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Drug overview for FEBUXOSTAT (febuxostat):
Generic name: FEBUXOSTAT (feb-UX-oh-stat)
Drug class: Hyperuricemia Agents (non-uricosuric)
Therapeutic class: Gout and Hyperuricemia Therapy
Febuxostat is a xanthine oxidase inhibitor.
No enhanced Uses information available for this drug.
Generic name: FEBUXOSTAT (feb-UX-oh-stat)
Drug class: Hyperuricemia Agents (non-uricosuric)
Therapeutic class: Gout and Hyperuricemia Therapy
Febuxostat is a xanthine oxidase inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
FEBUXOSTAT 40 MG TABLET
FEBUXOSTAT 80 MG TABLET
The following indications for FEBUXOSTAT (febuxostat) have been approved by the FDA:
Indications:
Prevention of acute gout attack
Professional Synonyms:
Acute gout attack prophylaxis
Prevention of acute gout flare
Indications:
Prevention of acute gout attack
Professional Synonyms:
Acute gout attack prophylaxis
Prevention of acute gout flare
The following dosing information is available for FEBUXOSTAT (febuxostat):
The recommended initial dosage of febuxostat for the management of hyperuricemia in patients with gout is 40 mg once daily. The dosage of febuxostat may be increased to 80 mg once daily in patients who do not achieve serum urate concentrations of less than 6 mg/dL following 2 weeks of therapy with febuxostat 40 mg once daily.
Febuxostat is administered orally without regard to meals or antacids.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FEBUXOSTAT 40 MG TABLET | Maintenance | Adults take 1 tablet (40 mg) by oral route once daily |
| FEBUXOSTAT 80 MG TABLET | Maintenance | Adults take 1 tablet (80 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FEBUXOSTAT 40 MG TABLET | Maintenance | Adults take 1 tablet (40 mg) by oral route once daily |
| FEBUXOSTAT 80 MG TABLET | Maintenance | Adults take 1 tablet (80 mg) by oral route once daily |
The following drug interaction information is available for FEBUXOSTAT (febuxostat):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Azathioprine; Mercaptopurine/Febuxostat SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Febuxostat may inhibit the metabolism of azathioprine and mercaptopurine by xanthine oxidase.(1) CLINICAL EFFECTS: Concurrent use of febuxostat may result in elevated levels of and toxicity from azathioprine and mercaptopurine.(1) PREDISPOSING FACTORS: Higher doses of the thiopurine would increase the risk for severe toxicity. Patients with reduced or absent thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) activity are at higher risk of accumulating thiopurine metabolites and severe myelosuppression, since two thiopurine metabolism pathways would be blocked. Approximately 0.3 % of patients of European, Latino, or African descent have mutations of the TPMT gene resulting in little to no TPMT activity (homozygous deficiency), and approximately 10 % have intermediate TPMT activity (heterozygous deficiency). NUDT15 deficiency is not seen in patients of African descent and is seen in less than 1 % of patients of European descent. Approximately 1 % of patients of East Asian descent, 0.5 % of patients of central/south Asian descent, and 2 % of patients of Latino descent have homozygous NUDT15 deficiency. About 17 % of patients of East Asian descent, 13 % of patients of central/south Asian descent, and 8 % of patients of Latino descent have heterozygous NUDT15 deficiency.(2) PATIENT MANAGEMENT: The US manufacturer of febuxostat states that the concurrent use of azathioprine or mercaptopurine is contraindicated.(1) DISCUSSION: Azathioprine and mercaptopurine are metabolized by xanthine oxidase. Although no formal interaction studies with febuxostat have been performed, allopurinol, another xanthine oxidase inhibitor, has been shown to increase azathioprine and mercaptopurine levels. Febuxostat is expected to also increase levels of these agents, which could result in severe toxicity.(1) A review found 19 case reports of myelosuppressive adverse events with the combination of febuxostat and thiopurines including anemia, leukopenia, pancytopenia, and decreased red blood cells. Sixteen of the 19 cases resulted in hospitalization, and 17 of the 19 cases required one or more additional treatments including blood products, granulocyte or erythropoietin stimulating agents, antimicrobials, and immune globulin.(3) One or more of the drug pairs linked to this monograph have been included in a list of interactions that should be considered "high-priority" for inclusion and should not be inactivated in EHR systems. This DDI subset was vetted by an expert panel commissioned by the U.S. Office of the National Coordinator (ONC) for Health Information Technology. |
AZASAN, AZATHIOPRINE, AZATHIOPRINE SODIUM, IMURAN, MERCAPTOPURINE, PURIXAN |
| Rosuvastatin (Greater Than 20 mg)/Febuxostat SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Rosuvastatin is a substrate of the BCRP transporter.(1,2) Febuxostat has been shown to inhibit this transporter and may increase intestinal absorption and decrease hepatic uptake of rosuvastatin.(1-2) CLINICAL EFFECTS: Concurrent use of febuxostat may result in increased levels and side effects from rosuvastatin, including rhabdomyolysis.(1,2) PREDISPOSING FACTORS: The risk for myopathy or rhabdomyolysis may be greater in patients 65 years and older, inadequately treated hypothyroidism, renal impairment, carnitine deficiency, malignant hyperthermia, or in patients with a history of myopathy or rhabdomyolysis. Patients with a SLCO1B1 polymorphism that leads to decreased function of the hepatic uptake transporter OATP1B1 may have increased statin concentrations and be predisposed to myopathy or rhabdomyolysis. Patients on rosuvastatin with ABCG2 polymorphisms leading to decreased or poor BCRP transporter function may have increased rosuvastatin concentrations and risk of myopathy. PATIENT MANAGEMENT: The US manufacturer of rosuvastatin states that the dose of rosuvastatin should not exceed 20 mg daily when used concurrently with febuxostat.(1) Monitor patients closely for signs and symptoms of toxicity from increased rosuvastatin concentrations.(1) DISCUSSION: In a study, febuxostat 120 mg daily for 4 days increased the area-under-curve (AUC) and maximum concentration (Cmax) of single-dose rosuvastatin 10 mg by 1.9-fold and 2.1-fold, respectively.(1) |
CRESTOR, EZALLOR SPRINKLE, ROSUVASTATIN CALCIUM, ROSUVASTATIN-EZETIMIBE, ROSZET |
There are 5 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Pazopanib/Selected Inhibitors of P-gp or BCRP SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of P-glycoprotein (P-gp) or BCRP may increase the absorption of pazopanib.(1) CLINICAL EFFECTS: The concurrent administration of pazopanib with an inhibitor of P-glycoprotein or BCRP may result in elevated levels of pazopanib and signs of toxicity.(1) PREDISPOSING FACTORS: The risk of QT prolongation or torsade de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsade de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age.(2) Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsade de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, and/or renal/hepatic dysfunction).(2) PATIENT MANAGEMENT: The US manufacturer of pazopanib states concurrent use of P-gp inhibitors or BCRP inhibitors should be avoided.(1) Monitor patients for increased side effects from pazopanib. If concurrent therapy is warranted, consider obtaining serum calcium, magnesium, and potassium levels and monitoring ECG at baseline and at regular intervals. Correct any electrolyte abnormalities. Instruct patients to report any irregular heartbeat, dizziness, or fainting. DISCUSSION: Pazopanib is a substrate of P-gp and BCRP. Inhibitors of these transporters are expected to increase pazopanib levels.(1) BCRP inhibitors linked to this monograph include: asciminib, belumosudil, clopidogrel, cyclosporine, curcumin, darolutamide, eltrombopag, enasidenib, febuxostat, fostemsavir, grazoprevir, lazertinib, leflunomide, leniolisib, momelotinib, oteseconazole, pantoprazole, pirtobrutinib, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, tafamidis, teriflunomide, tolvaptan, turmeric, and vadadustat.(1,3-5) P-glycoprotein inhibitors linked to this monograph include: asunaprevir, belumosudil, capmatinib, carvedilol, cyclosporine, danicopan, daridorexant, diltiazem, flibanserin, fostamatinib, ginseng, glecaprevir/pibrentasvir, isavuconazonium, ivacaftor, ledipasvir, neratinib, sofosbuvir/velpatasvir/voxilaprevir, tepotinib, tezacaftor, ticagrelor, valbenazine, verapamil, vimseltinib, and voclosporin.(3,4) |
PAZOPANIB HCL, VOTRIENT |
| Cladribine/Selected Inhibitors of BCRP SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of BCRP may increase the absorption of cladribine.(1-2) CLINICAL EFFECTS: The concurrent administration of cladribine with an inhibitor of BCRP may result in elevated levels of cladribine and signs of toxicity.(1-2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of cladribine states concurrent use of BCRP inhibitors should be avoided during the 4- to 5-day cladribine treatment.(1-2) Selection of an alternative concurrent medication with no or minimal transporter inhibiting proprieties should be considered. If this is not possible, dose reduction to the minimum mandatory dose of the BCRP inhibitor, separation in timing of administration, and careful patient monitoring is recommended.(1-2) Monitor for signs of hematologic toxicity. Lymphocyte counts should be monitored. DISCUSSION: Cladribine is a substrate of BCRP. Inhibitors of this transporter are expected to increase cladribine levels.(1-2) BCRP inhibitors linked to this monograph include: capmatinib, clopidogrel, curcumin, danicopan, darolutamide, dasabuvir, eltrombopag, enasidenib, febuxostat, fostamatinib, fostemsavir, glecaprevir/pibrentasvir, grazoprevir, lazertinib, oteseconazole, pacritinib, pantoprazole, paritaprevir, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, selpercatinib, sofosbuvir/velpatasvir/voxilaprevir, tafamidis, ticagrelor, tolvaptan, turmeric, and vadadustat.(1-4) |
CLADRIBINE, MAVENCLAD |
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
| Atorvastatin/Selected BCRP Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: BCRP inhibitors may result in increased absorption of atorvastatin.(1) CLINICAL EFFECTS: Administration of atorvastatin with BCRP inhibitors may result in elevated levels of atorvastatin, which could result in rhabdomyolysis.(1) PREDISPOSING FACTORS: The risk for myopathy or rhabdomyolysis may be greater in patients 65 years and older, inadequately treated hypothyroidism, renal impairment, carnitine deficiency, malignant hyperthermia, or in patients with a history of myopathy or rhabdomyolysis. Patients with a SLCO1B1 polymorphism that leads to decreased function of the hepatic uptake transporter OATP1B1 may have increased statin concentrations and be predisposed to myopathy or rhabdomyolysis. PATIENT MANAGEMENT: Atorvastatin is a substrate of the efflux transporter BCRP.(1) The US manufacturers of darolutamide and leniolisib recommend avoiding concurrent use with BCRP substrates such as atorvastatin.(2,3) If concurrent therapy is deemed medically necessary, monitor patients for signs and symptoms of myopathy/rhabdomyolysis, including muscle pain/tenderness/weakness, fever, unusual tiredness, changes in the amount of urine, and/or discolored urine.(2) DISCUSSION: Concurrent administration of darolutamide with rosuvastatin increased the mean area-under-the-curve (AUC) and maximum concentration (Cmax) of rosuvastatin approximately 5-fold.(2) The study authors found that darolutamide has no effect on total or renal clearance of rosuvastatin and thus no likely effect on OATP or OAT3, which suggests the increase in rosuvastatin plasma concentrations is due to BCRP inhibition.(4) Concurrent administration of leniolisib with rosuvastatin increased the systemic exposure of rosuvastatin by 2-fold.(3) BCRP inhibitors linked to this monograph include: capmatinib, danicopan, darolutamide, febuxostat, fostamatinib, leflunomide, leniolisib, momelotinib, oteseconazole, pacritinib, pirtobrutinib, regorafenib, selpercatinib, sofosbuvir/velpatasvir/voxilaprevir, tafamidis, teriflunomide, ticagrelor, vadadustat, and velpatasvir.(5,6) |
AMLODIPINE-ATORVASTATIN, ATORVALIQ, ATORVASTATIN CALCIUM, CADUET, LIPITOR |
| Topotecan/BCRP Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of the BCRP transporter may increase the intestinal absorption and hepatic uptake of topotecan.(1) CLINICAL EFFECTS: The concurrent administration of topotecan with an inhibitor of BCRP may result in elevated levels of topotecan and signs of toxicity. These signs may include but are not limited to anemia, diarrhea, and thrombocytopenia.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of topotecan states that the use of topotecan and BCRP inhibitors should be avoided. If concurrent use is warranted, carefully monitor patients for adverse effects.(1) DISCUSSION: In clinical studies, the combined use of elacridar (100 mg to 1000 mg), a BCRP and P-gp inhibitor, increased the area-under-curve (AUC) of topotecan approximately 2.5-fold.(1) BCRP inhibitors linked to this monograph include: capmatinib, clopidogrel, curcumin, danicopan, dasabuvir, elbasvir, enasidenib, febuxostat, fostamatinib, fostemsavir, glecaprevir, grazoprevir, lazertinib, oteseconazole, pacritinib, pantoprazole, paritaprevir, pibrentasvir, pirtobrutinib, regorafenib, resmetirom, ritonavir, roxadustat, tafamidis, ticagrelor, tolvaptan, turmeric, vadadustat, velpatasvir, and voxilaprevir.(2,3) |
HYCAMTIN, TOPOTECAN HCL |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Theophylline/Febuxostat SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Febuxostat may inhibit the metabolism of theophylline by xanthine oxidase.(1) CLINICAL EFFECTS: Concurrent use of febuxostat may result in elevated levels of and toxicity from theophylline.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of febuxostat states that the concurrent use of theophylline should be approached with caution.(1) DISCUSSION: Concurrent febuxostat (80 mg daily) increased the maximum concentration (Cmax) and area-under-curve (AUC) of theophylline by 6% and 6.5%, respectively. The amount of 1-methylxanthine, a major theophylline metabolite, excreted in the urine increased 400-fold. The safety of long-term exposure to 1-methylxanthine has not been determined.(1) |
AMINOPHYLLINE, ELIXOPHYLLIN, THEO-24, THEOPHYLLINE, THEOPHYLLINE ANHYDROUS, THEOPHYLLINE ER, THEOPHYLLINE ETHYLENEDIAMINE |
| Ubrogepant/P-gp or BCRP Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Inhibitors of P-glycoprotein (P-gp) or BCRP may increase the absorption of ubrogepant.(1) CLINICAL EFFECTS: The concurrent administration of ubrogepant with an inhibitor of P-glycoprotein or BCRP may result in elevated levels of ubrogepant.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer recommends a dosage adjustment of ubrogepant when coadministered with P-gp or BCRP inhibitors. The dose of ubrogepant should not exceed 50 mg for initial dose. If a second dose of ubrogepant is needed, the dose should not exceed 50 mg.(1) The manufacturer of vimseltinib states concurrent use with P-gp substrates should be avoided. If concurrent use cannot be avoided, take vimseltinib at least 4 hours prior to ubrogepant.(3) DISCUSSION: Ubrogepant is a substrate of P-gp and BCRP transporters. Use of P-gp or BCRP inhibitors may increase the exposure of ubrogepant. Clinical drug interaction studies with inhibitors of these transporters were not conducted. The US manufacturer of ubrogepant recommends dose adjustment if ubrogepant is coadministered with P-gp or BCRP inhibitors.(1) BCRP inhibitors linked to this monograph include: belumosudil, clopidogrel, curcumin, eltrombopag, febuxostat, fostemsavir, leniolisib, momelotinib, oteseconazole, pantoprazole, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, tafamidis, oral tedizolid, turmeric, and vadadustat.(2-5) P-glycoprotein inhibitors linked to this monograph include: asunaprevir, belumosudil, carvedilol, danicopan, daridorexant, neratinib, osimertinib, propafenone, quinidine, sofosbuvir/velpatasvir/voxilaprevir, tepotinib, tezacaftor, valbenazine, vimseltinib, and voclosporin.(2-5) |
UBRELVY |
| Rosuvastatin (Less Than or Equal To 20 mg)/Febuxostat SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Rosuvastatin is a substrate of the BCRP transporter.(1,2) Febuxostat has been shown to inhibit this transporter and may increase intestinal absorption and decrease hepatic uptake of rosuvastatin.(1-2) CLINICAL EFFECTS: Concurrent use of febuxostat may result in increased levels and side effects from rosuvastatin, including rhabdomyolysis.(1,2) PREDISPOSING FACTORS: The risk for myopathy or rhabdomyolysis may be greater in patients 65 years and older, inadequately treated hypothyroidism, renal impairment, carnitine deficiency, malignant hyperthermia, or in patients with a history of myopathy or rhabdomyolysis. Patients with a SLCO1B1 polymorphism that leads to decreased function of the hepatic uptake transporter OATP1B1 may have increased statin concentrations and be predisposed to myopathy or rhabdomyolysis. Patients on rosuvastatin with ABCG2 polymorphisms leading to decreased or poor BCRP transporter function may have increased rosuvastatin concentrations and risk of myopathy. PATIENT MANAGEMENT: The US manufacturer of rosuvastatin states that the dose of rosuvastatin should not exceed 20 mg daily when used concurrently with febuxostat.(1) Monitor patients closely for signs and symptoms of toxicity from increased rosuvastatin concentrations.(1) DISCUSSION: In a study, febuxostat 120 mg daily for 4 days increased the area-under-curve (AUC) and maximum concentration (Cmax) of single-dose rosuvastatin 10 mg by 1.9-fold and 2.1-fold, respectively.(1) |
CRESTOR, EZALLOR SPRINKLE, ROSUVASTATIN CALCIUM, ROSUVASTATIN-EZETIMIBE, ROSZET |
The following contraindication information is available for FEBUXOSTAT (febuxostat):
Drug contraindication overview.
Concomitant therapy with azathioprine or mercaptopurine. (See Drug Interactions: Drugs Metabolized by Xanthine Oxidase.)
Concomitant therapy with azathioprine or mercaptopurine. (See Drug Interactions: Drugs Metabolized by Xanthine Oxidase.)
There are 0 contraindications.
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Atherosclerotic cardiovascular disease |
| Cerebrovascular disorder |
| Chronic heart failure |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
There are 1 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 |
The following adverse reaction information is available for FEBUXOSTAT (febuxostat):
Adverse reaction overview.
Adverse effects reported in 1% or more of patients receiving febuxostat include liver function abnormalities, nausea, arthralgia, and rash.
Adverse effects reported in 1% or more of patients receiving febuxostat include liver function abnormalities, nausea, arthralgia, and rash.
There are 61 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Skin rash |
Acute gouty arthritis Increased alanine transaminase Increased aspartate transaminase |
| Rare/Very Rare |
|---|
|
Abnormal ECG Acute myocardial infarction Agranulocytosis Anaphylaxis Anemia Angina Angioedema Atrial fibrillation Atrial flutter Biliary calculus Bloody vomit Bone marrow depression Bradycardia Cardiac arrhythmia Cataracts Cerebrovascular accident Chronic heart failure Colitis DRESS syndrome Drug-induced psychosis Eosinophilia Epistaxis Gastroenteritis Guillain-barre syndrome Hearing loss Hematuria Hepatic failure Hepatitis Hepatomegaly Hyperbilirubinemia Hypersensitivity drug reaction Hypertension Hypokalemia Hypotension Idiopathic thrombocytopenic purpura Interstitial nephritis Jaundice Kidney stone Leukocytosis Myelodysplastic syndrome Neutropenic disorder Pancreatitis Pancytopenia Paresthesia Purpura Rectal bleeding Renal failure Rhabdomyolysis Splenomegaly Stevens-johnson syndrome Tachycardia Thrombocytopenic disorder Thromboembolic disorder Toxic epidermal necrolysis Urticaria Worsening of chronic heart failure |
There are 51 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Arthralgia Nausea |
Acute abdominal pain Diarrhea Dizziness Headache disorder |
| Rare/Very Rare |
|---|
|
Abdominal distension Abnormal desquamation Aggressive behavior Allergic dermatitis Alopecia Appetite changes Blurred vision Body odor Chest pain Constipation Dehydration Dyschromia Dyspepsia Edema Erectile dysfunction Erythema Fatigue Flatulence Flu-like symptoms Flushing Gait abnormality Gastritis Gastroesophageal reflux disease General weakness Gingival pain Gynecomastia Hair discoloration Hypertriglyceridemia Libido changes Mastalgia Mood changes Myalgia Palpitations Peptic ulcer Petechiae Proteinuria Pruritus of skin Skin photosensitivity Stomatitis Tinnitus Tremor Urinary urge incontinence Vertigo Vomiting Xerostomia |
The following precautions are available for FEBUXOSTAT (febuxostat):
Safety and efficacy have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data are inadequate regarding use of febuxostat in pregnant women. Animal reproduction studies using febuxostat have not revealed evidence of fetal harm at exposures greater than those attained with the maximum recommended human dosage.
Febuxostat is distributed into milk in rats at concentrations up to approximately 7 times plasma concentrations of the drug. It is not known whether febuxostat distributes into human milk, affects the breast-fed infant, or affects milk production. The benefits of breast-feeding and the importance of febuxostat to the woman should be considered along with the potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
No substantial differences in safety and efficacy have been observed in geriatric patients relative to younger adults, but increased sensitivity of some older patients cannot be ruled out. Pharmacokinetic values in geriatric adults were similar to those in younger adults. Dosage adjustment based on age is not needed.
The following prioritized warning is available for FEBUXOSTAT (febuxostat):
WARNING: Febuxostat may rarely cause very serious side effects including heart attack, stroke, or possibly fatal heart-related problems. Before taking this medication, tell your doctor if you have heart disease, chest pain (angina), or have had a heart attack or stroke in the past since these conditions may increase your risk. Discuss the risks and benefits of this medication and treatment options with your doctor. Get medical help right away if you have any of these very serious side effects: chest/jaw/left arm pain, unusual sweating, shortness of breath, fast/irregular heartbeat, dizziness, fainting, weakness on one side of the body, sudden vision changes, confusion, trouble speaking, sudden severe headache.
WARNING: Febuxostat may rarely cause very serious side effects including heart attack, stroke, or possibly fatal heart-related problems. Before taking this medication, tell your doctor if you have heart disease, chest pain (angina), or have had a heart attack or stroke in the past since these conditions may increase your risk. Discuss the risks and benefits of this medication and treatment options with your doctor. Get medical help right away if you have any of these very serious side effects: chest/jaw/left arm pain, unusual sweating, shortness of breath, fast/irregular heartbeat, dizziness, fainting, weakness on one side of the body, sudden vision changes, confusion, trouble speaking, sudden severe headache.
The following icd codes are available for FEBUXOSTAT (febuxostat)'s list of indications:
| Prevention of acute gout attack | |
| E79.0 | Hyperuricemia without signs of inflammatory arthritis and tophaceous disease |
| M10 | Gout |
| M10.00 | Idiopathic gout, unspecified site |
| M10.30 | Gout due to renal impairment, unspecified site |
| M10.40 | Other secondary gout, unspecified site |
| M10.9 | Gout, unspecified |
| M1A.00x1 | Idiopathic chronic gout, unspecified site, with tophus (tophi) |
| M1A.20x1 | Drug-induced chronic gout, unspecified site, with tophus (tophi) |
| M1A.30x1 | Chronic gout due to renal impairment, unspecified site, with tophus (tophi) |
| M1A.40x1 | Other secondary chronic gout, unspecified site, with tophus (tophi) |
| M1A.9xx0 | Chronic gout, unspecified, without tophus (tophi) |
| M1A.9xx1 | Chronic gout, unspecified, with tophus (tophi) |
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