Caldolor
- Generic Name: ibuprofen in water for injection
- Brand Name: Caldolor
Caldolor (Ibuprofen in Water for Injection) side effects drug center
Caldolor Side Effects Center
What Is Caldolor?
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.
What Are Side Effects of Caldolor?
Common side effects of Caldolor include:
- nausea
- gas
- vomiting
- dizziness, and
- headache
Dosage for Caldolor
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.
What Drugs, Substances, or Supplements Interact with Caldolor?
Caldolor may interact with aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, or methotrexate. Tell your doctor all medications and supplements you use.
Caldolor During Pregnancy or Breastfeeding
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.
Additional Information
Our Caldolor (ibuprofen) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Caldolor Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Tell your caregivers at once if you have:
- changes in your vision;
- swelling, rapid weight gain, feeling short of breath;
- severe headache, pounding in your neck or ears;
- little or no urination;
- high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
- liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
If your baby has been treated with Neoprofen, tell the doctor at once if the baby has:
- signs of infection such as fever, chills, fussiness;
- unusual bleeding; or
- bruising, swelling, warmth, redness, or irritation where the IV needle is placed.
Common side effects may include:
- nausea, vomiting, gas;
- headache; or
- dizziness.
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.
Read the entire detailed patient monograph for Caldolor (Ibuprofen in Water for Injection)
Caldolor Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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.
Adult Population
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 post-operative 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 CALDOLOR-treated 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 |
Pediatric Population
A total of 143 pediatric patients ages 6 months and older have received CALDOLOR in controlled clinical trials. 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.
DRUG INTERACTIONS
See Table 3 for clinically significant drug interactions with ibuprofen.
Table 3: Clinically Significant Drug Interactions with Ibuprofen
| Drugs That Interfere with Hemostasis | |
| Clinical Impact: |
|
| Intervention: | Monitor patients with concomitant use of CALDOLOR with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS]. |
| Aspirin | |
| Clinical Impact: | Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | Concomitant use of CALDOLOR and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. CALDOLOR is not a substitute for low dose aspirin for cardiovascular protection. |
| ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |
| Clinical Impact: |
|
| Intervention: |
|
| Diuretics | |
| Clinical Impact: | Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. |
| Intervention: | During concomitant use of CALDOLOR with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS]. |
| Digoxin | |
| Clinical Impact: | The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. |
| Intervention: | During concomitant use of CALDOLOR and digoxin, monitor serum digoxin levels. |
| Lithium | |
| Clinical Impact: | NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
| Intervention: | During concomitant use of CALDOLOR and lithium, monitor patients for signs of lithium toxicity. |
| Methotrexate | |
| Clinical Impact: | Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
| Intervention: | During concomitant use of CALDOLOR and methotrexate, monitor patients for methotrexate toxicity. |
| Cyclosporine | |
| Clinical Impact: | Concomitant use of CALDOLOR and cyclosporine may increase cyclosporine's nephrotoxicity. |
| Intervention: | During concomitant use of CALDOLOR and cyclosporine, monitor patients for signs of worsening renal function. |
| NSAIDs and Salicylates | |
| Clinical Impact: | Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended. |
| Pemetrexed | |
| Clinical Impact: | Concomitant use of CALDOLOR and pemetrexed, may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
| Intervention: |
|
Read the entire FDA prescribing information for Caldolor (Ibuprofen in Water for Injection)
© Caldolor Patient Information is supplied by Cerner Multum, Inc. and Caldolor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.