ibuprofen (NSAID)

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used to treat inflammation, fever and mild to moderate pain from conditions such as common cold, headache, toothache, menstrual cramps, muscular pains, and joint pain and inflammation (arthritis).

Intravenous ibuprofen is used to treat patent ductus arteriosus (PDA), a condition in newborn babies in which a fetal connection between the aorta and pulmonary artery that normally closes at birth, remains open.

Ibuprofen works by blocking the activity of enzymes known as cyclooxygenases (COX-1 and COX-2), essential for biosynthesis of prostaglandin. Prostaglandins are fatty compounds that regulate many processes in the body including inflammation, blood flow and clotting processes, smooth muscle function, and female reproductive cycle.

By inhibiting prostaglandin synthesis, ibuprofen:

• Inhibits the movement and aggregation of inflammatory cells
• Inhibits the release of proinflammatory proteins (cytokines)
• Inhibits platelet aggregation, interfering with blood clotting function
• Promotes the closure of patent ductus arteriosus

Lower dosages of ibuprofen to treat minor pains are available over the counter, while dosages of 400 mg and above require prescription. Ibuprofen is used to treat the following:

Adult

• Pain and fever
• Painful menstruation (dysmenorrhea)
• Inflammatory disease
• Osteoarthritis
• Rheumatoid arthritis

Pediatric

• Pain and fever
• Juvenile idiopathic arthritis
• Patent ductus arteriosus
• Cystic fibrosis, a genetic disorder that affects fluid-secreting cells (off-label)

• Do not take/administer ibuprofen if you/they have hypersensitivity to ibuprofen, aspirin or other NSAIDs
• Do not administer ibuprofen to preterm infants with:
  • Untreated proven or suspected infection
  • Bleeding with active intracranial hemorrhage or gastrointestinal (GI) bleed
  • Low platelet count (thrombocytopenia)
  • Coagulation defects
  • Proven or suspected intestinal inflammation (necrotizing enterocolitis)
  • Significant renal impairment
  • Congenital heart disease where patency of the ductus arteriosus is necessary for pulmonary or systemic blood flow
• Do not use for perioperative pain in coronary artery bypass graft (CABG) surgery

Cardiovascular risk:

• Ibuprofen may increase the risk of serious cardiovascular clotting (thrombotic) events, heart attack (myocardial infarction), and stroke, which can be fatal
• Risk for the above may increase with duration of use
• Do not use ibuprofen in patients with existing cardiovascular disease or risk factors for such disease, they may have greater cardiovascular risk
• Ibuprofen can lead to new onset or exacerbation of high blood pressure (hypertension)

Gastrointestinal risk:

• Ibuprofen can cause serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
• GI adverse events may occur at any time during use and without warning symptoms
• Elderly patients are at greater risk for serious GI events

Common side effects of ibuprofen may include:

• Gastrointestinal effects such as:
  • Nausea
  • Vomiting
  • Upper abdominal (epigastric) pain
  • Heartburn
  • Abdominal distress
  • Diarrhea
  • Indigestion (dyspepsia)
  • Constipation
  • Abdominal cramps
  • Bloating and flatulence
• Dizziness
• Headache
• Nervousness
• Ringing in the ears (tinnitus)
• Rash
• Itching (pruritus)
• Reduced appetite
• Fluid retention
• Swelling (edema)

Less common side effects may include:

• Blood in stool
• Gastrointestinal inflammation (gastritis, hepatitis, pancreatitis)
• Jaundice
• Depression
• Insomnia
• Confusion
• Hearing loss
• Vision disturbances
• Dry eyes
• Dry mouth and gum ulcers
• Nasal inflammation (rhinitis)
• Bronchospasm
• Elevated blood pressure
• Palpitations
• Blood disorders such as:
  • Low red blood cell count due to reduced red cell production (aplastic anemia)
  • Anemia from rapid destruction of red cells (hemolytic anemia)
  • Low levels of neutrophil, a type of immune cell (neutropenia)
  • Low levels of granulocytes, immune cells with granules (agranulocytosis)
  • Low platelet count (thrombocytopenia)
  • High level of eosinophils, a type of immune cell (eosinophilia)
• Reduced creatine clearance
• Bladder inflammation (cystitis)
• Increased urine output
• Blood in urine (hematuria)
• Elevated blood urea nitrogen (BUN)

Rare severe side effects may include:

• Gastrointestinal bleeding
• Gastrointestinal perforation
• Aseptic meningitis with fever and coma
• Acute renal failure
• Congestive heart failure
• Severe skin reactions including:
  • Exfoliative dermatitis
  • Stevens-Johnson syndrome
  • Toxic epidermal necrolysis
• Severe allergic reaction (anaphylaxis)

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet

• 100mg
• 200mg
• 400mg (Rx)
• 600mg (Rx)
• 800mg (Rx)

Capsule

• 200mg

Tablet, chewable

• 50mg
• 100mg

Oral suspension

• 100mg/5mL
• 40mg/mL

Adult

Pain/Fever/Dysmenorrhea

• Over-the-counter (OTC): 200-400 mg taken orally once every 4-6 hours; not to exceed 1.2 g unless directed by a physician
• Prescription: 400-800 mg taken orally or intravenously (IV) once every 6 hours

Inflammatory Disease

• 400-800 mg taken orally once every 6-8 hours; not to exceed 3.2 g/day

Osteoarthritis

• 300 mg, 400 mg, 600 mg, or 800 mg taken orally once every 6-8 hours; not to exceed 3.2 g/day
• Monitor for gastrointestinal (GI) risks

Rheumatoid Arthritis

• 300 mg, 400 mg, 600 mg, or 800 mg taken orally once every 6-8 hours; not to exceed 3200 mg/day
• Monitor for GI risks

Dosage Modifications

• Significantly impaired renal function: Monitor closely; consider reduced dosage if warranted
• Severe hepatic impairment: Avoid use

Pediatric

Fever

• Children 6 months to 12 years: 5-10 mg/kg/dose taken orally once every 6-8 hours; not to exceed 40 mg/kg/day 

Pain

• 4-10 mg/kg/dose taken orally once every 6-8 hours; not to exceed 40 mg/kg/day

Juvenile Idiopathic Arthritis

• 30-50 mg/kg/24 hours taken orally once every 8 hours; not to exceed 2.4 g/day

Patent Ductus Arteriosus

• See ibuprofen IV (intravenous) drug monograph

Cystic Fibrosis (Off-label)

• Younger than 4 years: Safety and efficacy not established
• 4 years of age and older: taken orally once every 12 hours, adjusted to maintain serum levels of 50-100 mcg/mL; may slow disease progression in younger patients with mild lung disease

Dosing Considerations

• The potential toxic dose in children younger than 6 years is 200 mg/kg

• Overdose must be treated with symptomatic and supportive care, such as administering activated charcoal and/or inducing vomiting (emesis).
• It may be beneficial to administer alkali and increase urine output because ibuprofen is acidic and is excreted in the urine.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of ibuprofen include: None
• Serious interactions of ibuprofen include:
  • apixaban
  • aspirin
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • ketorolac
  • lisinopril
  • methotrexate
  • moexipril
  • pemetrexed
  • perindopril
  • quinapril ramipril
  • tacrolimus
  • trandolapril
• Ibuprofen has moderate interactions with at least 239 different drugs.
• Ibuprofen has mild interactions with at least 116 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies of ibuprofen in pregnancy, labor and delivery.
• Avoid using ibuprofen up to 20 weeks of gestation. Animal studies indicate an increased risk for loss of pregnancy in early stages because ibuprofen inhibits the synthesis of prostaglandin.
• Limit dose and duration of use between about 20 and 30 weeks of gestation.
• Avoid ibuprofen use at about 30 weeks of gestation and later in pregnancy, it may cause premature closure of ductus arteriosus and fetal renal dysfunction.
• No lactation studies have been conducted. Ibuprofen may be excreted in breast milk at extremely low levels. Ibuprofen has a short half-life and is considered safe in infants in doses much higher than those excreted in breast milk.

• Ibuprofen can cause fluid retention and edema and must be used with caution in patients with edema or congestive heart failure.
• Long-term administration of NSAIDs may result in kidney damage or injury; patients at the greatest risk include elderly individuals, those with impaired renal function, low blood volume (hypovolemia), heart failure, liver dysfunction, or salt depletion; and those taking medication such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers.
• NSAIDS, except aspirin, increase risk of heart attack, heart failure, and stroke, which can be fatal; the risk is higher if patients use more than it was directed or for longer than needed.
• Use with caution in asthma (bronchial), cardiac disease, congestive heart failure (CHF), hepatic or renal impairment, hypertension, bleeding disorders, duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus (SLE), ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus).
• Fever, rash, abdominal pain, nausea, liver dysfunction, and meningitis have occurred in patients with collagen-vascular disease, especially SLE.
• Ibuprofen (Junior Advil) for children may cause severe and persistent sore throat.
• Higher than recommended doses may cause stomach bleeding in children.
• Ibuprofen may increase the risk of elevated potassium in blood (hyperkalemia), especially in renal disease, patients with diabetes, the elderly, and when used simultaneously with other medications capable of inducing hyperkalemia.
• Ibuprofen can cause severe skin reactions such as Stevens-Johnson syndrome.
• Ibuprofen may cause drowsiness and dizziness; may impair ability to drive or operate heavy machinery.
• Ibuprofen may cause blurred vision, partial loss of vision/blind spot or changes in color vision.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in patients taking NSAIDs, some of which have been fatal or life-threatening. DRESS may present with fever, rash, swollen lymph nodes (lymphadenopathy), and/or facial swelling.