Paralysis, Peripheral coldness
Drugs: PREDNISONE., TOPIRAMATE., DAIVOBET +2
- Safetyreportversion
- 1
- Safetyreportid
- 11096569
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20150821
- Reporttype
- 1
- Serious
- 2
- Receivedateformat
- 102
- Receivedate
- 20150507
- Receiptdateformat
- 102
- Receiptdate
- 20150507
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-LEO PHARMA-223334
- Duplicate
- 1
- Reportduplicate
- Duplicatesource
- LEO PHARM
- Duplicatenumb
- US-LEO PHARMA-223334
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 2
- Senderorganization
- FDA-Public Use
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 18.0
- Reactionmeddrapt
- Paralysis
- Reactionoutcome
- 1
- Reactionmeddraversionpt
- 18.0
- Reactionmeddrapt
- Peripheral coldness
- Reactionoutcome
- 1
- Drug
- Drugcharacterization
- 2
- Medicinalproduct
- PREDNISONE.
- Drugseparatedosagenumb
- 3
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugadministrationroute
- 048
- Drugindication
- PRODUCT USED FOR UNKNOWN INDICATION
- Activesubstance
- Activesubstancename
- PREDNISONE
- Harmonized identifiers (openFDA)
- Application number
- ANDA215246, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA040581, ANDA040256, ANDA040392, ANDA210785, ANDA218035, ANDA080352, ANDA211495, ANDA215671, ANDA219477, ANDA088703, ANDA084275, ANDA208412, ANDA211496, ANDA213385, ANDA215672, ANDA212629, ANDA213386, ANDA211575, ANDA080356, ANDA085162, ANDA085161
- Brand name
- PREDNISONE, PREDNISONE DELAYED RELEASE, PREDNISONE TABLETS, USP, 5 MG, PREDNISONE TABLETS, USP, 10 MG, PREDNISONE TABLETS, USP, 20 MG
- Generic name
- PREDNISONE
- Manufacturer name
- ANI Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc., Par Health USA, LLC, Strides Pharma Science Limited, Dr. Reddys Laboratories Inc., Hikma Pharmaceuticals USA Inc., Chartwell RX, LLC, Aurobindo Pharma Limited, INA Pharmaceutics Inc, Amneal Pharmaceuticals NY LLC, Granulation Technology, Inc., Actavis Pharma, Inc.
- Product NDC
- 70954-056, 0378-0640, 0378-0641, 0378-0642, 0603-5335, 0603-5336, 0603-5337, 0603-5338, 0603-5339, 64380-782, 43598-888, 0054-9817, 0054-9828, 0054-9818, 62135-471, 59651-484, 74157-010, 74157-019, 0054-0017, 0054-4741, 0054-4742, 0054-4728, 0054-0018, 0054-0019, 0054-3722, 0054-3721, 0054-8739, 0054-8740, 0054-8724, 62135-553, 64380-783, 64380-835, 62135-470, 60219-1705, 60219-1706, 59651-485, 59651-486, 59651-487, 59651-488, 59651-489 +18 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- PREDNISONE
- RxCUI
- 198144, 198145, 312615, 312617, 198146, 763179, 763181, 763183, 763185, 1303135, 1303125, 1303132, 198148, 205301, 315187
- SPL ID
- 08d9d724-eebf-4785-a0ac-95c049bc9488, f7cba7fb-7b9f-4464-a702-5c4f818aeb5f, 68bdeba1-553d-4d18-ae66-5eb8a0a880b8, 675efef2-fa13-42d1-9460-d1e334f78a48, 1da2eb36-ff47-3cf6-e845-67460ced05fb, 249c4c6d-a058-489a-8f84-928c14bfd3f9, 45ae68aa-b969-3d1b-e063-6394a90a0a02, 6f9a9020-efd5-4f7d-90c7-11af33e93793, 463c5b39-7eb2-d396-e063-6394a90aa451, 523ad364-8d95-4679-9290-446d61f36eb5, 04b754a5-5740-f71c-e063-6294a90aef67, c389b525-c68a-43dc-bacc-c75707b391b5, 45ae6dea-506e-55d8-e063-6394a90a0a4c, abdf7308-9460-4e7f-a68a-2fe647e82602, d957f055-4838-49e6-ae32-604fb3056bc4, a9e0d98c-c1bf-62b0-67b3-3b8f8313b408, bdf0b63b-7d6e-4799-be31-cdbf94e02145, 3c696af0-7946-dd78-e063-6394a90a71cc, 34381f6f-1b15-42c8-a8e6-af8302eb6c1e, f662b658-7133-468c-b35a-ed6083cbff91, 6e6cf2e7-c839-4c9f-a58a-fea5023fb432
- SPL set ID
- 7335a293-992b-490c-ab8a-66a7ca1eea30, fec09050-5ac2-451b-a2b9-5a21b2def212, 10fe5a3b-84dc-4600-87c2-b80c97ce18cf, a2c2e8ee-d222-47c5-93c2-8b44160a7e48, 474974ac-9811-c9f5-4050-58e535351d00, 263ed4fa-3c29-4abb-9cb1-bc016bd34a05, 36631112-3abb-4003-886b-9fe6d9cbe2cc, 7b33767f-a520-4470-8f3f-4e86b38d615a, 463c7cd2-c973-5c6c-e063-6394a90a09a0, 3115aef0-fd50-4ec8-a064-3effb695f3f2, 92483276-d55c-42c6-8bbc-27137ff25296, 52010a34-aadb-4561-ac4a-3ee53f5e3566, f532c919-765d-407a-9e01-db2dc0c006f5, 0740ef68-7641-432e-bd46-4710687fc9d7, b1ac4c92-e1fd-4015-b172-0932790ae019, 01bdc479-1f1f-af94-837c-12e7e861321a, 2ef05381-faad-4e0f-b58d-9f2236a04a2c, a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f, 03228706-92b9-43c9-8d73-c73aa124c58d, f05eb734-07e7-491c-b2e9-aae340e03750, aa0b1582-6ef3-4697-9ea6-5391e6e57853
- Package NDC
- 70954-056-10, 70954-056-20, 0378-0640-01, 0378-0640-10, 0378-0641-01, 0378-0641-10, 0378-0642-01, 0378-0642-05, 0378-0642-10, 0603-5335-21, 0603-5335-32, 0603-5336-21, 0603-5337-21, 0603-5337-32, 0603-5337-15, 0603-5337-31, 0603-5338-21, 0603-5338-28, 0603-5338-32, 0603-5338-15, 0603-5338-31, 0603-5339-21, 0603-5339-28, 0603-5339-32, 64380-782-06, 43598-888-01, 43598-888-30, 0054-9828-25, 0054-9828-31, 0054-9817-25, 0054-9817-29, 0054-9818-25, 0054-9818-29, 62135-471-90, 62135-471-18, 59651-484-01, 59651-484-99, 59651-484-78, 74157-010-30, 74157-019-30 +100 more
- Nui
- N0000175576, N0000175450
- Pharm class epc
- Corticosteroid [EPC]
- Pharm class moa
- Corticosteroid Hormone Receptor Agonists [MoA]
- UNII
- VB0R961HZT
- Drugcharacterization
- 2
- Medicinalproduct
- TOPIRAMATE.
- Drugseparatedosagenumb
- 2
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugadministrationroute
- 048
- Drugindication
- PRODUCT USED FOR UNKNOWN INDICATION
- Activesubstance
- Activesubstancename
- TOPIRAMATE
- Harmonized identifiers (openFDA)
- Application number
- ANDA215414, ANDA078235, ANDA217694, ANDA208949, ANDA079162, ANDA217231, ANDA216683, ANDA215449, ANDA205976, NDA020505, NDA020844, NDA205122, ANDA078877, ANDA207382, ANDA218482, ANDA215638, NDA214679, ANDA077627, ANDA078462, ANDA215561, ANDA090278, ANDA217795, ANDA217869, ANDA215663, ANDA206210, ANDA210278, ANDA090162, ANDA076343, ANDA217443
- Brand name
- TOPIRAMATE, TOPAMAX, EPRONTIA, QUDEXY XR
- Generic name
- TOPIRAMATE
- Manufacturer name
- Camber Pharmaceuticals, Inc., Zydus Lifesciences Limited, Quallent Pharmaceuticals Health LLC, Upsher-Smith Laboratories, LLC, XLCare Pharmaceuticals, Inc., Cipla USA Inc., Dr. Reddys Laboratories Inc., Advagen Pharma Ltd, Zydus Pharmaceuticals USA Inc., Aurobindo Pharma Limited, Par Health USA, LLC, Janssen Pharmaceuticals, Inc., Ascend Laboratories, LLC, Vitruvias Therapeutics, Inc., Azurity Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc., USA, Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., EXELAN PHARMACEUTICALS INC., Ajanta Pharma USA Inc., Teva Pharmaceuticals, Inc., Unichem Pharmaceuticals (USA), Inc.
- Product NDC
- 31722-181, 31722-182, 31722-183, 31722-184, 65841-647, 65841-648, 65841-649, 65841-650, 82009-135, 82009-136, 82009-137, 24979-210, 24979-211, 72865-313, 72865-314, 72865-315, 72865-316, 70771-1656, 70771-1657, 70771-1658, 70771-1659, 70771-1660, 69097-816, 69097-817, 69097-818, 69097-819, 43598-939, 43598-940, 43598-941, 43598-942, 72888-228, 72888-229, 72888-230, 68382-138, 68382-139, 68382-140, 68382-141, 59651-452, 59651-453, 10370-365 +98 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- TOPIRAMATE
- RxCUI
- 151226, 199888, 199889, 199890, 205315, 205316, 1494769, 1812419, 1812421, 1812425, 1812427, 1436239, 1437278, 1437283, 1437288, 252413, 151227, 151228, 151229, 152855, 845478, 845479, 2586427, 2586433, 1494766, 1494771, 1494775, 1494778, 1494781
- SPL ID
- 62911647-4208-47b3-a9af-67f026411019, 85c62092-3b8c-43af-a980-e2d959e0c341, b67db755-e8c2-45bd-8954-19dbdf1a77c5, e82bef13-353e-4567-8881-21b797200722, 297988b4-69fb-4691-92e0-ee5da80b0125, 432dc54b-f28b-48c9-b417-2fbae070f41b, 1b47473e-6644-4026-90e5-b169fce62b60, 641acdcc-9618-84e0-a09a-cbf956ffbe61, 4e8dd02d-2263-78d0-e063-6294a90a5f0b, 48ba6ac8-7f36-4a5c-8055-295af6083862, f12f3b94-ddf4-4fe0-ba06-01e4ffad1b71, 3ea04de6-6c56-44ab-ba90-def5e0468ba5, 1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8, 1be5841a-e872-475c-bfe9-859be4ba4001, c45924d5-c45b-4f31-afa5-0cbc090d2816, 709dd70b-24e1-435f-8373-02e6dd538b2c, 8dde15e5-8f0f-43bd-847f-08f5c015e4a1, 69df5f84-1db1-4eb2-ae32-462137a4d812, 0a7f1a1b-961e-4458-8312-7920a78e4dbe, 3feb6452-372c-4c60-8e91-220be75f90b1, c6569dc4-2be9-48f4-8e03-6da27ac996b0, 67afee59-3d84-418f-832c-d00abd43fe5b, bb736981-167f-4de6-a285-0e840ae37fc7, 68180c67-ab30-49d0-aece-5a8d476097e2, 2535bcc8-fac7-4b15-8c6f-fd6675655fd3, 5cfd7234-5efc-4cb8-b69c-7e68b9f1a94f, 26ca9b31-f93f-4a92-8d13-651ade1e1c77, b8c52970-05b0-43ea-9122-566998bf4524, 941c8d76-48bb-4f96-82d4-b39ffaa9df49, e698a828-b2a3-4c5e-8597-27ed8127d1e4, 9c981813-533d-40b5-b9ea-5648dd7c7da0, e4d3b13a-e354-421d-917a-613ad0a3ab35, 6a92525c-bf1f-4a48-90a7-62e9baaa553d, 2351e0f7-3f55-4580-b424-0c76c4d9670a, 4a2276a1-54f6-4de6-8710-c2c088a23e76, 961973db-b7ab-40fa-ad75-4163738def9b, 532f72d6-a509-0681-e063-6294a90ad4c1, 71f493d9-3aaa-4b13-8057-012e96e11dbc, c4f0c0d0-430f-4c9d-96f0-8c90f6af31e8
- SPL set ID
- cefbc5f4-ef5f-4732-ab96-a69a183f0b6b, 57016639-89fe-43ad-89c4-5e7a756dddec, 9dae6824-6913-42de-b98a-cdcb0d3b4a46, e0d88f34-865c-441b-80e2-e814c9a7d670, 546103e1-ea6e-466b-b0de-b1ff8c494512, 57b5d67b-b29b-4c18-a53d-51d5374f3be3, 4087eb3c-96e9-4d0a-b80b-663e1c86d256, f07d81bc-5090-fbc5-2945-557cf002849c, 48169bbc-4fb2-4bc4-9bdd-de71bf7722df, 67dcdd6e-48bc-418e-a887-805929d83ce0, d1588c37-9da9-4ccb-b78a-64234938a115, 11e0924b-fbee-4ec4-b1e4-22d7683b21ee, 21628112-0c47-11df-95b3-498d55d89593, 691d276c-9cc1-4d39-828f-0f44d7ef6328, 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b, 9a943af0-1c6d-43c2-830a-f303baa16124, cb966bcb-3af7-4dbe-b540-58d473b891e5, e4886adf-199d-4b19-a4ef-75f8f94cb54e, a9d7c5ef-daf9-4f97-8673-7f4a2007f408, e2a4df59-fead-4a01-9021-9eda02c48010, 35312f49-decf-428d-bf5f-4215b762ed3c, 32b48ea0-a215-43b8-83b4-a5435a686d68, a5ca2fce-bd2d-40db-b963-e3ec27c8bf23, e310afcd-1260-434e-a994-34549c789d99, f72774dd-c7eb-41f9-9837-02baf77cc523, 46f54677-3a22-4c38-9b92-923020164e15, 9ac09563-5967-498c-93ae-675a7f4efc48, 2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef, 7bc4ec7a-9b83-4842-9057-e1a804b2596d, 035bf713-1642-4215-83ec-0ed07c29f92c, 690baf58-1ec9-463e-99b7-d601362ea56b, 872927eb-0b61-44bb-9892-3c700b6f2181, b94629e3-ae2e-473e-b2f5-06e32ee19aa9, 4f20155f-05b9-40ec-af34-3b58aa8d60d4, 54bfabce-1f8a-40ee-8b55-efce8fe6fbf1, 6ee00e82-799d-445e-b658-a9712c49a28e, 3c909a53-ae66-4b28-a741-b60bb25a69cf, ca4ec248-285d-4066-8f89-5ed0c538c4c9, dbc52b16-b93d-4d83-942b-485c502db1fa
- Package NDC
- 31722-181-60, 31722-181-05, 31722-182-60, 31722-182-05, 31722-183-60, 31722-183-05, 31722-184-60, 31722-184-05, 65841-647-14, 65841-647-16, 65841-647-01, 65841-647-05, 65841-648-14, 65841-648-16, 65841-648-01, 65841-648-05, 65841-649-14, 65841-649-16, 65841-649-01, 65841-649-05, 65841-650-14, 65841-650-16, 65841-650-01, 65841-650-05, 82009-135-05, 82009-136-05, 82009-137-05, 24979-210-04, 24979-211-04, 72865-313-60, 72865-313-10, 72865-314-60, 72865-314-10, 72865-315-60, 72865-315-10, 72865-316-60, 72865-316-10, 70771-1656-9, 70771-1656-3, 70771-1657-3 +349 more
- Nui
- N0000008486, N0000185506, N0000182140
- Pharm class pe
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Pharm class moa
- Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]
- UNII
- 0H73WJJ391
- Drugcharacterization
- 1
- Medicinalproduct
- DAIVOBET
- Drugauthorizationnumb
- 022185
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugadministrationroute
- 061
- Drugindication
- PSORIASIS
- Actiondrug
- 1
- Activesubstance
- Activesubstancename
- BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE
- Drugcharacterization
- 2
- Medicinalproduct
- EFFEXOR XR
- Drugseparatedosagenumb
- 2
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugadministrationroute
- 048
- Drugindication
- PRODUCT USED FOR UNKNOWN INDICATION
- Activesubstance
- Activesubstancename
- VENLAFAXINE HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- NDA020699
- Brand name
- EFFEXOR XR
- Generic name
- VENLAFAXINE HYDROCHLORIDE
- Manufacturer name
- Viatris Specialty LLC
- Product NDC
- 58151-125, 58151-126, 58151-127
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- VENLAFAXINE HYDROCHLORIDE
- RxCUI
- 313581, 313583, 313585, 729929, 729931, 729932
- SPL ID
- 2319042f-5d24-42d3-9b0a-8893bed66813
- SPL set ID
- c848a5d8-ba94-4c84-80e3-0bf35fb8e32e
- Package NDC
- 58151-125-93, 58151-125-77, 58151-126-93, 58151-126-77, 58151-127-93, 58151-127-77
- UNII
- 7D7RX5A8MO
- Drugcharacterization
- 1
- Medicinalproduct
- LIDOCAINE CONTAINING DERMAL FILLER (HYALURONIC ACID)
- Drugdosagetext
- 2 TO 3 INJECTIONS TOTAL
- Drugadministrationroute
- 061
- Drugindication
- PRODUCT USED FOR UNKNOWN INDICATION
- Activesubstance
- Activesubstancename
- HYALURONIC ACID\LIDOCAINE HYDROCHLORIDE
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20130823