Note: This document contains side effect information about ibuprofen. Some dosage forms listed on this page may not apply to the brand name Caldolor.

Summary

Common side effects of Caldolor include: hemorrhage, vomiting, anemia, eosinophilia, and hypertension. Other side effects include: upper gastrointestinal hemorrhage, upper gastrointestinal tract ulcer, dizziness, and dyspepsia. Continue reading for a comprehensive list of adverse effects.

Applies to ibuprofen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable. Other dosage forms:

• intravenous solution

Serious side effects of Caldolor

Along with its needed effects, ibuprofen (the active ingredient contained in Caldolor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ibuprofen:

More common

• Abdominal pain
• acid or sour stomach
• belching
• bloating
• cloudy urine
• decrease in amount of urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines
• full feeling
• heartburn
• indigestion
• itching skin
• pain or discomfort in chest, upper stomach, or throat
• pale skin
• passing gas
• nausea
• noisy, rattling breathing
• rash with flat lesions or small raised lesions on the skin
• shortness of breath
• swelling of face, fingers, hands, feet, lower legs, or ankles
• troubled breathing at rest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain

Less common

• Abdominal cramps
• stomach soreness or discomfort

Rare

• Agitation
• back, leg, or stomach pains
• bleeding gums
• blistering, peeling, loosening of skin
• blood in urine or stools
• bloody, black, or tarry stools
• blurred vision
• burning feeling in chest or stomach
• change in vision
• chest pain
• chills
• clay-colored stools
• coma
• confusion
• constipation
• cough or hoarseness
• dark urine
• decreased urine output
• depression
• difficulty breathing
• difficulty swallowing
• dilated neck veins
• dizziness
• dry mouth
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• fever with or without chills
• frequent urination
• general body swelling
• general feeling of tiredness or weakness
• hair loss, thinning of hair
• headache
• hives or welts
• hostility
• impaired vision
• increased blood pressure
• increased volume of pale, dilute urine
• irregular breathing
• irritability
• itching
• joint or muscle pain
• lab results that show problems with liver
• lethargy
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle twitching
• nosebleeds
• painful or difficult urination
• pains in stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of skin
• seizures
• severe abdominal pain, cramping, burning
• severe and continuing nausea
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stiff neck or back
• stomach upset
• stupor
• swollen or painful glands
• tenderness in stomach area
• thirst
• tightness in chest
• unpleasant breath odor
• upper right abdominal pain
• vomiting of blood
• vomiting of material that looks like coffee grounds
• wheezing
• yellow eyes and skin

Symptoms of overdose

• Bluish lips or skin
• difficulty sleeping
• disorientation
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness to profound coma
• hallucination
• lightheadedness or fainting
• mood or other mental changes
• muscle tremors
• not breathing
• rapid, deep breathing
• restlessness
• slow or irregular heartbeat
• stomach cramps
• sudden fainting
• sweating

Other side effects of Caldolor

Some side effects of ibuprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Continuing ringing or buzzing or other unexplained noise in ears
• hearing loss
• nervousness

Rare

• Crying
• depersonalization
• discouragement
• dry eyes
• dysphoria
• euphoria
• feeling sad or empty
• lack of appetite
• loss of interest or pleasure
• mental depression
• paranoia
• quick to react or overreact
• rapidly changing moods
• runny nose
• sleepiness or unusual drowsiness
• sleeplessness
• sneezing
• stuffy nose
• trouble concentrating
• trouble sleeping
• unable to sleep

For Healthcare Professionals

Applies to ibuprofen: compounding powder, intravenous solution, oral capsule, oral suspension, oral tablet, oral tablet chewable.

General

The most frequently reported adverse effects were gastrointestinal (GI) in nature and included nausea, vomiting, flatulence, and diarrhea.

Patent Ductus Arteriosus: The most frequently reported adverse effects were sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, and respiratory failure.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 57%), vomiting (up to 22%), flatulence (up to 16%), diarrhea (up to 10%)

Common (1% to 10%): Dyspepsia, abdominal discomfort, epigastric pain, heartburn, abdominal distress, indigestion, constipation, abdominal cramps/pain, fullness of GI tract, bloating, GI hemorrhage, melena

Uncommon (0.1% to 1%): Abdominal distention, dyspepsia, gastritis

Very rare (less than 0.01%): Peptic ulcer, perforation, hematemesis, mouth ulceration, exacerbation of colitis, exacerbation of Crohn's disease

Frequency not reported: Dry mouth, duodenitis, esophagitis, gastric ulcer, duodenal ulcer, GI bleeding, glossitis, rectal bleeding, stomatitis, eructation, gingival ulcer, pancreatitis

Patent Ductus Arteriosus:

Very common (10% or more): GI disorders non-necrotizing enterocolitis (22%)

Common (1% to 10%): Necrotizing enterocolitis, intestinal perforation

Frequency not reported: Abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia

Postmarketing reports: GI perforation^[Ref]

Cardiovascular

Very common (10% or more): Hemorrhage (up to 10%), hypertension (10%), hypotension (10%)

Very rare (less than 0.01%): Cardiac failure

Frequency not reported: Congestive heart failure, tachycardia, arrhythmia, myocardial infarction, palpitations, vasculitis, sinus bradycardia, angina pectoris, thrombotic events

Patent Ductus Arteriosus:

Frequency not reported: Tachycardia, cardiac failure, hypotension^[Ref]

Nervous system

Very common (10% or more): Headache (up to 12%)

Common (1% to 10%): Dizziness, nervousness

Very rare (less than 0.01%): Cerebrovascular accident

Frequency not reported: Syncope, drowsiness, paresthesia, somnolence, tremors, convulsions, coma

Patent Ductus Arteriosus:

Common (1% to 10%): Intraventricular hemorrhage, periventricular hemorrhage

Frequency not reported: Convulsions^[Ref]

Renal

Very rare (less than 0.01%): Acute renal failure, renal papillary necrosis, interstitial nephritis, nephrotic syndrome, renal failure, renal insufficiency

Frequency not reported: Cystitis, azotemia, creatinine clearance decreased, glomerulitis, tubular necrosis, nephrotoxicity

Patent Ductus Arteriosus:

Very common (10% or more): Renal events (21%)

Uncommon (0.1% to 1%): Acute renal failure^[Ref]

The number of total renal events in preterm infants within 30 days of therapy following IV use was 21% and included increased blood urea (7%), renal insufficiency/impairment (6%), reduced urine output (3%), increased blood creatinine (3%), renal failure (1%), and increased blood urea with hematuria (1%).^[Ref]

Hematologic

The incidence of total bleeding events within 30 days of therapy with IV use in preterm infants was 32%. This percentage included grade 1 and 2 intraventricular hemorrhage (15%), grade 3 and 4 intraventricular hemorrhage (15%), and other bleeding (6%).^[Ref]

Very common (10% or more): Anemia (up to 36%), eosinophilia (up to 26%), neutropenia (up to 13%), thrombocythemia (up to 10%)

Common (1% to 10%): Hemoglobin decreased

Very rare (less than 0.01%): Leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, pancytopenia, hematocrit decreased

Frequency not reported: lymphadenopathy, bleeding episodes

Patent Ductus Arteriosus:

Very common (10% or more): Anemia (32%), total bleeding (32%), intraventricular hemorrhage (29%), Neutropenia, thrombocytopenia^[Ref]

Dermatologic

Common (1% to 10%): Rash, maculopapular rash, pruritus

Very rare (less than 0.01%): Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis

Frequency not reported: Ecchymosis, purpura, alopecia, sweating, photosensitivity, angioedema, exfoliative dermatitis, urticaria, vesiculobullous eruptions, Henoch Schonlein vasculitis

Patent Ductus Arteriosus:

Very common (10% or more): Skin lesion/irritation (16%)^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 19%), hypoproteinemia (up to 13%), blood urea increased (10%), hypernatremia (10%), hypoalbuminemia (10%)

Common (1% to 10%): Appetite decreased, fluid retention

Frequency not reported: Appetite changes, hyperglycemia, hypoglycemic reaction, acidosis

Patent Ductus Arteriosus:

Very common (10% or more): Hypoglycemia (12%), hypocalcemia (12%), blood creatinine increased, blood sodium decreased

Common (1% to 10%): Hypernatremia

Frequency not reported: Feeding problems, hyperglycemia^[Ref]

Other

Very common (10% or more): Bacteremia (13%), blood LDH increased (up to 10%)

Common (1% to 10%): Peripheral edema, wound hemorrhage, tinnitus, hearing impairment, edema, fatigue

Very rare (less than 0.01%): Aseptic meningitis, vertigo, exacerbation of infection-related inflammations

Frequency not reported: Fever, infection, sepsis, weight changes, asthenia, malaise, pseudo-tumor, hearing loss, drowsiness

Patent Ductus Arteriosus:

Very common (10% or more): Sepsis (43%)

Common (1% to 10%): Edema, fluid retention

Frequency not reported: Various infections^[Ref]

Respiratory

Very common (10% or more): Bacterial pneumonia (up to 10%)

Common (1% to 10%): Cough

Very rare (less than 0.01%): Asthma, bronchospasm, dyspnea, wheezing

Frequency not reported: Apnea, respiratory depression, pneumonia, rhinitis, epistaxis

Patent Ductus Arteriosus:

Very common (10% or more): Apnea (28%), respiratory infection (19%), respiratory failure (10%), bronchopulmonary dysplasia

Common (1% to 10%): Atelectasis, pulmonary hemorrhage

Uncommon (0.1% to 1%): Hypoxemia

Postmarketing reports: Pulmonary hypertension^[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis, jaundice

Frequency not reported: Hepatorenal syndrome, liver necrosis, liver failure, abnormal liver function tests

Patent Ductus Arteriosus:

Frequency not reported: Cholestasis, jaundice^[Ref]

Hypersensitivity

Hypersensitivity reactions have been reported and may consist of any of the following: a syndrome of abdominal pain, fever, chills, nausea, vomiting, and anaphylaxis; respiratory tract reactivity comprising bronchospasm, asthma/aggravated asthma, or dyspnea; skin reactions, which rarely included exfoliative and bullous dermatoses, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, pruritus, and urticaria.^[Ref]

Frequency not reported: Anaphylactoid reactions, hypersensitivity reaction^[Ref]

Ocular

Very rare (less than 0.01%): Visual disturbances

Frequency not reported: Blurred vision, amblyopia, diminished vision, scotomata, changes in color vision, conjunctivitis, dry eyes, diplopia, optic neuritis, cataracts, optic neuritis, toxic optic neuropathy^[Ref]

Musculoskeletal

Frequency not reported: Lupus erythematosus syndrome^[Ref]

Psychiatric

Frequency not reported: Anxiety, confusion, depression, dream abnormalities, insomnia, emotional lability, hallucinations^[Ref]

Genitourinary

Common (1% to 10%): Urinary retention

Very rare (less than 0.01%): Proteinuria, hematuria

Frequency not reported: Dysuria, oliguria, polyuria, menorrhagia

Patent Ductus Arteriosus:

Very common (10% or more): Oliguria, hematuria

Common (1% to 10%): Urinary tract infection^[Ref]

Immunologic

Frequency not reported: Serum sickness^[Ref]

Local

Common (1% to 10%): Infusion site pain

Postmarketing reports: Transient sensation of burning in mouth/throat

Patent Ductus Arteriosus:

Frequency not reported: Injection site reactions^[Ref]

Endocrine

Frequency not reported: Gynecomastia

Patent Ductus Arteriosus:

Common (1% to 10%): Adrenal insufficiency^[Ref]