Note: This document contains side effect information about ibuprofen. Some dosage forms listed on this page may not apply to the brand name NeoProfen.
Applies to ibuprofen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable. Other dosage forms:
- intravenous solution
Warning
Oral route (Tablet; Suspension; Capsule, Liquid Filled; Tablet, Chewable)
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
Serious side effects of NeoProfen
Along with its needed effects, ibuprofen (the active ingredient contained in NeoProfen) 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 NeoProfen
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]