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NeoProfen Side Effects

Generic name: ibuprofen

Medically reviewed by Drugs.com. Last updated on Feb 6, 2024.

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:

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

Less common

Rare

Symptoms of overdose

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

Rare

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

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]

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]

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]

Frequently asked questions

References

1. (2002) "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn

2. (2004) "Product Information. Ibuprofen (ibuprofen)." Par Pharmaceutical Inc

3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

4. (2006) "Product Information. NeoProfen (ibuprofen)." Ovation Pharmaceuticals Inc

5. Cerner Multum, Inc. "Australian Product Information."

6. (2009) "Product Information. Caldolor (ibuprofen)." Cumberland Pharmaceuticals Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.