IBU Side Effects

Generic name: ibuprofen

Note: This page contains information about the side effects of ibuprofen. Some of the dosage forms included on this document may not apply to the brand name IBU.

For the Consumer

Applies to ibuprofen: oral capsule, oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable

In addition to its needed effects, some unwanted effects may be caused by ibuprofen (the active ingredient contained in IBU). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with ibuprofen may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Applies to ibuprofen: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by ibuprofen (the active ingredient contained in IBU). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking ibuprofen:

More common:

• Abdominal cramps
• abdominal pain or swelling
• anxiety
• black, tarry stools
• bladder pain
• blood in eyes
• bloody or cloudy urine
• blue lips, fingernails, or skin
• bruising or purple areas on skin
• bumps on skin
• burning, itching, redness, or stinging of skin
• chills
• cold sweats
• coma
• cool, pale skin
• cough
• coughing up blood
• darkening of skin
• decreased alertness
• decreased frequency or amount of urine
• diarrhea
• difficulty in breathing
• fast heartbeat
• fever
• high blood pressure
• increased blood pressure
• increased hunger
• increased thirst
• indigestion
• irregular, fast or slow, or shallow breathing
• irregular heartbeats
• irritability
• joint pain or swelling
• loss of appetite
• muscle cramps in hands, arms, feet, legs, or face
• muscle twitching
• nausea or vomiting
• nervousness
• nosebleeds
• passing of gas
• rapid, shallow breathing
• rash on skin
• restlessness
• seizures
• shakiness
• shortness of breath
• sneezing
• stomach pain, fullness, or discomfort
• swelling of face, fingers, feet or lower legs
• tremor
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known:

• Bleeding, blistering, coldness, discoloration of skin, hives, infection, inflammation, itching, lumps, pain, rash, redness, scarring, soreness, swelling, tenderness, ulceration, or warmth at injection site
• bleeding gums
• blood in stools
• chest pain or discomfort
• clay-colored stools
• dark urine
• dilated neck veins
• dry mouth
• extreme fatigue
• fast, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fruit-like breath odor
• pinpoint red spots on skin
• severe constipation
• severe vomiting
• stomach upset
• sweating
• swelling of abdominal or stomach area
• tenderness in stomach area
• ulcers, sores, or white spots in mouth
• unexplained weight loss
• unpleasant breath odor
• vomiting of blood
• weight gain
• wheezing
• yellow eyes or skin

Symptoms of overdose:

• Agitation
• change in consciousness
• drowsiness
• lethargy
• loss of consciousness
• rapid weight gain
• stupor
• swelling of face, ankles, or hands

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

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]

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]

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]

Not all side effects for IBU may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.