NABUMETONE (nabumetone)

There are 6 contraindications. Absolute contraindication.

Contraindication List
Aspirin exacerbated respiratory disease
Cerebrovascular accident
History of roux-en-Y gastric bypass
Post-operative from CABG surgery
Pregnancy
Renal transplant

There are 17 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Alcohol use disorder
Chronic heart failure
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Gastrointestinal hemorrhage
Gastrointestinal perforation
Gastrointestinal ulcer
History of kidney donation
Increased risk of bleeding
Increased risk of bleeding due to coagulation disorder
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Nephrectomy
Peptic ulcer
Systemic mastocytosis
Thrombotic disorder
Tobacco smoker

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Hypertension

There are 65 severe adverse reactions.

More Frequent	Less Frequent
None.	Edema Gastritis Skin rash Tinnitus

Rare/Very Rare

Abnormal hepatic function tests Acute myocardial infarction Agranulocytosis Allergic dermatitis Anaphylaxis Anemia Angina Angioedema Aplastic anemia Black tarry stools Bloody stools Bloody vomit Blurred vision Bronchospastic pulmonary disease Bullous dermatitis Cardiac arrhythmia Cerebrovascular accident Chest pain Chest tightness Depression Diplopia DRESS syndrome Duodenal ulcer Dyspnea Erythema multiforme Esophageal ulcer Exfoliative dermatitis Gastric ulcer Gastroenteritis Gastrointestinal hemorrhage Gastrointestinal perforation Gastrointestinal ulcer Glossitis Granulocytopenic disorder Hepatic failure Hepatitis Hyperkalemia Hypertension Hyperuricemia Hypokalemia Interstitial nephritis Interstitial pneumonitis Jaundice Laryngeal edema Leukopenia Loffler syndrome Mood changes Nephrotoxicity Pancreatitis Pancytopenia Peptic ulcer Pseudoporphyria Stevens-johnson syndrome Syncope Thrombocytopenic disorder Thrombophlebitis Toxic epidermal necrolysis Urticaria Vasculitis Visual changes Wheezing

There are 38 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Body fluid retention Diarrhea Dyspepsia	Aphthous stomatitis Constipation Dizziness Drowsy Fatigue Flatulence Headache disorder Hyperhidrosis Insomnia Nausea Nervousness Pruritus of skin Vomiting Xerostomia

Rare/Very Rare
Acne vulgaris Acute cognitive impairment Agitation Altered mental status Anorexia Dysgeusia Dysphagia Fever General weakness Hyperglycemia Increased appetite Malaise Palpitations Paresthesia Proteinuria Skin photosensitivity Symptoms of anxiety Tremor Vertigo Weight gain

Use of NSAIAs, including nabumetone, during pregnancy at about 30 weeks' gestation or later increases the risk of premature closure of the fetal ductus arteriosus. NSAIA use at about 20 weeks' gestation or later has been associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment. Oligohydramnios or neonatal renal impairment has occurred, on average, after days to weeks of treatment.

Infrequently, oligohydramnios has been reported as soon as 48 hours after initiation. The decrease in amniotic fluid is generally transient in most, but not all, cases, and is reversible upon cessation of the drug. A limited number of case reports describe maternal NSAIA use and irreversible neonatal dysfunction without oligohydramnios.

Some cases required invasive procedures, such as exchange transfusion or dialysis. A reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAIA use is unknown due to the inherent limitations of postmarketing studies and reports. Because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIAs through maternal use is uncertain.

Observational data regarding other embryofetal risks with NSAIAs during the first or second trimester of pregnancy are inconclusive. Animal data indicate that prostaglandins have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, inhibitors of prostaglandin synthesis, such as nabumetone, resulted in increased pre- and post-implantation loss.

Prostaglandins also have an important role in fetal kidney development. In animal studies, inhibitors of prostaglandin synthesis have been reported to impair kidney development at clinically relevant doses. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential fetal risk.

If used, limit the dose and duration of nabumetone use between 20 and 30 weeks' gestation. Avoid nabumetone use at about 30 weeks' gestation and later in pregnancy. The effects of nabumetone on labor and delivery are unknown. In animal studies with NSAIAs, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred.

The distribution of nabumetone in human milk is unknown. The presence of 6-methoxy-2- naphthylacetic acid (6-MNA) has been detected in the milk of lactating rats. Due to the potential for serious adverse reactions in nursing infants from nabumetone, discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Of the 1677 patients treated with nabumetone in clinical studies, 411 patients (24%) were 65 years or older; 22 patients (1%) were 75 years or older. No overall differences in efficacy or safety were observed between older and younger patients. Similar results were observed in a 1-year, non-US postmarketing surveillance study of 10,800 patients treated with nabumetone, of whom 4577 (42%) were 65 years or older. As with any NSAIAs, exercise caution in treating patients 65 years and older.