Febuxostat (Oral route)
Xanthine Oxidase Inhibitor
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of febuxostat in the elderly.
|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.|
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.
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.
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.
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 of This Medicine:
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.
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.
- For treatment of hyperuricemia:
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.
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 While Using This Medicine:
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 of This Medicine:
- Abdominal or stomach fullness or pain
- arm, back, or jaw pain
- black, tarry stools
- bloody nose
- blurred vision
- chest pain or discomfort
- cloudy urine
- dark urine
- decreased frequency or amount of urine
- difficult or labored breathing
- difficulty with moving
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of fullness
- gaseous abdominal or stomach pain
- general tiredness and weakness
- heavier menstrual periods
- inability to speak
- increase in heart rate
- increased thirst
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of bladder control
- muscle aching or cramping
- nausea and vomiting
- pain, swelling, or redness in the joints
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- rapid breathing
- redness of the skin
- right upper abdominal or stomach pain and fullness
- runny nose
- severe or sudden headache
- shortness of breath
- slow or fast heartbeat
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sunken eyes
- temporary blindness
- tightness in the chest
- trouble sleeping
- troubled breathing or swallowing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weakness in the arm or leg on one side of the body, sudden and severe
- weight gain
- wrinkled skin
- yellow eyes and skin
- Incidence not known
- Blistering, peeling, or loosening of the skin
- difficulty with swallowing
- muscle cramps or spasms
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- Acid or sour stomach
- bad, unusual, or unpleasant (after) taste
- blistering, crusting, irritation, itching, or reddening of the skin
- body aches or pain
- breast pain
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- changes in hair color
- continuing ringing or buzzing or other unexplained noise in the ears
- cough producing mucus
- cracked, dry, or scaly skin
- decrease in smell
- decreased interest in sexual intercourse
- ear congestion
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- fruit-like breath odor
- gum pain
- hair loss or thinning of the hair
- hearing loss
- inability to have or keep an erection
- inability to move the arms and legs
- increased or decreased appetite
- increased sensitivity of the skin to sunlight
- increased sweating
- increased urination
- large, flat, blue, or purplish patches in the skin
- loss in sexual ability, desire, drive, or performance
- loss of appetite
- loss of consciousness
- loss of voice
- muscle or bone pain or stiffness
- muscle spasm, tightness, or weakness
- muscle twitching
- nasal congestion
- painful blisters on the trunk of the body
- pains in the stomach, side, or abdomen, possibly radiating to the back
- sensation of spinning
- severe or continuing stomach pain
- severe sunburn
- shakiness in the legs, arms, hands, or feet
- skin rash, encrusted, scaly, and oozing
- sleepiness or unusual drowsiness
- small red or purple spots on the skin
- stomach discomfort, upset, or pain
- sudden numbness and weakness in the arms and legs
- swelling of the breasts or breast soreness in both females and males
- throat irritation
- trembling or shaking of the hands or feet
- trouble sleeping
- unexplained weight loss
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- weight loss
- Incidence not known
- Aggressive thoughts
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:
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:
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.
Last Updated: 11/4/2014