2007 Drug ADE Comparison


FDA/CVM Cumulative Adverse Drug Experiences Summaries.

As you may know, the format of the Cumulative Report was changed after 2005. According to the FDA/CVM it was for "openness and transparency" (easier to read/understand) . Due to this upgrade, there was not a December 2005 or January 2006 report.

Veterinarians and caregivers are encouraged to make reports. There is also a Glossary of terminology.

The chart below is a summary by chemical (alphabetically) name of the drugs that appear to be the most commonly requested. The numbers are 'possible, probable or definitely related' for a category of drug, route of administration and species.

Some of the differences noticed are: 'Died' use to be a total of deaths possibly related, now it is broken down into 'death' and 'euthanize'. It use to be 'reacted' and apparently is now 'evaluated'.

There are interesting charts in the May/June 2001 FDA Veterinarian on page 11. FDA/CVM 1999 Adverse Drug Event Reports - A Descriptive Overview. i.e. 1992 - 1,011 reports were made yet in 1999 - 9,731 were .

 

ED note December 2007 :

As of the December '07 FDA/CVM Cumulative report, they no longer give the amount of reactions for each sign.

Here you can find the top 20 reported reactions to each drug as of that date.

 

NSAIDs
Heartworm Preventatives

 

New/Misc Drugs Approved:
For:
topical moxidectin
fleas/heartworm
dirlotapide
weight mgmt
fluoxetine hydrochloride
separation anxiety
oral-maropitant citrate
vomiting
inj-maropitant citrate
vomiting
oral-pimobendan
heart failure

 

NSAIDs

carprofen - oral (Rimadyl®) (Novox®)

 NADA#141-053 ANADA #200-366 Manf:Pfizer® Manf: ImpaxLab® Approved: 10/15/96 Approved: 7.27/06
12/30/03 Report Treated: 12611 Reacted: 12209 Died: 2274
1/2/05 Report Treated: 12919 Reacted: 12516 Died: 2349
Nov '05 Report Treated: 14439 Reacted: 14032 Died: 3003
Dec '06 Report Evaluated: 14826
Death: 1692/ Euthanize: 1247 = 2939
Jan '07 Report Evaluated: 14826
Death: 1692/ Euthanize:1249 = 2941
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report Evaluated: 14832
Death: 1693/ Euthanize: 1249= 2942
May '07 Report Evaluated: 14841
Death: 1694/ Euthanize: 1250= 2944
June '07 Report Evaluated: 14846
Death: 1694/ Euthanize:1250 = 2944
July '07 Report Evaluated: 14854
Death: 1695/ Euthanize: 1251 = 2946
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 14911
(no other numbers given)
 
carprofen - inj (Rimadyl®)
 NADA#141-199 Manf:Pfizer® Approved: 5/3/03
12/30/03 Report Treated: 50 Reacted: 50 Died: 6
1/2/05 Report Treated: 144 Reacted: 165 Died: 36
Nov '05 Report Treated: 517 Reacted: 350 Died: 85
Dec '06 Report Evaluated: 505
Death: 72/ Euthanize: 40 = 112
Jan '07 Report Evaluated: 505
Death: 72/ Euthanize:40 = 112
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report Evaluated: 514
Death: 75/ Euthanize: 40= 115
May '07 Report
No Change
June '07 Report Evaluated: 595
Death: 82/ Euthanize:41 = 123
July '07 Report Evaluated: 598
Death: 82/ Euthanize: 41 = 123
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 652
(no other numbers given)
 
deracoxib - oral (Deramaxx®)
 NADA#141-203 Manf:Novartis® Approved: 8/21/02
12/30/03 Report Treated: 1133 Reacted: 1118 Died:  228
1/2/05 Report Treated: 2400 Reacted: 2371 Died:  515
Nov '05 Report Treated: 3593 Reacted: 3513 Died: 839
Dec '06 Report Evaluated: 3653
Death: 347/ Euthanize: 346 = 693
Jan '07 Report Evaluated: 3658
Death: 347/ Euthanize: 346= 693
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report
No Change
May '07 Report
No Change
June '07 Report
No Change
July '07 Report
No Change
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 3676
(no other numbers given)
 
etodolac - oral (Etogesic®)
 NADA#141-108 Manf:Wyeth® Approved: 7/22/98
12/30/03 Report Treated: 1655 Reacted: 1508 Died:  228
1/2/05 Report Treated: 1720 Reacted: 1573 Died:  158
Nov '05 Report Treated: 1950 Reacted: 1803 Died: 199
Dec '06 Report Evaluated: 1816
Death: 79/Euthanize: 70 = 149
Jan '07 Report Evaluated: 1816
Death: 79/ Euthanize: 70= 149
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report
No Change
May '07 Report
No Change
June '07 Report
No Change
July '07 Report
No Change
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 1816
(no other numbers given)
 
firocoxib - oral (Previcox®)
 NADA#141-230 Manf:Merial® Approved: 7/21/04
(not released till 2005)
Nov '05 Report Treated: 144 Reacted: 142 Died :18
Dec '06 Report Evaluated: 794
Death: 57/ Euthanize: 43 = 100
Jan '07 Report Evaluated: 874
Death: 62/ Euthanize: 46= 108
Feb '07 Report Evaluated: 970
Death: 65/ Euthanize:60 = 125
March '07 Report
(no report)
April '07 Report Evaluated: 1094
Death: 78/ Euthanize: 65= 143
May '07 Report Evaluated: 1202
Death: 82/ Euthanize: 69= 151
June '07 Report Evaluated: 1324
Death: 88/ Euthanize: 73= 161
July '07 Report Evaluated: 1344
Death: 88/ Euthanize: 73 = 161
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 1763
(no other numbers given)
 
meloxicam - oral (Metacam®)
 NADA#141-213 Manf:Boehringer Ingelheim Vetmedica® Approved: 4/15/03
12/30/03 Report Treated: 116 Reacted: 116 Died:  14
1/2/05 Report Treated: 436 Reacted: 436 Died:  46
Nov '05 Report Treated: 794 Reacted: 787 Died: 109
Dec '06 Report Evaluated: 1090
Death: 87/ Euthanize: 53 = 140
Jan '07 Report Evaluated: 1112
Death: 89/ Euthanize: 57= 146
Feb '07 Report Evaluated: 1124
Death:90 / Euthanize: 59= 149
March '07 Report
(no report)
April '07 Report Evaluated: 1141
Death: 93/ Euthanize: 60= 153
May '07 Report Evaluated: 1148
Death: 93/ Euthanize: 60= 153
June '07 Report Evaluated: 1186
Death: 103/ Euthanize: 61= 164
July '07 Report Evaluated: 1190
Death: 103/ Euthanize: 63 = 166
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 1260
(no other numbers given)
 
meloxicam - inj (Metacam®)
 NADA#141-219 Manf:Boehringer Ingelheim Vetmedica® Approved: 11/12/03
1/2/05 Report Treated: 22 Reacted: 22 Died:  4
Nov '05 Report Treated: 55 Reacted: 55 Died: 18
Dec '06 Report Evaluated: 89
Death: 21/ Euthanize: 3 = 24
Jan '07 Report Evaluated: 92
Death: 21/ Euthanize:3 = 24
Feb '07 Report Evaluated: 95
Death: 23/ Euthanize: 4= 27
March '07 Report
(no report)
April '07 Report Evaluated: 102
Death: 24/ Euthanize: 4= 28
May '07 Report
No Change
June '07 Report Evaluated: 111
Death: 28/ Euthanize: 5 = 33
July '07 Report
No Change
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 141
(no other numbers given)
 
tepoxalin - oral (Zubrin®)
 NADA#141-193 Manf:Schering-Plough® Approved: 3/31/03
12/30/03 Report Treated: 195 Reacted: 172 Died:  25
1/2/05 Report Treated: 450 Reacted: 422 Died:  57
Nov '05 Report Treated: 533 Reacted: 503 Died: 73
Dec '06 Report Evaluated: 608
Death: 34/ Euthanize: 37 = 71
Jan '07 Report Evaluated: 615
Death: 35/ Euthanize: 37= 72
Feb '07 Report Evaluated: 621
Death: 36/ Euthanize: 38= 74
March '07 Report
(no report)
April '07 Report Evaluated: 623
Death: 36/ Euthanize: 38= 74
May '07 Report Evaluated: 632
Death: 38/ Euthanize: 38= 76
June '07 Report Evaluated: 645
Death: 41/ Euthanize: 40= 81
July '07 Report Evaluated: 648
Death: 42/ Euthanize: 40 = 82
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 666
(no other numbers given)
 
Heartworm Preventatives

ivermectin - oral
(Heartgard®)
(IverHart®)
(Valuheart®)

NADA#138-412/140-886
NADA#200-270
NADA#oustide USA		 Manf: Merck®
Manf: Blue Ridge®
Manf: 		Approved: 7/89 10/96
Approved: 11/01
Approved: n/a
12/30/03 Report Treated: 1002 Reacted: 908 Died:  143
1/2/05 Report Treated: 1077 Reacted: 974 Died:  149
Nov '05 Report Treated:  1095 Reacted:  992 Died:  149
Dec '06 Report Evaluated: 1046
Death: 103/Euthanize: 6 = 109
Jan '07 Report Evaluated: 1060
Death: 103/ Euthanize: 6= 109
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report Evaluated: 1069
Death: 103/ Euthanize: 6 = 109
May '07 Report
No Change
June '07 Report
No Change
July '07 Report
No Change
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 1124
(no other numbers given)
 

ivermectin plus - oral
(Heartgard+®)
(IverHart+®)
(Triheart+®)

 NADA#140-971
NADA#200-302
NADA#200-338		 Manf: Merek®
Manf: BlueRidge®
Manf: Heske®		 Approved: 1/15/93
Approved: 5/30/01
Approved: 8/03
12/30/03 Report Treated: 2841 Reacted: 2752 Died:  51
1/2/05 Report Treated: 4966 Reacted: 4676 Died:  79
Nov '05 Report Treated:  5066 Reacted:  4771 Died:  83
Dec '06 Report Evaluated: 7969
Death: 65/ Euthanize: 18 = 83
Jan '07 Report Evaluated: 8142
Death: 66/ Euthanize: 18= 84
Feb '07 Report Evaluated: 8438
Death: 66/ Euthanize: 20= 86
March '07 Report
(no report)
April '07 Report Evaluated: 9472
Death: 69/ Euthanize: 20= 89
May '07 Report Evaluated: 9613
Death: 70/ Euthanize: 20= 90
June '07 Report Evaluated: 9871
Death: 70/ Euthanize:20 = 90
July '07 Report Evaluated: 9872
Death: 70/ Euthanize: 20 = 90
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 9923
(no other numbers given)
 
milbemycin - oral (Interceptor®)
 NADA#140-915 Manf: Novartis® Approved: 12/29/92
12/30/03 Report Treated: 1174 Reacted: 1097 Died:  83
1/2/05 Report Treated: 2384 Reacted: 2299 Died:  127
Nov '05 Report Treated:  2386 Reacted:  2301 Died:  128
Dec '06 Report Evaluated: 4233
Death: 111/ Euthanize: 29 = 140
Jan '07 Report Evaluated: 4393
Death: 118/ Euthanize: 32= 150
Feb '07 Report Evaluated: 4473
Death: 121/ Euthanize: 32= 153
March '07 Report
(no report)
April '07 Report Evaluated: 4745
Death: 125/ Euthanize: 33= 158
May '07 Report
No Change
June '07 Report
No Change
July '07 Report Evaluated: 4759
Death: 125/ Euthanize: 33 = 158
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 4760
(no other numbers given)
 
milbemycin/luf - oral (Sentinel®)
 NADA#141-084 Manf: Novartis® Approved: 3/18/98
12/30/03 Report Treated: 662 Reacted: 595 Died:  24
1/2/05 Report Treated: 1039 Reacted: 971 Died:  40
Nov '05 Report Treated:  1039 Reacted:  971 Died:  40
Dec '06 Report Evaluated: 1515
Death: 26/ Euthanize: 10 = 36
Jan '07 Report Evaluated: 1532
Death: 26/ Euthanize: 11= 37
Feb '07 Report Evaluated: 1578
Death: 27/ Euthanize: 11= 38
March '07 Report
(no report)
April '07 Report Evaluated: 1679
Death: 29/ Euthanize: 13= 42
May '07 Report Evaluated: 1745
Death: 29/ Euthanize: 13= 42
June '07 Report Evaluated: 1777
Death: 30/ Euthanize: 13= 43
July '07 Report Evaluated: 1791
Death: 30/ Euthanize: 13 = 43
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 1851
(no other numbers given)
 
moxidectin - oral (Proheart® tablets)
 NADA#141-051 Manf: Fort Dodge® Approved: 5/17/97
12/30/03 Report Treated: 367 Reacted: 333 Died:  60
1/2/05 Report Treated: 390 Reacted: 352 Died:  62
Nov '05 Report Treated:  394 Reacted:  356 Died:  62
Dec '06 Report Evaluated: 364
Death: 58/ Euthanize: 5 = 63
Jan '07 Report Evaluated: 365
Death: 58/ Euthanize: 5= 63
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report Evaluated: 365
Death: 58/ Euthanize: 5 = 63
May '07 Report
No Change
June '07 Report
No Change
July '07 Report
No Change
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 366
(no other numbers given)
 
moxidectin - inj (Proheart® 6)
 NADA#141-189 Manf: Fort Dodge® Approved: 6/21/01
12/30/03 Report Treated: 4268 Reacted: 4085 Died:  365
1/2/05 Report Treated: 6042 Reacted: 5473 Died:  599
Nov '05 Report Treated:  6042 Reacted:  5473 Died:  599
Dec '06 Report Evaluated: 5473
Death: 344/Euthanize: 137 = 481
Jan '07 Report
No Change
Feb '07 Report
No Change
March '07 Report
(no report)
April '07 Report
No Change
May '07 Report
No Change
June '07 Report
No Change
July '07 Report
No Change
Augut '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 5989
(no other numbers given)
 
moxidectin - topical (AdvantageMulti®)
 NADA#141-251 Manf: Bayer® Approved: 12/20/06
July '07 Report Evaluated: 6
Death: 0/ Euthanize: 0= 0
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 6
(no other numbers given)
 
selamectin - topical (Revolution®)
 NADA#141-152 Manf: Pfizer® Approved: 5/26/99
12/30/03 Report Treated: 8622 Reacted: 8434 Died:  180
1/2/05 Report Treated: 9736 Reacted: 9544 Died:  223
Nov '05 Report Treated:  9744 Reacted:  9552 Died:  224
Dec '06 Report Evaluated: 10510
Death: 142/ Euthanize: 48 = 190
Jan '07 Report Evaluated: 10519
Death: 142/ Euthanize:48 = 190
Feb '07 Report Evaluated: 10601
Death: 144/ Euthanize: 49= 193
March '07 Report
(no report)
April '07 Report Evaluated: 10674
Death:145 / Euthanize: 49= 194
May '07 Report Evaluated: 10758
Death: 147/ Euthanize:50 = 197
June '07 Report Evaluated: 10917
Death: 152/ Euthanize: 50= 202
July '07 Report Evaluated: 11018
Death: 153/ Euthanize: 51 = 204
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 11416
(no other numbers given)
 

 

dirlotapide-oral (Slentrol®)
 NADA#141-260 Manf: Pfizer® Approved: 12/12/06
July '07 Report Evaluated: 9
Death: 0/ Euthanize: 0 = 0
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 94
(no other numbers given)
 
fluoxetine hydrochloride - oral (Reconcile®)
NADA#141-272 Manf: Elano/Eli Lilley® Approved: 1/19/07
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 151
(no other numbers given)
 
maropitant citrate - oral (Cerenia®)
NADA#141-262 Manf: Pfizer® Approved: 1/29/07
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 14
(no other numbers given)
 
maropitant citrate - inj (Cerenia®)
NADA#141-263 Manf: Pfizer® Approved: 1/29/07
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 66
(no other numbers given)
 
pimobendan - oral (Vetmedin®)
 NADA#141-273 Manf: Boehringer ® Approved: 5/16/07
May '07 Report Evaluated: 6
Death: 1/Euthanize: 0 = 1
June '07 Report
No Change
July '07 Report
No Change
August '07 Report
(no report)
September '07 Report
(no report)
October '07 Report
(no report)
November '07 Report
(no report)
December '07 Report Evaluated: 16
(no other numbers given)
 

 

2006 Details by month

2008 Details by month

2009 Details by month