Nabumetone

Nabumetone is indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

• Nabumetone is available under the following different brand names: Relafen.

Dosage Forms and Strengths

Tablet

• 500 mg
• 750 mg

Dosage Considerations – Should be Given as Follows:

Pediatric: Not recommended

Osteoarthritis

• 1000 mg orally once daily initially; maintenance: 1000-2000 mg/day orally in single daily dose or divided every 12 hours; not to exceed 2000 mg/day

Rheumatoid Arthritis

• 1000 mg orally once daily initially; maintenance: 1000-2000 mg/day orally in single daily dose or divided every 12 hours; not to exceed 2000 mg/day

Dosage Modifications

• Moderate renal impairment (CrCl: 30-49 mL/min): 750 mg/day initially; not to exceed 1500 mg/day
• Severe renal impairment (CrCl: less than 30 mL/min): 500 mg/day initially; not to exceed 1000 mg/day

Common side effects of Nabumetone include:

• Diarrhea
• Indigestion/heartburn
• Abdominal pain
• Constipation
• Dizziness
• Swelling (edema)
• Gas (flatulence)
• Headache
• Nausea
• Positive stool guaiac
• Skin itching
• Rash
• Ringing in the ears (tinnitus)
• Dry mouth
• Fatigue
• Stomach or abdominal pain or upset
• Increased sweating
• Insomnia
• Nervousness
• Drowsiness
• Swelling and sores inside the mouth
• Vomiting
• Bloating
• Blurred vision

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe Interactions of nabumetone include:
  • None
• Serious Interactions of nabumetone include:
  • apixaban
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • ketorolac
  • ketorolac intranasal
  • lisinopril
  • methotrexate
  • moexipril
  • pemetrexed
  • perindopril
  • quinapril
  • ramipril
  • tacrolimus
  • trandolapril
• Nabumetone has moderate interactions with at least 229 different drugs.
• Nabumetone has mild interactions with at least 79 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

Cardiovascular risk

• NSAIDs increase the risk of 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

Gastrointestinal risk

• NSAIDs increase the risk of 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

This medication contains nabumetone. Do not take Relafen if you are allergic to nabumetone or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Absolute: Aspirin allergy, severe renal impairment; perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
• Relative: Duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus, ulcerative colitis, late pregnancy (may cause premature closure of ductus arteriosus)

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Nabumetone?"

Long-Term Effects

• Long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs) may result in renal papillary necrosis and another renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
• See "What Are Side Effects Associated with Using Nabumetone?"

Cautions

• Use caution in asthma (bronchial), bleeding disorders, cardiac disease, hepatic impairment, hypertension, and renal impairment
• May not be sufficiently activated in patients with hepatic dysfunction; use with caution
• Long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs) may result in renal papillary necrosis and another renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
• Risk of serious gastrointestinal (GI) toxicity, including bleeding, ulcers, and perforation
• May cause drowsiness, dizziness, blurred vision, and other neurologic effects
• May decrease platelet adhesion and aggregation, prolonging bleeding time; monitor closely patients with a history of coagulation disorders
• May increase risk of hyperkalemia
• May cause photosensitivity reactions
• Severe skin reactions may occur; discontinue use at the first sign of rash
• Heart Failure (HF) risk
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to trigger heart failure by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDs should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy and Lactation

• Use nabumetone with caution during pregnancy if benefits outweigh risks
• Animal studies show risk and human studies are not available or neither animal nor human studies were done
• There is positive evidence of human fetal risk if nabumetone is used for prolonged periods or near term (premature closure of ductus arteriosus)
• Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to non-aspirin NSAIDs
• during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls
• It is unknown whether nabumetone is excreted in breast milk; its effect on infants is unknown
• Do not give nabumetone to nursing mothers