Safety

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Zileuton Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

· 5 min read

Zileuton Tablet: Uses, Dosage, Side Effects, Precautions and Alternates
Generic nameZileuton
Drug classLeukotriene synthesis inhibitor
FormsTablet, Extended-release tablet
Zileuton Tablet: Uses, Dosage, Side Effects, Precautions and Alternates product

Quick overview

Zileuton Tablet (generic name: Zileuton) is a prescription medicine belonging to the leukotriene synthesis inhibitor drug class. It is used for the long-term prevention and control of asthma symptoms in adults and children 12 years and older. It is not a rescue medicine and does not stop an asthma attack that has already started.

What is Zileuton Tablet

Zileuton is a prescription medicine used to prevent and control asthma symptoms over the long term. It is not a rescue medicine and does not stop an asthma attack that has already started.

Zileuton Tablet uses

  • Prevents wheezing, shortness of breath, coughing, and chest tightness caused by asthma
  • Used for long-term control of asthma in adults and children 12 years and older
  • Used for the long-term management of asthma
  • Helps prevent asthma symptoms such as wheezing and shortness of breath
  • Helps control inflammation in the airways

Benefits of Zileuton Tablet

  • Helps control asthma symptoms over time, though it does not cure asthma
  • Helps reduce asthma symptoms
  • May decrease the frequency of asthma flare-ups
  • Helps improve breathing by reducing leukotriene-related airway inflammation
  • Supports long-term asthma control when taken as prescribed

How Zileuton Tablet works

Zileuton blocks the body from making substances called leukotrienes, which cause swelling, tightening, and extra mucus in the airways. By stopping their formation, the medicine helps keep airways more open.

Zileuton Tablet dosage

The regular tablet is usually taken four times a day with or without food. The extended-release tablet is usually taken twice a day, within one hour after the morning and evening meals. Swallow extended-release tablets whole; do not split, chew, or crush them. Do not use this medicine to treat a sudden asthma attack; use the short-acting inhaler your doctor prescribed for that. Keep taking your other asthma medicines as directed unless your doctor tells you to stop or change them.

It may take several days or longer to feel the full benefit, so continue taking it even if you feel well. If you miss a dose, take it as soon as you remember, but if it is almost time for the next dose, skip the missed one and do not double up. Extended-release tablets work best when taken with food.

Age groupDose
Under 12 yearsNot recommended; safety and efficacy not established
12–17 years600 mg, 4 times daily, as prescribed
18–64 years600 mg, 4 times daily (immediate-release)
65+ years600 mg, 4 times daily; doctor-directed

Available forms and strengths

  • Tablet
  • Extended-release tablet

Side effects of Zileuton Tablet

Common

  • Headache
  • Heartburn
  • Diarrhea
  • Muscle pain
  • Nose and throat irritation
  • Pain or fullness in the face
  • Sinusitis
  • Nausea
  • Throat pain
  • Upper respiratory infection

Serious

  • Rash
  • Hives
  • Pain in the upper right part of the stomach
  • Nausea and vomiting
  • Excessive tiredness
  • Itching
  • Yellowing of the skin or eyes
  • Dark urine
  • Flu-like symptoms
  • Liver problems with increased liver enzymes, which can lead to severe liver injury
  • Sleep disorders and changes in behavior, including agitation, aggressive behavior, anxiety, irritability, unusual dreams, hallucinations, depression, difficulty sleeping, restlessness, suicidal thoughts, or tremor

Warnings and precautions

  • This medicine can cause liver enzyme increases and, in rare cases, severe liver injury. Regular blood tests are needed to monitor your liver while on treatment.
  • This medicine can cause changes in sleep and behavior, such as agitation, aggressive behavior, anxiety, irritability, unusual dreams, hallucinations, depression, trouble sleeping, restlessness, suicidal thoughts, or tremor. Tell your doctor right away if these occur.
  • Do not use this medicine to treat a sudden asthma attack; it is not a quick-relief medicine. Use your prescribed fast-acting inhaler for sudden symptoms.
  • Do not stop taking this medicine or change your dose without talking to your doctor, even if you feel well or have no asthma symptoms.
  • This medicine should not be given to anyone else, even if they have similar symptoms, as it may harm them.
  • Tell your doctor if you are pregnant or planning to become pregnant. It is not known if this medicine could harm an unborn baby, so it should only be used if the benefits outweigh the risks.
  • It is not known if this medicine passes into breast milk. You and your doctor should decide whether you will take this medicine or breastfeed, not both.
  • No dose changes are needed for people with kidney problems or those on dialysis.
  • This medicine should not be used by people with active liver disease, and your doctor will likely avoid prescribing it if you have liver disease. Tell your doctor about any past liver problems, including hepatitis, jaundice, or dark urine. Liver enzyme blood tests are needed before and regularly during treatment.
  • Ask your doctor about safe alcohol use while taking this medicine, and tell your doctor if you drink or have ever drunk large amounts of alcohol, since this may increase the risk of liver problems.

Storage

  • Keep this medication in the container it came in, tightly closed, and out of reach of children
  • Store it at room temperature and away from excess heat and moisture (not in the bathroom)
  • Store between 68°F and 77°F (20°C to 25°C)
  • Protect from light and replace the cap each time after use
  • Dispose of unneeded medications in a way so that pets, children, and other people cannot take them; do not flush this medication down the toilet; use a medicine take-back program if available

When to see a doctor

  • Call your doctor right away if you have pain in the upper right part of your stomach, nausea, tiredness, lack of energy, itching, yellowing of your skin or eyes, dark urine, or flu-like symptoms, as these may be signs of liver problems.
  • Call your doctor right away if you notice new agitation, aggressive behavior, anxiety, irritability, unusual dreams, hallucinations, depression, trouble sleeping, restlessness, suicidal thoughts, or shaking.
  • Get medical help right away if you need your rescue inhaler more often than usual or you reach the maximum number of puffs allowed in 24 hours, as this may mean your asthma is getting worse.
  • Tell your doctor right away if you develop a rash or hives, which could be signs of an allergic reaction.
  • If you take too much of this medicine, call your doctor or a poison control center right away.

Alternatives

  • Montelukast
  • Budesonide
  • Theophylline

Watch the video

Video: Zileuton Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

FAQs

What is Zileuton Tablet used for?

Zileuton is used for the long-term prevention and control of asthma symptoms such as wheezing, shortness of breath, coughing, and chest tightness in adults and children 12 years and older. It is not a rescue medicine and does not stop an asthma attack that has already started.

How does Zileuton Tablet work?

Zileuton blocks the body from making substances called leukotrienes, which cause swelling, tightening, and extra mucus in the airways. By stopping their formation, the medicine helps keep airways more open.

How is Zileuton Tablet taken?

The regular tablet is usually taken four times a day with or without food. The extended-release tablet is usually taken twice a day, within one hour after the morning and evening meals, and should be swallowed whole without splitting, chewing, or crushing.

What are the serious side effects of Zileuton Tablet?

Serious side effects include liver problems with increased liver enzymes that can lead to severe liver injury, signs of which include upper right stomach pain, nausea, vomiting, tiredness, yellowing of skin or eyes, and dark urine. It can also cause changes in sleep and behavior, including agitation, hallucinations, depression, and suicidal thoughts.

Can Zileuton Tablet be used during a sudden asthma attack?

No, Zileuton should not be used to treat a sudden asthma attack since it is not a quick-relief medicine. A prescribed fast-acting inhaler should be used for sudden symptoms.

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Sources

  1. https://medlineplus.gov/druginfo/meds/a697013.html
  2. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc29c998-1324-46aa-8386-e5b2fc9e0b16
  3. https://www.practo.com/medicine-info/zileuton-719-api