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The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular thrombotic events [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Gastrointestinal effects [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Hepatic effects [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Congestive heart failure and edema [see WARNINGS AND PRECAUTIONS]
  • Renal effects [see WARNINGS AND PRECAUTIONS]
  • Anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Serious skin reactions [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions reported in clinical studies are nausea, flatulence, vomiting, and headache.

The most common reason for discontinuation due to adverse events in controlled trials of Caldolor is pruritus ( < 1%).

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical development, 560 patients were exposed to Caldolor, 438 in pain and 122 with fever. In the pain studies, Caldolor was started intra-operatively and administered at a dose of 400 mg or 800 mg every six hours for up to three days. In the fever studies, Caldolor was administered at doses of 100 mg, 200 mg, or 400 mg every four or six hours for up to 3 days.

The most frequent type of adverse reaction occurring with oral ibuprofen is gastrointestinal.

Pain Studies

The incidence rates of adverse reactions listed in the following table were derived from multi-center, controlled clinical studies in post-operative patients comparing Caldolor to placebo in patients also receiving morphine as needed for postoperative pain.

Table 1: Post-operative Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Caldolor Treatment Group in Pain Studies*

Event Caldolor Placebo
(N=287)
400 mg
(N=134)
800 mg
(N=304)
Any Reaction 118 (88%) 260 (86%) 258 (90%)
Nausea 77 (57%) 161 (53%) 179 (62%)
Vomiting 30 (22%) 46 (15%) 50 (17%)
Flatulence 10 (7%) 49 (16%) 44 (15%)
Headache 12 (9%) 35 (12%) 31 (11%)
Hemorrhage 13 (10%) 13 (4%) 16 (6%)
Dizziness 8 (6%) 13 (4%) 5 (2%)
Edema peripheral 1 (<1%) 9 (3%) 4 (1%)
Urinary retention 7 (5%) 10 (3%) 10 (3%)
Anemia 5 (4%) 7 (2%) 6 (2%)
Decreased hemoglobin 4 (3%) 6 (2%) 3 (1%)
Dyspepsia 6 (4%) 4 (1%) 2 (<1%)
Wound hemorrhage 4 (3%) 4 (1%) 4 (1%)
Abdominal discomfort 4 (3%) 2 (<1%) 0
Cough 4 (3%) 2 (<1%) 1 ( < 1%)
Hypokalemia 5 (4%) 3 (<1%) 8 (3%)
* All patients received concomitant morphine during these studies.

Fever Studies

Fever studies were conducted in febrile hospitalized patients with malaria and febrile hospitalized patients with varying causes of fever. In hospitalized febrile patients with malaria, the adverse reactions observed in at least two Caldolortreated patients included abdominal pain and nasal congestion.

In hospitalized febrile patients (all causes), adverse reactions observed in more than two patients in any given treatment group are presented in the table below.

Table 2: Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Caldolor Treatment Group in All- Cause Fever Study

Event Caldolor Placebo
N=28
100 mg
N=30
200 mg
N=30
400 mg
N=31
Any Reaction 27 (87%) 25 (83%) 23 (74%) 25 (89%)
Anemia 5 (17%) 6 (20%) 11 (36%) 4 (14%)
Eosinophilia 7 (23%) 7 (23%) 8 (26%) 7 (25%)
Hypokalemia 4 (13%) 4 (13%) 6 (19%) 5 (18%)
Hypoproteinemia 3 (10%) 0 4 (13%) 2 (7%)
Neutropenia 2 (7%) 2 (7%) 4 (13%) 2 (7%)
Blood urea increased 0 0 3 (10%) 0
Hypernatremia 2 (7%) 0 3 (10%) 0
Hypertension 0 0 3 (10%) 0
Hypoalbuminemia 3 (10%) 1 (3%) 3 (10%) 1 (4%)
Hypotension 0 2 (7%) 3 (10%) 1 (4%)
Diarrhea 3 (10%) 3 (10%) 2 (7%) 2 (7%)
Pneumonia bacterial 3 (10%) 1 (3%) 2 (7%) 0
Blood LDH increased 3 (10%) 2 (7%) 1 (3%) 1 (4%)
Thrombocythemia 3 (10%) 2 (7%) 1 (3%) 0
Bacteremia 4 (13%) 0 0 0