Substance Adverse Reports: CETUXIMAB

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 271 drug adverse reports.
Month	Report ID(s)	Medicinal Product(s)	Generic Name(s)	Brand Name(s)	Product NDC(s)	Package NDC(s)
03	16023873 16024058 16024064 16025819 16025970 16025987 16026789 16032997 16033184 16036489 16036547 16037465 16038179 16044914 16045640 16045642 16047288 16047855 16049604 16049605 16049611 16051088 16054915 16057920 16058334 16059299 16061383 16062012 16063245 16068263 16068510 16068554 16069844 16070130 16070999 16072465 16072751 16073182 16074201 16076986 16078960 16078970 16083217 16085430 16086591 16086593 16086594 16088329 16092853 16095848 16097792 16100508 16101576 16102724 16104311 16105638 16105836 16105851 16106270 16106760 16107026 16108596 16109363 16109492 16110424 16112370 16112617 16114821 16114991 16116447 16118456 16121234 16121482 16124737 16127134 16129479 16129878 16130514 16131337 16135954 16135957 16135958 16135960 16135961 16135971 16135972 16138298 16138345 16138628	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
02	15898336 15898674 15899359 15899949 15899955 15899959 15901232 15902019 15903117 15905587 15911382 15916953 15917152 15918945 15920995 15929140 15930653 15932507 15933422 15933423 15933424 15933757 15933960 15934649 15934844 15935898 15936579 15937832 15937835 15940805 15940922 15942673 15946174 15947176 15947269 15947327 15951314 15952015 15953005 15953358 15953956 15954310 15954871 15954887 15955893 15956642 15956646 15960030 15962872 15968247 15969312 15969316 15975405 15977259 15977264 15979220 15981968 15982439 15982440 15982535 15982657 15982671 15983844 15983978 15984838 15986558 15989117 15989120 15989133 15990697 15990702 15991275 15991452 15993172 15995618 15995625 15996896 15997213 15998504 16002105 16002108 16002109 16002111 16002114 16004055 16004766 16004854 16004859 16007298 16011029 16012386 16016691 16016807 16018485 16018593 16019552 16030285	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
01	15782780 15783856 15786163 15786166 15791184 15791481 15791482 15792585 15792743 15795786 15796492 15799814 15800929 15801564 15804275 15804564 15805874 15806034 15806475 15806611 15809276 15810852 15811112 15813835 15814838 15814850 15819374 15819802 15821574 15823414 15823864 15823865 15823866 15826632 15826883 15827293 15827471 15827644 15839242 15842711 15843772 15848473 15849410 15849643 15852526 15854315 15855042 15855175 15857209 15857962 15859557 15859560 15859563 15861137 15861594 15864522 15864524 15864525 15864529 15864536 15866970 15866992 15867468 15867576 15869266 15878064 15880896 15881472 15882408 15882558 15883443 15884619 15885585 15885590 15885671 15887259 15887807 15887858 15889551 15889799 15890621 15890849 15893569 15893571 15893620	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23

Year: 2018. The FDA Adverse Event Reporting System (FAERS) registered 47 drug adverse reports.
Month	Report ID(s)	Medicinal Product(s)	Generic Name(s)	Brand Name(s)	Product NDC(s)	Package NDC(s)
12	15696255 15705316 15706757 15718960 15734616 15745370 15749562 15750390 15752566 15752567 15762655 15769776 15770547 15770552 15770556	BLINDED CETUXIMAB CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
11	15603522 15605765 15623233 15623728 15635713 15643663 15667499	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
10	15527900 15528525	ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
09	15375806 15422604	CETUXIMAB.	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
08	15310746 15316185 15328447	BLINDED CETUXIMAB CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
07	15105548 15170199	ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
06	14971278 14997224 15059087 15066897	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
05	14843446 14871719 14895858 14897616 14916381 14952839	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
04	14732986	CETUXIMAB.
03	14584922 14615757 14620328 14659982	CETUXIMAB. ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
02	14533473	CETUXIMAB.

Year: 2017. The FDA Adverse Event Reporting System (FAERS) registered 8 drug adverse reports.
Month	Report ID(s)	Medicinal Product(s)	Generic Name(s)	Brand Name(s)	Product NDC(s)	Package NDC(s)
12	14327504	ERBITUX
10	14046713	ERBITUX
09	13930548 13967608	ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23
08	13891960 13916432	CETUXIMAB.	AFLIBERCEPT CETUXIMAB	ERBITUX EYLEA	61755-005 66733-948 66733-958	61755-005-02 61755-005-55 66733-948-23 66733-958-23
05	13581532	CETUXIMAB.
02	13203298	ERBITUX

Year: 2016. The FDA Adverse Event Reporting System (FAERS) registered 3 drug adverse reports.
Month	Report ID(s)	Medicinal Product(s)	Generic Name(s)	Brand Name(s)	Product NDC(s)	Package NDC(s)
07	12583766	ERBITUX
05	12366844 12396256	CETUXIMAB.	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23

Year: 2015. 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)
11	11776343	CETUXIMAB.	CAPECITABINE	CAPECITABINE CAPECITABINE 150MG CAPECITABINE 500MG XELODA	0004-1100 0004-1101 0054-0271 0054-0272 0093-7473 0093-7474 0378-2511 0378-2512 16714-467 16714-468 16729-072 16729-073 59651-204 59651-205 63759-3000 63759-3001 64980-276 64980-277 65162-843 65162-844 67877-458 67877-459 69097-948 69097-949 69539-019 69539-020 72205-006 72205-007 72485-204 72485-205	0004-1100-20 0004-1101-50 0054-0271-21 0054-0272-23 0093-7473-06 0093-7474-89 0378-2511-91 0378-2512-78 16714-467-01 16714-468-01 16729-072-12 16729-073-29 59651-204-10 59651-204-60 59651-205-08 59651-205-10 63759-3000-1 63759-3001-1 64980-276-06 64980-277-12 65162-843-06 65162-844-06 65162-844-16 65162-844-50 67877-458-12 67877-458-30 67877-458-60 67877-459-12 67877-459-30 67877-459-60 69097-948-08 69097-949-03 69539-019-60 69539-019-99 69539-020-92 69539-020-99 72205-006-60 72205-007-92 72485-204-60 72485-205-12

Year: 2012. 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)
12	8973771	ERBITUX

Year: 2011. 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)
09	8122357	ERBITUX
01	7755472	ERBITUX

Year: 2010. 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)
12	7745229	ERBITUX

Year: 2007. 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)
06	6346296	ERBITUX	CETUXIMAB	ERBITUX	66733-948 66733-958	66733-948-23 66733-958-23

Substance Adverse Reports: CETUXIMAB

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

Year: 2019. The FDA Adverse Event Reporting System (FAERS) registered 271 drug adverse reports.

Year: 2018. The FDA Adverse Event Reporting System (FAERS) registered 47 drug adverse reports.

Year: 2017. The FDA Adverse Event Reporting System (FAERS) registered 8 drug adverse reports.

Year: 2016. The FDA Adverse Event Reporting System (FAERS) registered 3 drug adverse reports.

Year: 2015. The FDA Adverse Event Reporting System (FAERS) registered 1 drug adverse reports.

Year: 2012. The FDA Adverse Event Reporting System (FAERS) registered 1 drug adverse reports.

Year: 2011. The FDA Adverse Event Reporting System (FAERS) registered 2 drug adverse reports.

Year: 2010. The FDA Adverse Event Reporting System (FAERS) registered 1 drug adverse reports.

Year: 2007. The FDA Adverse Event Reporting System (FAERS) registered 1 drug adverse reports.