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Caldolor

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Caldolor

Caldolor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Caldolor (ibuprofen) injection is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever. Common side effects include nausea, gas, vomiting, and headache.

The dose of Caldolor for pain is 400 mg to 800 mg administered intravenously every 6 hours as necessary. The dose of Caldolor for fever is 400 mg intravenously, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. Caldolor may interact with aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, or methotrexate. Tell your doctor all medications and supplements you use. Caldolor should be used during the first 30 weeks of pregnancy only if prescribed. After 30 weeks, use of Caldolor is not recommended as it can harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Caldolor (ibuprofen) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Caldolor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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

Read the entire FDA prescribing information for Caldolor (Ibuprofen in Water for Injection) »

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