Plain-language summary, compiled from the cited regulatory records
Nabumetone is a medication classified as a non-steroidal anti-inflammatory agent [1]. It is approved for the relief of signs and symptoms associated with osteoarthritis and rheumatoid arthritis [1].
When considering the use of nabumetone, it is important to carefully weigh the potential benefits against the risks, along with alternative treatment options [1]. The recommended approach is to use the lowest effective dose for the shortest duration necessary to achieve individual patient treatment goals [1].
In the past 12 months, there have been 112 adverse event reports associated with nabumetone [2]. Among the frequently reported events were drug ineffectiveness, the need for surgery, nausea, off-label use, and pain [2].
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised November 21, 2025[1]
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
How to take
GBUnited Kingdom· MHRA
3 products
Uses
GBOfficial regulatory label· revised May 1, 2026[2]
Nabumetone Tablets are indicated for use in osteoarthritis and rheumatoid arthritis requiring anti-inflammatory and analgesic treatment.
How to take
GB
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
2 Geriatrics 05/2022
How to take
CAOfficial regulatory label· revised March 22, 2025
Drug interactions
Known interactions involving Nabumetone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 455. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]FDA DailyMed · 0653b873-b74b-4e… · revised November 21, 2025 [PDF]
[2]MHRA (UK) · PL001420450 · revised May 1, 2026
[3]Health Canada (DPD) · 02238369 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
USOfficial regulatory label· revised November 21, 2025[1]
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
After observing the response to initial therapy with nabumetone tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Osteoarthritis and Rheumatoid Arthritis:
The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone tablets can be given in either a single or twice-daily dose.
Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment (see WARNINGS, Renal Effects ). Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 112 reports total. [4]
Drug Ineffective 7
Surgery 7
Nausea 6
Off Label Use 6
Pain 6
Vomiting 6
Arthralgia 5
Product Dose Omission Issue 5
Condition Aggravated 4
Diarrhoea 4
Dizziness 4
Fatigue 4
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised November 21, 2025[1]
ADVERSE REACTIONS
Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies.
Of the 1,677 patients who received nabumetone during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer.
The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.
Incidence ≥1%— Probably Causally Related Gastrointestinal:
Edema * ———————————————————————————————————— * Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked.
Incidence < 1% — Probably Causally Related † Gastrointestinal:
Anaphylactoid reaction, anaphylaxis , angioneurotic edema ———————————————————————————————————— † Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.
USOfficial regulatory label· Warnings and precautions· revised November 21, 2025[1]
WARNINGS CARDIOVASCULAR EFFECTS
Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as Nabumetone, increases the risk of serious gastrointestinal (GI) events [see WARNINGS ].
Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG [see Contraindications ]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised November 21, 2025[1]
CONTRAINDICATIONS
Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions , and PRECAUTIONS, General, Preexisting Asthma ). Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
This is not medical advice. Consult a qualified healthcare professional.
The usual starting dose is 1g (two tablets) per day taken as a single daily dose at bedtime. For severe or persistent symptoms, or during acute exacerbations an additional 500mg- 1g may be given as a morning dose.
Elderly:
Blood levels may be higher in elderly patients because of accumulation of the drug as a result of reduced metabolism and elimination by the liver and kidneys. The recommended daily dose of 1g should not be exceeded in this age group and in some cases 500mg may give satisfactory relief.
The risk of serious consequences of adverse effects is increased in the elderly. The lowest dose possible should be used and patients should be monitored for gastrointestinal bleeding for 4 weeks following initiation of therapy with nabumetone.
Children:
Not recommended as there is no clinical data. Method of Administration For oral administration. Nabumetone should be administered with or after food to minimise the risk of gastrointestinal adverse effects. 4).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 1, 2026[2]
4). Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports.
Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo and comparator groups has not been taken into account in estimation of these frequencies. Rare and very rare events were generally determined from spontaneous data.
Blood and lymphatic system disorders Very Rare:
Not known: Thrombocytopenia Anaemia (incl. 4)) Eye disorders Uncommon: Abnormal vision, eye disorder Ear and labyrinth disorders Common: Tinnitus, ear disorder Vascular disorders Common: Increases in blood pressure Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, respiratory disorder, epistaxis Very rare: Interstitial pneumonitis Gastrointestinal disorders Common: Diarrhoea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence Uncommon: Duodenal ulcer, GI bleeding, gastric ulcer GI disorder, melena, vomiting, stomatitis, dry mouth Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature.
4). 4) have been reported following administration. Less frequently, gastritis has been observed.
Hepatobiliary disorders Very rare:
Hepatic failure, jaundice Skin and subcutaneous tissue disorders Common: Rash, pruritus Uncommon: Photosensitivity, urticaria, sweating Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia Musculoskeletal and connective tissue disorders Uncommon: Myopathy Renal and urinary disorders Uncommon: Urinary tract disorder Very rare: Renal failure, nephrotic syndrome Reproductive system and breast disorders Very rare: Menorrhagia General disorders and administration site conditions Common: Oedema Uncommon: Asthenia, fatigue Investigations Uncommon: Elevated liver function tests Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 1, 2026[2]
The use of nabumetone with concomitant NSAIDs, including cyclooxygenase- 2 selective inhibitors, should be avoided. Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
2). Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
3) and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI peptic disease, particularly when elderly, should be alerted to report any unusual abdominal symptoms indicative for ulceration (especially GI bleeding), particularly in the initial stages of treatment.
5). When GI bleeding or ulceration occurs in patients receiving nabumetone, the treatment should be withdrawn. 8). 8%. Although these figures seem low, the prescribing physician should be aware that these ADR can occur even in the absence of previous peptic disease.
Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and oedema have been reported in association with NSAID therapy.
g. myocardial infarction or stroke). There is insufficient data to exclude such a risk for nabumetone. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with nabumetone after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). 8). At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, nabumetone should be withdrawn immediately and an alternative treatment considered (as appropriate).
Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first two months of treatment. Nabumetone should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 1, 2026[2]
1. • Nabumetone must not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking acetylsalicylic acid or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
• Nabumetone is contraindicated in patients with severe hepatic failure. • Nabumetone is contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. • Nabumetone is contraindicated in patients with active, or history of recurrent, peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Nabumetone is contraindicated in the third trimester of pregnancy and in nursing mothers. • Nabumetone is contraindicated in patients with severe heart failure, and in patients with current cerebrovascular or other haemorrhage.
This is not medical advice. Consult a qualified healthcare professional.
1 Dosing Considerations Use of NABUMETONE should be limited to the lowest effective dose for the shortest possible duration of treatment (see 1 INDICATIONS). 2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment Osteoarthritis and Rheumatoid Arthritis Adults The starting and usual dose is 1000 mg daily taken as a single dose.
The dosage may be increased to 1500 mg or 2000 mg per day given either as a single dose or in two divided doses. 3 Pharmacokinetics, Table 4). For this reason, dosage adjustments during therapy should not be made more frequ ently than at one-week intervals, except in the case of side effects.
3 Pediatrics). 4 Geriatrics).
Renal impairment:
In patients with impaired renal function, lower doses should be considered, patients should be closely monitored, and dosage level adjustments should be made on an individual basis. 4 Drug-Drug Interactions). 5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see 2 CONTRAINDICATIONS).
Hepatic impairment:
Patients with impaired hepatic function should be carefully monitored and kept at the minimal effective daily dosage. 4 Drug-Drug Interactions). NABUMETONE is contraindicated in patients with severe hepatic impairment or active liver disease (see 2 CONTRAINDICATIONS).
4 Administration NABUMETONE should be taken immediately after a meal or with food or milk. Tablets should be swallowed whole, not crushed or chewed. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember.
If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule. The patient should be instructed not to take 2 doses at the same time.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
1 Adverse Reaction Overview The most common adverse reactions encountered with NSAIDs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred particularly in the elderly (see Gastrointestinal).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse reaction information was derived from blinded controlled and open -labelled clinical trials and from worldwide marketing experience.
Over 6,000 patients have been treated with nabumetone in clinical trials, and over 49,000 patients included in post-marketing surveillance studies and NABUMETONE (Nabumetone tablets) Page 24 of 53 nabumetone has been prescribed extensively in those countries where the drug has received registration clearance.
In large scale post-marketing studies the adverse event profile was highly consistent with the profile seen in clinical trials of nabumetone. The pattern of adverse events remained similar in patients treated with nabumetone for several years, similar in patients taking 1 to 2 g doses, and was similar in patients aged <65 or ≥65 years.
Information on adverse experiences observed in US clinical studies is presented below. Of the 1,677 patients who received nabumetone during US clinical trials, 1,524 were treated for at least one month, 1,327 for at least three months, 929 for at least a year, and 750 for at least two years.
Over 300 patients have been treated for five years or longer. The most frequently reported adverse reactions were related to the gastrointestinal tract. They were diarrhea, dyspepsia, and abdominal pain. 1 % (abdominal pain) during the double blind phase of the US clinical trials involving 930 patients treated with nabumetone for up to 6 months.
8% at two years. The following table displays adverse events reported in long-term clinical trial follow-up involving treatment for up to 8 years. Where available, percentages are based upon the total number of observations, thus patients reporting multiple incidents of an adverse event have been recorded for each occurrence.
Causal relationship to nabumetone has not necessarily been established for all of the events listed below. 3 Less Common Clinical Trial Adverse Reactions Less Common Clinical Trial Adverse Drug Reactions (<1%): The following adverse events were reported in long-term clinical trial follow-up involving treatment for up to 8 years.
01% are based on spontaneous reports from worldwide marketing experience. Where available, percentages are based upon the total number of observations, thus patients reporting multiple incidents of an adverse event have been recorded for each occurrence.
Causal relationship to nabumetone has not necessarily been established for all of the events listed below. 01). 1%). 2%). 2%). 01%). 01%). 01). 1%). 1%). 01%). 1%), […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
4 Geriatrics 05/2022 NABUMETONE (Nabumetone tablets) Page 4 of 53 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ......................................................................................................
2 TABLE OF CONTENTS ........................................................................................................................ 4 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................
10 7 WARNINGS AND PRECAUTIONS .............................................................................................. 1 Special Populations ...........................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of nabumetone tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If nabumetone tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension:
NSAIDs, including nabumetone tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.
NSAIDs, including nabumetone tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients.
In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
, diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] [see Drug Interactions ]. Avoid the use of nabumetone tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If nabumetone tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Gastrointestinal Effects, Risk of Ulceration, Bleeding, and Perforation:
NSAIDs, including nabumetone tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Only 1 in 5 patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for 1 year.
These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. 3%) at 2 years. In patients with active peptic ulcer, physicians must weigh the benefits of therapy with nabumetone against possible hazards, institute an appropriate ulcer treatment regimen and monitor the patients’ progress carefully.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors.
Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.
Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration.
Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out.
For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Renal Effects:
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.
In these patients, administration of an NSAID results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in a reduction of renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease:
No information is available from controlled clinical studies regarding the use of nabumetone tablets in patients with advanced renal disease. Therefore, treatment with nabumetone tablets is not recommended in these patients with advanced renal disease.
If nabumetone tablets therapy must be initiated, close monitoring of the patient’s renal function is advisable. Because nabumetone undergoes extensive hepatic metabolism, no adjustment of the dosage of nabumetone is generally necessary in patients with mild renal insufficiency; however, as with all NSAIDs, patients with impaired renal function should be monitored more closely than patients with normal renal function (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Renal Insufficiency ).
In subjects with moderate renal impairment (creatinine clearance 30 to 49 mL/min) there is a 50% increase in unbound plasma 6MNA and dose adjustment may be warranted. The oxidized and conjugated metabolites of 6MNA are eliminated primarily by the kidneys.
Anaphylactoid Reactions:
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to nabumetone tablets. Nabumetone tablets should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, General, Preexisting Asthma ).
Emergency help should be sought in cases where an anaphylactoid reaction occurs. Serious Skin Reactions NSAIDs, including nabumetone can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of NABUMETONE TABLET at the first appearance of skin rash or any other sign of hypersensitivity.
NABUMETONE TABLET is contraindicated in patients with previous serious skin reactions to NSAIDs (see CONTRAINDICATIONS ) . Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as nabumetone tablets.
Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis.
Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, discontinue nabumetone tablets and evaluate the patient immediately.
Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus :
Avoid use of NSAIDs, including nabumetone tablets, in pregnant women at about 30 weeks gestation and later. NSAIDs including nabumetone tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment :
Use of NSAIDs, including nabumetone tablets, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit nabumetone tablets use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if nabumetone tablets treatment extends beyond 48 hours.
Discontinue nabumetone tablets if oligohydramnios occurs and follow up according to clinical practice [see PRECAUTIONS; Pregnancy ].
If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of nabumetone, treatment with nabumetone must not be restarted in this patient at any time. Impaired female fertility The use of nabumetone may impair female fertility and is not recommended in women attempting to conceive.
In women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of nabumetone should be considered. Others NSAIDs may mask the signs or symptoms of an infection (fever, pain and swelling). Cases of blurred vision or reduced visual activity have been reported with NSAID use, including nabumetone.
Patients presenting with these events must be submitted to ophthalmological examination. Caution should be used when administering nabumetone to patients with: • Previous acetylsalicylic acid- or other NSAID-induced asthma, urticaria, or other allergic-type reactions.
Since fatal asthma attacks have been reported in such patients receiving other NSAIDs, the first administration of nabumetone should be medically supervised. 8). • Severe hepatic impairment: As with other NSAIDs, abnormalities of liver function tests, rare cases of jaundice and hepatic failure (some of them with fatal outcomes), have been reported.
A patient with signs/symptoms suggesting liver dysfunction, or who has experienced an […]
1 Pregnant Women ........................................................................................................... 2 Breast-feeding ................................................................................................................