Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Uloric

Descriptions


Febuxostat is used to treat hyperuricemia (high uric acid in the blood) in patients with gout. This medicine is a xanthine oxidase inhibitor. It works by causing less uric acid to be produced by the body.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of febuxostat in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of febuxostat in the elderly.

Pregnancy

Information about this febuxostat-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Azathioprine
  • Mercaptopurine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Theophylline

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Heart attack, history of or
  • Stroke, history of—Use with caution. There may be an increased risk of these conditions occurring again.
  • Kidney disease, severe or
  • Liver disease, severe—Use with caution. This medicine has not be studied in patients with these conditions.
  • Secondary hyperuricemia (Lesch-Nyhan syndrome (rare, inherited enzyme problem), malignant disease (cancer), or organ transplant recipients)—Use is not recommended in patients with these conditions.

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food. It may also be taken with antacids.

At first, when you start using this medicine you may have more gout attacks. Keep using this medicine even if this happens. Your doctor may give you other medicines (such as colchicine or pain medicines [NSAIDs]) to help prevent these gout attacks.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of hyperuricemia:
      • Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 80 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use azathioprine (Azasan®, Imuran®) or mercaptopurine (Purinethol®) while you are taking this medicine. Using these medicines together can cause serious medical problems.

This medicine may increase your risk of having serious heart and blood vessel problems such as heart attack or stroke. Check with your doctor right away if start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

  1. Abdominal or stomach fullness or pain
  2. arm, back, or jaw pain
  3. black, tarry stools
  4. bloody nose
  5. blurred vision
  6. chest pain or discomfort
  7. chills
  8. cloudy urine
  9. confusion
  10. cough
  11. dark urine
  12. decreased frequency or amount of urine
  13. diarrhea
  14. difficult or labored breathing
  15. difficulty with moving
  16. dizziness
  17. dry mouth
  18. fainting
  19. fast, irregular, pounding, or racing heartbeat or pulse
  20. feeling of fullness
  21. fever
  22. gaseous abdominal or stomach pain
  23. general tiredness and weakness
  24. headache
  25. heavier menstrual periods
  26. inability to speak
  27. increase in heart rate
  28. increased thirst
  29. itching
  30. joint pain, stiffness, or swelling
  31. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  32. lightheadedness
  33. loss of appetite
  34. loss of bladder control
  35. muscle aching or cramping
  36. nausea and vomiting
  37. nervousness
  38. pain, swelling, or redness in the joints
  39. painful or difficult urination
  40. pale skin
  41. pinpoint red spots on the skin
  42. pounding in the ears
  43. rapid breathing
  44. rash
  45. redness of the skin
  46. right upper abdominal or stomach pain and fullness
  47. runny nose
  48. seizures
  49. severe or sudden headache
  50. shivering
  51. shortness of breath
  52. slow or fast heartbeat
  53. slurred speech
  54. sore throat
  55. sores, ulcers, or white spots on the lips or in the mouth
  56. sunken eyes
  57. sweating
  58. swelling
  59. temporary blindness
  60. thirst
  61. tightness in the chest
  62. trouble sleeping
  63. troubled breathing or swallowing
  64. unusual bleeding or bruising
  65. unusual tiredness or weakness
  66. vomiting of blood or material that looks like coffee grounds
  67. weakness in the arm or leg on one side of the body, sudden and severe
  68. weight gain
  69. wheezing
  70. wrinkled skin
  71. yellow eyes and skin

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. diarrhea
  3. difficulty with swallowing
  4. hives
  5. muscle cramps or spasms
  6. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  7. red skin lesions, often with a purple center
  8. red, irritated eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

  1. Acid or sour stomach
  2. anxiety
  3. bad, unusual, or unpleasant (after) taste
  4. blistering, crusting, irritation, itching, or reddening of the skin
  5. body aches or pain
  6. breast pain
  7. bruising
  8. burning feeling in the chest or stomach
  9. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  10. change in taste
  11. changes in hair color
  12. constipation
  13. continuing ringing or buzzing or other unexplained noise in the ears
  14. cough producing mucus
  15. cracked, dry, or scaly skin
  16. decrease in smell
  17. decreased interest in sexual intercourse
  18. depression
  19. ear congestion
  20. excess air or gas in the stomach or intestines
  21. feeling of constant movement of self or surroundings
  22. fruit-like breath odor
  23. gum pain
  24. hair loss or thinning of the hair
  25. hearing loss
  26. heartburn
  27. hyperventilation
  28. inability to have or keep an erection
  29. inability to move the arms and legs
  30. increased or decreased appetite
  31. increased sensitivity of the skin to sunlight
  32. increased sweating
  33. increased urination
  34. irritability
  35. large, flat, blue, or purplish patches in the skin
  36. loss in sexual ability, desire, drive, or performance
  37. loss of appetite
  38. loss of consciousness
  39. loss of voice
  40. muscle or bone pain or stiffness
  41. muscle spasm, tightness, or weakness
  42. muscle twitching
  43. nasal congestion
  44. painful blisters on the trunk of the body
  45. pains in the stomach, side, or abdomen, possibly radiating to the back
  46. sensation of spinning
  47. severe or continuing stomach pain
  48. severe sunburn
  49. shakiness in the legs, arms, hands, or feet
  50. skin rash, encrusted, scaly, and oozing
  51. sleepiness or unusual drowsiness
  52. small red or purple spots on the skin
  53. sneezing
  54. stomach discomfort, upset, or pain
  55. sudden numbness and weakness in the arms and legs
  56. sweating
  57. swelling of the breasts or breast soreness in both females and males
  58. throat irritation
  59. trembling or shaking of the hands or feet
  60. trouble sleeping
  61. unexplained weight loss
  62. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  63. weight loss

Incidence not known

  1. Aggressive thoughts
  2. delusions
  3. hallucinations

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.