Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10137246primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received29/04/2014receiptdateformat102Date Last Updated29/04/2014fulfillexpeditecriteria2companynumbUS-ABBVIE-14P-163-1213506-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1213506-00

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age80Unit of Onset AgeyearsWeight79.45SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDysphoniaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionApplication site paraesthesiaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionHeart rate increasedOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionVasodilatationOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionContusionOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductANDROGELdrugbatchnumb90387drugauthorizationnumb022309drugstructuredosagenumb20.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PUMP DAILYdrugdosageformGELdrugadministrationroute061drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat610drugstartdate/12/2013drugenddateformat610drugenddate/01/2014actiondrug1

openFDA Info on Medication

Application NumberNDA022309, NDA021015Brand NameANDROGELGeneric NameTESTOSTERONEManufacturersAbbVie Inc.product_ndc0051-8462, 0051-8425, 0051-8488, 0051-8450Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsTESTOSTERONERXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597074, 1597123, ... spl_idd34e7ee8-3f6b-4473-8e1b-f3a90467fb6c, 2e54dd8d-cf81-4c69-ad15-fa24f47dd3daspl_set_id8677ba5b-8374-46cb-854c-403972e9ddf3, c506aaa3-04f8-4eb1-8dc4-e964cdd08e7fPackage NDC 0051-8462-33, 0051-8462-12, 0051-8462-31, 0051-8462-01, 0051-8462-30, 0051-8488- ... NUIN0000175824, N0000000146, M0001109Established Pharmacologic ClassAndrogen [EPC]Mechanism of ActionAndrogen Receptor Agonists [MoA]Chemical StructureAndrostanes [CS]UNII3XMK78S47O

2)

drugcharacterization2medicinalproductMETHOTREXATEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA209787, ANDA040632, ANDA201749, ANDA08123 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Alvogen Inc., ... product_ndc 61703-350, 61703-408, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, ORAL, INTRA-ARTERIALActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1655956, 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595 ... spl_id e7f451fd-9103-459a-8a81-115f1fc1077c, 17840925-09d5-493f-90ba-f2082d625a86, d2bf ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

3)

drugcharacterization2medicinalproductPREDNISONEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

4)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

5)

drugcharacterization2medicinalproductCLONAZEPAMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

6)

drugcharacterization2medicinalproductNEXIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

7)

drugcharacterization2medicinalproductZANTACdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

8)

drugcharacterization2medicinalproductATENOLOLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA073457, ANDA07405 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 1b1cbfbf-b6bc-d1f8-d245-c6c68cda33f3, 5d59c0f7-9ff3-4dff-96b6-da6ebe996a8e, 29c4 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

9)

drugcharacterization2medicinalproductTOVIAZdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA022030Brand NameTOVIAZGeneric NameFESOTERODINE FUMARATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-183, 63539-242, 0069-0242, 0069-0244Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFESOTERODINE FUMARATERXCUI810071, 810075, 810077, 810079spl_id778882a1-fb9a-4405-96f9-18ea583085d3, e5663b6d-f2fb-4836-a859-f15b34353584spl_set_id4f01dced-195a-4712-a614-d68012bc29df, 5be745f0-8ae7-4c3c-9962-37d6263326f1Package NDC63539-242-77, 63539-183-77, 0069-0242-30, 0069-0244-30UNIIEOS72165S7

10)

drugcharacterization2medicinalproductPROBIOTICSdrugindicationPRODUCT USED FOR UNKNOWN INDICATION