113Established Pharmacologic Class Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], Hepatitis C ... Mechanism of Action RNA Replicase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Breast Cancer R ... UNIIWJ6CA3ZU8B, 013TE6E4WV

5)

drugcharacterization2medicinalproductFAMOTIDINE (PEPCID)

6)

drugcharacterization2medicinalproductALBUTEROL SULFATE.

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application Number ANDA077788, ANDA210948, ANDA074454, NDA020983, ANDA074880, ANDA077839, NDA021457 ... Brand Name ALBUTEROL SULFATE, ALBUTEROL, VENTOLIN HFA, PROAIR HFA, PROVENTIL HFA, PROAIR DI ... Generic NameALBUTEROL SULFATEManufacturers Chartwell RX, LLC, Nivagen Pharmaceuticals Inc, Actavis Pharma, Inc., GlaxoSmith ... product_ndc 62135-189, 75834-273, 75834-274, 0472-0825, 0173-0682, 0487-9501, 0378-8270, 593 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION), INTRABRONCHIALActive IngredientsALBUTEROL SULFATERXCUI 755497, 197316, 197318, 801092, 801095, 859088, 2123076, 630208, 745752, 2123072 ... spl_id e0dda671-10d7-8721-e053-2a95a90a39e2, 5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d129 ... spl_set_id 560df50c-e2c4-459f-9d89-bf7e6588949e, b735e92d-eb1a-6fc1-e053-2995a90afce2, 8bac ... Package NDC 62135-189-41, 62135-189-47, 75834-273-01, 75834-274-01, 0472-0825-16, 0472-0825- ... UNII021SEF3731

7)

drugcharacterization2medicinalproductARIPIPRAZOL (ABILIFY)

8)

drugcharacterization2medicinalproductLACTULOSE.

activesubstance

activesubstancenameLACTULOSE

openFDA Info on Medication

Application Number ANDA074076, ANDA074623, ANDA074712, ANDA090503, ANDA203762, ANDA207786, ANDA0759 ... Brand NameLACTULOSE, KRISTALOSE, CONSTULOSE, ENULOSE, GENERLACGeneric NameLACTULOSEManufacturers Akorn, Pharmaceutical Associates, Inc,, Cumberland Pharmaceuticals Inc., Actavis ... product_ndc 50383-779, 0121-0577, 0121-4577, 0121-1154, 66220-719, 66220-729, 45963-439, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RECTALActive IngredientsLACTULOSERXCUI391937, 1251190, 1251192, 1251194, 1251196, 544452, 755470, 544455spl_id 80e580f9-6195-4356-af70-9920e8a0939e, bfdf8c6c-b882-1e52-e053-2a95a90a284a, 22d5 ... spl_set_id 19455240-16b6-4e25-a5c9-a6c965e5ec19, 0f19e4ed-c90a-4330-a7fa-bf911aa98f09, 535d ... Package NDC 50383-779-15, 50383-779-17, 50383-779-30, 50383-779-31, 50383-779-33, 50383-779- ... NUIN0000175811, N0000010288, N0000175833, N0000009871Established Pharmacologic ClassOsmotic Laxative [EPC]Mechanism of ActionOsmotic Activity [MoA], Acidifying Activity [MoA]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNII9U7D5QH5AE

9)

drugcharacterization2medicinalproductMETFORMIN

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

10)

drugcharacterization2medicinalproductHYDROMORPHONE

activesubstance

activesubstancenameHYDROMORPHONE

11)

drugcharacterization2medicinalproductSPIRONOLACTONE.

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, ANDA202187, ANDA089424, ANDA2059 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, c2d4 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

12)

drugcharacterization2medicinalproductXIFAXEN (RIFAXIMIN)

13)

drugcharacterization2medicinalproductACYCLOVIR.

activesubstance

activesubstancenameACYCLOVIR

openFDA Info on Medication

Application Number ANDA206535, ANDA205469, ANDA203834, ANDA208702, ANDA205510, NDA018604, ANDA20245 ... Brand NameACYCLOVIR, ACYCLOVIX, SITAVIG, ZOVIRAXGeneric NameACYCLOVIR, ACYCLOVIR SODIUMManufacturers Zydus Pharmaceuticals (USA) Inc., Taro Pharmaceuticals U.S.A., Inc., Camber Phar ... product_ndc 68382-048, 68382-049, 51672-1360, 31722-777, 31722-778, 45802-044, 16714-885, 05 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, TOPICAL, ORAL, CUTANEOUS, BUCCALActive IngredientsACYCLOVIR SODIUM, ACYCLOVIRRXCUI 1734932, 1734934, 197312, 197311, 197313, 141859, 197310, 307730, 2263503, 22635 ... spl_id 515388e8-636f-42f6-a39e-bb4fc7c2e7cb, 318fdb7d-10d9-49cf-bbd1-0a7480b962d9, bf4d ... spl_set_id 69a98000-adef-4323-89a7-09e035a257d4, 962b2e1a-ba9d-4b39-b6d1-203947166482, 0910 ... Package NDC 68382-048-01, 68382-048-10, 68382-049-01, 68382-049-10, 51672-1360-1, 51672-1360 ... UNII927L42J563, X4HES1O11FNUIN0000020060, N0000180187, N0000180188, N0000175468, N0000175459Mechanism of ActionDNA Polymerase Inhibitors [MoA]Established Pharmacologic Class Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zo ...

14)

drugcharacterization2medicinalproductFAMICLOVIR

15)

drugcharacterization2medicinalproductVENLAFAXINE HCL

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

16)

drugcharacterization2medicinalproductADDERALL

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHA ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_id12989a25-f31c-4550-9b5d-f354f7f0af45, e3546445-6a4a-46a2-af40-026167005259spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNIIJJ768O327N, O1ZPV620O4, G83415V073, 6DPV8NK46S

17)

drugcharacterization2medicinalproductLEVOTHYROXINE.

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

18)

drugcharacterization2medicinalproductASCORBIC ACID.

activesubstance

activesubstancenameASCORBIC ACID

openFDA Info on Medication

Brand NameASCORBIC ACID, ASCOR, ASCORBIC ACID 1505, AROMACURA SHOWER FILTERGeneric NameASCORBIC ACIDManufacturers Deseret Biologicals, Inc., McGuff Pharmaceuticals, Inc., Professional Complement ... product_ndc43742-0561, 67157-101, 63083-1505, 72832-0010Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, TOPICALActive IngredientsASCORBIC ACIDspl_id b11b2d5b-fc71-4d20-acaa-36a10dafc6aa, dd1c07e1-fb4b-dec7-e053-2995a90a73f4, 1efe ... spl_set_id 2921d70b-834f-4eb9-abc3-6e9438c3167f, 388aad52-fc01-4784-9791-1dbc80c69306, 38ad ... Package NDC43742-0561-1, 67157-101-50, 67157-101-51, 63083-1505-1, 72832-0010-1NUIN0000193618, M0001797Established Pharmacologic ClassVitamin C [EPC]Chemical StructureAscorbic Acid [CS]UNIIPQ6CK8PD0RApplication NumberNDA209112RXCUI308395, 2002739

19)

drugcharacterization2medicinalproductCALCIUM AND VIT D

activesubstance

activesubstancenameCALCIUM\VITAMIN D

20)

drugcharacterization2medicinalproductLASIX

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

21)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

22)

drugcharacterization2medicinalproductWELLBUTRIN

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25, eb423af3-e5f0-4c6c-a698-ff0ef35edcabspl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

23)

drugcharacterization2medicinalproductCRANBERRY.

activesubstance

activesubstancenameCRANBERRY

24)

drugcharacterization2medicinalproductNADOLOL.

activesubstance

activesubstancenameNADOLOL

openFDA Info on Medication

Application Number ANDA201893, ANDA203455, ANDA208832, ANDA207761, ANDA212856, ANDA210955, NDA01806 ... Brand NameNADOLOL, CORGARDGeneric NameNADOLOLManufacturers Aurobindo Pharma Limited, Cipla USA Inc., Amneal Pharmaceuticals NY LLC, Zydus P ... product_ndc 59651-251, 59651-589, 59651-252, 69097-867, 69097-868, 69097-869, 69238-1123, 69 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNADOLOLRXCUI198006, 198007, 198008, 201337, 201338, 206961spl_id c3af0b07-58ac-4266-bfdb-2a4d9da26c9c, 04cca80e-cd0b-467d-9017-32fe1380e044, 2d5c ... spl_set_id 44c5352d-89f8-4bd3-9479-1069304562ca, c899eedb-4113-45da-acc3-8e181250a7d8, e2e2 ... Package NDC 59651-589-01, 59651-251-01, 59651-252-01, 69097-867-07, 69097-867-15, 69097-867- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNIIFEN504330V

25)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE.

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, POTASSIUM CHLORIDE EXTENDE ... Generic Name POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEX ... Manufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATION, DEXTROSE MONOHYDRATEspl_id d43e4cfe-351c-7369-e053-2995a90ab722, dd7e7134-d695-4776-92ce-8c940715a702, e172 ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-134-01, 31722-135- ... UNII660YQ98I10, 295O53K152, LX22YL083GApplication Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

26)

drugcharacterization2medicinalproductVIT B INJECTION

summary

narrativeincludeclinicalCASE EVENT DATE: 20150515