2008 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.
In place of the numbers, the ranking  of 'death' and 'euthanize' out of total ADE's for that drug has been added.  For example, all heartworm preventatives have in-effectiveness in the top 5 places as most reported ADE.

Here you can find the top 20 reported reactions to each drug as of that 12/7/07.

 

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
July '07 Report Evaluated: 14854
Death: 1695/ Euthanize: 1251 = 2946
December '07 Report Evaluated: 14911
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 14958 Death: 7th Euthanize: 10th
March '08 *No Report*
     
April '08 Report Evaluated: 14958 Death: 7th Euthanize: 10th
May '08 *No Report*
     
June '08 Report Evaluated: 14977 Death: 6th Euthanize: 9th
July '08 Report Evaluated: 14986 Death: 7th Euthanize: 10th
August '08 *No Report*
     
       
       
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
July '07 Report Evaluated: 598
Death: 82/ Euthanize: 41 = 123
December '07 Report Evaluated: 652
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 670 Death: 4th Euthanize: 13th
March '08 *No Report*
     
April '08 Report Evaluated: 677 Death: 4th Euthanize: 13th
May '08 *No Report*
     
June '08 Report Evaluated: 757 Death: 6th Euthanize: 14th
July '08 Report Evaluated: 757 Death: 6th Euthanize: 14th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 3658
Death: 347/ Euthanize: 346 = 693
December '07 Report Evaluated: 3676
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 3677 Death: 10th Euthanize: 11th
March '08 *No Report*
     
April '08 Report Evaluated: 3682 Death: 10th Euthanize: 11th
May '08 *No Report*
     
June '08 Report Evaluated: 3687 Death: 10th Euthanize: 11th
July '08 Report Evaluated: 3691 Death: 10th Euthanize: 11th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 1816
Death: 79/ Euthanize: 70 = 149
December '07 Report Evaluated: 1816
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 1816 Death: 13th Euthanize: 15th
March '08 *No Report*
     
April '08 Report Evaluated: 1816 Death: 13th Euthanize: 15th
May '08 *No Report*
     
June '08 Report Evaluated: 1816 Death: 13th Euthanize: 15th
July '08 Report Evaluated: 1816 Death: 13th Euthanize: 15th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 1344
Death: 88/ Euthanize: 73 = 161
December '07 Report Evaluated: 1763
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 1876 Death: 12th Euthanize: 14th
March '08 *No Report*
     
April '08 Report Evaluated: 1960 Death: 11th Euthanize: 14th
May '08 *No Report*
     
June '08 Report Evaluated: 2025 Death: 10th Euthanize: 13th
July '08 Report Evaluated: 1040 Death: 11th Euthanize: 14th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 1190
Death: 103/ Euthanize: 63 = 166
December '07 Report Evaluated: 1260
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 1277 Death: 7th Euthanize: 10th
March '08 *No Report*
     
April '08 Report Evaluated: 1317 Death: 7th Euthanize: 10th
May '08 *No Report*
     
June '08 Report Evaluated: 1341 Death: 7th Euthanize: 10th
July '08 Report Evaluated: 1341 Death: 7th Euthanize: 10th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 111
Death: 28/ Euthanize: 5 = 33
December '07 Report Evaluated: 141
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 141 Death: 2nd Euthanize: 19th
March '08 *No Report*
     
April '08 Report Evaluated: 195 Death: 3rd Euthanize: 18th
May '08 *No Report*
     
June '08 Report Evaluated: 197 Death: 3rd Euthanize: 18th
July '08 Report Evaluated: 197 Death: 3rd Euthanize: 18th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 648
Death: 42/ Euthanize: 40 = 82
December '07 Report Evaluated: 666
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 668 Death: 8th Euthanize: 10th
March '08 *No Report*
     
April '08 Report Evaluated: 669 Death: 8th Euthanize: 10th
May '08 *No Report*
     
June '08 Report Evaluated: 679 Death: 8th Euthanize: 10th
July '08 Report Evaluated: 701 Death: 8th Euthanize: 10th
August '08 *No Report*
     
       
       
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
July '07 Report Evaluated: 1069
Death: 103/ Euthanize: 6 = 109
December '07 Report Evaluated: 1124
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 1125 Death: 7th Euthanize: 66th
March '08 *No Report*
     
April '08 Report Evaluated: 1135 Death: 7th Euthanize: 66th
May '08 *No Report*
     
June '08 Report Evaluated: 1144 Death: 7th Euthanize: 68th
July '08 Report Evaluated: 1148 Death: 7th Euthanize: 68th
August '08 *No Report*
     
       

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
July '07 Report Evaluated: 9872
Death: 70/ Euthanize: 20 = 90
December '07 Report Evaluated: 9923
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 9923 Death: 14th Euthanize: 35th
March '08 *No Report*
     
April '08 Report Evaluated: 9923 Death: 14th Euthanize: 35th
May '08 *No Report*
     
June '08 Report Evaluated: 9923 Death: 14th Euthanize: 35th
July '08 Report Evaluated: 9924 Death: 14th Euthanize: 35th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 4759
Death: 125/ Euthanize: 33 = 158
December '07 Report Evaluated: 4760
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 4760 Death: 9th Euthanize: 30th
March '08 *No Report*
     
April '08 Report Evaluated: 4760 Death: 9th Euthanize: 30th
May '08 *No Report*
     
June '08 Report Evaluated: 4760 Death: 9th Euthanize: 30th
July '08 Report Evaluated: 4760 Death: 9th Euthanize: 30th
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 1791
Death: 30/ Euthanize: 13 = 43
December '07 Report Evaluated: 1851
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 1851 Death: 11th Euthanize: 32nd
March '08 *No Report*
     
April '08 Report Evaluated: 1851 Death: 11th Euthanize: 32nd
May '08 *No Report*
     
June '08 Report Evaluated: 1851 Death: 11th Euthanize: 32nd
July '08 Report Evaluated: 1852 Death: 11th Euthanize: 32nd
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 365
Death: 58/ Euthanize: 5 = 63
December '07 Report Evaluated: 366
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 367 Death: 4th Euthanize: 31st
March '08 *No Report*
     
April '08 Report Evaluated: 369 Death: 5th Euthanize: 31st
May '08 *No Report*
     
June '08 Report Evaluated: 369 Death: 5th Euthanize: 31st
July '08 Report Evaluated: 369 Death: 5th Euthanize: 31st
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 5473
Death: 344/ Euthanize: 137 = 481
December '07 Report Evaluated: 5989
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 6453 Death: 9th Euthanize: 20th
April '08 Report Evaluated: 6482 Death: 9th Euthanize: 18th
May '08 *No Report*
     
June '08 Report Evaluated: 6482 Death: 9th Euthanize: 19th
*re-released 6/5/08*
     
July '08 Report Evaluated: 6482 Death: 9th Euthanize: 19th
August '08 *No Report*
     
       
moxidectin - topical (AdvantageMulti®)
 NADA#141-251 Manf: Bayer® Approved: 12/20/06
July '07 Report Evaluated: 6
Death: 0/ Euthanize: 0= 0
December '07 Report Evaluated: 6
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 6 Death: 0 Euthanize: 0
March '08 *No Report*
     
April '08 Report Evaluated: 6 Death: 0 Euthanize: 0
May '08 *No Report*
     
June '08 Report Evaluated: 6 Death: 0 Euthanize: 0
July '08 Report Evaluated: 6 Death: 0 Euthanize: 0
August '08 *No Report*
     
       
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
July '07 Report Evaluated: 11018
Death: 153/ Euthanize: 51 = 204
December '07 Report Evaluated: 11416
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 11420 Death: 16th Euthanize: 42nd
March '08 *No Report*
     
April '08 Report Evaluated: 11423 Death: 16th Euthanize: 42nd
May '08 *No Report*
     
June '08 Report Evaluated: 11426 Death: 16th Euthanize: 42nd
July '08 Report Evaluated: 11426 Death: 16th Euthanize: 42nd
August '08 *No Report*
     
       

 

Other Drugs
dirlotapide-oral (Slentrol®)
 NADA#141-260 Manf: Pfizer® Approved: 12/12/06
July '07 Report Evaluated: 9
Death: 0/ Euthanize: 0 = 0
December '07 Report Evaluated: 94
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 203 Death: 11th Euthanize: 14th
March '08 *No Report*
     
April '08 Report Evaluated: 403 Death: 13th Euthanize: 14th
May '08 *No Report*
     
June '08 Report Evaluated: 461 Death: 11th Euthanize: 16th
July '08 Report Evaluated: 490 Death: 11th Euthanize: 17th
August '08 *No Report*
     
       
fluoxetine hydrochloride - oral (Reconcile®)
NADA#141-272 Manf: Elano/Eli Lilley® Approved: 1/19/07
December '07 Report Evaluated: 151
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 214 Death: 19th Euthanize: 45th
March '08 *No Report*
     
April '08 Report Evaluated: 229 Death: 19th Euthanize: 45th
May '08 *No Report*
     
June '08 Report Evaluated: 269 Death: 19th Euthanize: 49th
July '08 Report Evaluated: 280 Death: 20th Euthanize: 55th
August '08 *No Report*
     
       
maropitant citrate - oral (Cerenia®)
NADA#141-262 Manf: Pfizer® Approved: 1/29/07
December '07 Report Evaluated: 14
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 37 Death: 5th Euthanize: 4th
March '08 *No Report*
     
April '08 Report Evaluated: 71 Death: 9th Euthanize: 8th
May '08 *No Report*
     
June '08 Report Evaluated: 83 Death: 5th Euthanize: 8th
July '08 Report Evaluated: 92 Death: 4th Euthanize: 9th
August '08 *No Report*
     
       
maropitant citrate - inj (Cerenia®)
NADA#141-263 Manf: Pfizer® Approved: 1/29/07
December '07 Report Evaluated: 66
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 110 Death: 3rd Euthanize: 5th
March '08 *No Report*
     
April '08 Report Evaluated: 250 Death: 5th Euthanize: 6th
May '08 *No Report*
     
June '08 Report Evaluated: 857 Death: 6th Euthanize: 8th
July '08 Report Evaluated: 872 Death: 6th Euthanize: 8th
August '08 *No Report*
     
       
pimobendan - oral (Vetmedin®)
 NADA#141-273 Manf: Boehringer ® Approved: 5/16/07
July '07 Report
Evaluated: 6
Death: 1/Euthanize: 0 = 1
December '07 Report Evaluated: 16
(no other numbers given)
January '08 *No Report*
      
February '08 Report Evaluated: 83 Death: 2nd Euthanize: 10th
March '08 *No Report*
     
April '08 Report Evaluated: 90 Death: 1st Euthanize: 9th
May '08 *No Report*
     
June '08 Report Evaluated: 102 Death: 1st Euthanize: 8th
July '08 Report Evaluated: 169 Death: 3rd Euthanize: 13th
August '08 *No Report*
     
       

 

2006 Details by month

2007 Details by month

 

Last updated 9/13/08

As of this date there was not a September Report