Drug Adverse Report

Substance Adverse Reports: EPIRUBICIN

Adverse Reports Registered By The FDA Adverse Event Reporting System (FAERS)

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities terminology.

Year: 2019. The FDA Adverse Event Reporting System (FAERS) registered 180 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
03
  • EPIRUBICIN
  • EPIRUBICIN ^ACTAVIS^
  • EPIRUBICIN ACTAVIS
  • EPIRUBICINA AHCL
  • EPIRUBICINE
  • EPIRUBICINE AHCL
  • EPIRUBICINE MYLAN
  • PHARMORUBICIN
02
  • EPIRUBICIN
  • EPIRUBICINA TEVA 2 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE
  • EPIRUBICINE
  • PHARMORUBICIN
  • PHARMORUBICIN RD
01
  • EPIRUBICIN
  • EPIRUBICINE
  • PHARMORUBICIN

Year: 2018. The FDA Adverse Event Reporting System (FAERS) registered 45 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
12
  • EPIRUBICIN
  • FLUOROURACIL
  • ADRUCIL
  • CARAC
  • EFUDEX
  • FLUOROPLEX
  • FLUOROURACIL
  • TOLAK
  • 0187-3202
  • 0187-3203
  • 0187-3204
  • 0187-5200
  • 0378-4791
  • 0703-3015
  • 0703-3018
  • 0703-3019
  • 16110-812
  • 16729-276
  • 25021-215
  • 43547-258
  • 43547-259
  • 51672-4062
  • 51672-4063
  • 51672-4118
  • 63323-117
  • 64370-421
  • 66530-249
  • 66530-258
  • 66758-044
  • 66758-054
  • 68001-266
  • 68083-269
  • 68083-270
  • 68083-292
  • 68083-293
11
  • EPIRUBICIN
  • ETHIODIZED OIL
  • LIPIODOL
  • 67684-1901
10
  • EPIRUBICIN
  • CISPLATIN
  • CISPLATIN
  • PLATINOL
  • PLATINOL-AQ
  • 0143-9504
  • 0143-9505
  • 0703-5747
  • 0703-5748
  • 16729-288
  • 44567-509
  • 44567-510
  • 44567-511
  • 44567-530
  • 47781-609
  • 47781-610
  • 61126-003
  • 61126-004
  • 63323-103
  • 68001-283
  • 68083-162
  • 68083-163
  • 70860-206
09
  • EPIRUBICIN
  • CAPECITABINE
  • GEMCITABINE HYDROCHLORIDE
  • LAPATINIB
  • TAMOXIFEN CITRATE
  • VINORELBINE TARTRATE
  • CAPECITABINE
  • CAPECITABINE 150MG
  • CAPECITABINE 500MG
  • GEMCITABINE
  • GEMCITABINE HYDROCHLORIDE
  • GEMZAR
  • NAVELBINE
  • SOLTAMOX
  • TAMOXIFEN CITRATE
  • TYKERB
  • VINORELBINE TARTRATE
  • XELODA
  • 0002-7501
  • 0002-7502
  • 0004-1100
  • 0004-1101
  • 0008-0045
  • 0054-0271
  • 0054-0272
  • 0078-0671
  • 0093-7473
  • 0093-7474
  • 0378-0144
  • 0378-0274
  • 0378-2511
  • 0378-2512
  • 0591-2472
  • 0591-2473
  • 16714-467
  • 16714-468
  • 16714-909
  • 16714-930
  • 16729-072
  • 16729-073
  • 16729-092
  • 16729-117
  • 16729-118
  • 23155-213
  • 23155-214
  • 23155-483
  • 23155-484
  • 23155-528
  • 23155-529
  • 25021-234
  • 25021-235
  • 45963-612
  • 45963-619
  • 45963-620
  • 51862-446
  • 51862-447
  • 51862-449
  • 51862-450
  • 59651-204
  • 59651-205
  • 60505-6113
  • 60505-6114
  • 60505-6115
  • 63759-3000
  • 63759-3001
  • 64370-532
  • 64980-276
  • 64980-277
  • 65162-843
  • 65162-844
  • 67457-462
  • 67457-463
  • 67457-464
  • 67457-616
  • 67457-617
  • 67457-618
  • 67877-458
  • 67877-459
  • 68001-282
  • 68083-148
  • 68083-149
  • 68382-826
  • 68382-827
  • 69097-313
  • 69097-314
  • 69097-948
  • 69097-949
  • 69539-019
  • 69539-020
  • 70771-1184
  • 70771-1185
  • 70860-204
  • 70860-205
  • 71288-113
  • 71288-114
  • 72205-006
  • 72205-007
  • 72485-204
  • 72485-205
  • 89141-123
08
  • EPIRUBICIN
07
  • EPIRUBICIN
06
  • EPIRUBICIN
05
  • EPIRUBICINA TEVA
02
  • EPIRUBICIN
01
  • EPIRUBICIN

Year: 2017. The FDA Adverse Event Reporting System (FAERS) registered 5 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
12
  • EPIRUBICIN
11
  • EPIRUBICIN
06
  • EPIRUBICIN
  • TRASTUZUMAB
  • HERCEPTIN
  • HERZUMA
  • 50242-132
  • 50242-134
  • 50242-333
  • 63459-303
  • 63459-305
04
  • EPIRUBICIN

Year: 2016. The FDA Adverse Event Reporting System (FAERS) registered 2 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
12
  • EPIRUBICIN

Year: 2015. The FDA Adverse Event Reporting System (FAERS) registered 2 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
12
  • EPIRUBICIN
  • FLUOROURACIL
  • ADRUCIL
  • CARAC
  • EFUDEX
  • FLUOROPLEX
  • FLUOROURACIL
  • TOLAK
  • 0187-3202
  • 0187-3203
  • 0187-3204
  • 0187-5200
  • 0378-4791
  • 0703-3015
  • 0703-3018
  • 0703-3019
  • 16110-812
  • 16729-276
  • 25021-215
  • 43547-258
  • 43547-259
  • 51672-4062
  • 51672-4063
  • 51672-4118
  • 63323-117
  • 64370-421
  • 66530-249
  • 66530-258
  • 66758-044
  • 66758-054
  • 68001-266
  • 68083-269
  • 68083-270
  • 68083-292
  • 68083-293
09
  • EPIRUBICIN

Year: 2014. The FDA Adverse Event Reporting System (FAERS) registered 1 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
05
  • EPIRUBICIN
  • CYCLOPHOSPHAMIDE
  • TRASTUZUMAB
  • CYCLOPHOSPHAMIDE
  • HERCEPTIN
  • HERZUMA
  • 0054-0382
  • 0054-0383
  • 0781-3233
  • 0781-3244
  • 0781-3255
  • 10019-935
  • 10019-936
  • 10019-937
  • 10019-938
  • 10019-939
  • 10019-942
  • 10019-943
  • 10019-944
  • 10019-945
  • 10019-955
  • 10019-956
  • 10019-957
  • 16714-857
  • 16714-858
  • 16714-859
  • 43975-307
  • 43975-308
  • 50242-132
  • 50242-134
  • 50242-333
  • 54879-021
  • 54879-022
  • 63459-303
  • 63459-305
  • 68001-370
  • 68001-371
  • 68001-372
  • 69097-516
  • 69097-517
  • 70121-1238
  • 70121-1239
  • 70121-1240
  • 72603-104
  • 72603-326
  • 72603-411

Year: 2013. The FDA Adverse Event Reporting System (FAERS) registered 1 drug adverse reports.

Month Report ID(s) Medicinal Product(s) Generic Name(s) Brand Name(s) Product NDC(s) Package NDC(s)
05
  • EPIRUBICIN
  • TRASTUZUMAB
  • HERCEPTIN
  • 50242-132
  • 50242-134
  • 50242-333

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