In pivotal trials, the most common adverse reactions in adult patients are nausea, vomiting, headache, hemorrhage and dizziness (>5%). The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (>2%).
An integrated analysis of data from ten sponsored clinical studies was performed to assess the safety of CALDOLOR in adults. Overall, 1,752 adult patients have been included in safety and efficacy trials over 11 years; 1,220 of these patients have received CALDOLOR and 532 received either placebo or comparator medication.
N = 1149
N = 452
|Any Adverse Event||691 (60)||384 (85)|
|Nausea||299 (26)||213 (47)|
|Vomiting||109 (9)||64 (14)|
|Constipation||85 (7)||62 (14)|
|Flatulence||77 (7)||44 (10)|
|Pruritus||72 (6)||65 (14)|
|Infusion Site Pain||62 (5)||1 (1)|
|Headache||59 (5)||37 (8)|
|Pyrexia||41 (4)||47 (10)|
|Anemia||50 (4)||23 (5)|
Notes: aExcludes studies NCT01650519 and NCT01901393 where non-serious AEs were not collected. bPercentages less than 1 were rounded to 1.
Abbreviations: N, number
A total of 143 pediatric patients ages 6 months and older have received CALDOLOR in controlled clinical trials. In the pediatric fever study, patients received an average of four doses of CALDOLOR (range 1-23 doses). In the pediatric pain study, patients received a single dose of CALDOLOR prior to a tonsillectomy surgery. The most common adverse reactions (incidence greater than or equal to 2%) in pediatric patients treated with CALDOLOR were infusion site pain, vomiting, nausea, anemia and headache.
The CALDOLOR vial stopper is NOT made with natural rubber latex.
CALDOLOR must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis. CALDOLOR should not be given as an IV bolus or IM injection.1