Who should not use Flovent?

Flovent HFA Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Flovent HFA?

Flovent HFA (fluticasone propionate) is a steroid used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

What Are Side Effects of Flovent HFA?

Common side effects of Flovent HFA include:

• hoarseness,
• throat irritation,
• headache,
• dryness in your mouth/nose/throat,
• white patches or sores inside your mouth or on your lips,
• stuffy nose,
• sinus pain,
• cough, or
• deepened voice.

Tell your doctor if you have serious side effects of Flovent HFA including:

• signs of infection (such as fever, chills, persistent sore throat),
• vision problems,
• increased thirst or urination,
• easy bruising or bleeding,
• mental/mood changes (such as depression, mood swings, agitation), or
• bone pain.

Dosage for Flovent HFA

Flovent HFA should be orally inhaled only in patients aged 4 years and older. For adults and children 12 years of age and older, the recommended starting dose ranges from 88-440 mcg twice daily, and the highest recommended dose is 880 mcg. The pediatric dose is 88 mcg twice daily.

What Drugs, Substances, or Supplements Interact with Flovent HFA?

Flovent HFA may interact with conivaptan, diclofenac, imatinib, isoniazid, antibiotics, antifungal medications, antidepressants, heart or blood pressure medication, or HIV/AIDS medicine. Tell your doctor all medications you are taking.

Flovent HFA During Pregnancy and Breastfeeding

During pregnancy, Flovent HFA should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Flovent HFA (fluticasone propionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Flovent (fluticasone propionate) is an inhaled corticosteroid used regularly by people with asthma to maintain long-term control of symptoms and prevent asthma attacks. As with other types of corticosteroid drugs, Flovent works by suppressing the immune response, which in turn reduces the inflammation that causes airways to be hyper-responsive.

The two forms of Flovent approved by the Food and Drug Administration (FDA)—Flovent HFA (aerosolized fluticasone) and Flovent Diskus (powder form)—are available by prescription only. There are no generic forms in the United States.

Other FDA-approved fluticasone inhalants used to treat asthma include ArmonAir RespiDisk, ArmonDisk Digihaler, and Arnuity Ellipta.

Referred to as a prophylactic therapy, Flovent is used on a long-term, ongoing basis to prevent asthma symptoms.

Flovent cannot be used to relieve sudden attacks and won't replace a rescue inhaler. Rather, it is prescribed as an addition to treatment when a rescue inhaler alone is ineffective in controlling asthma symptoms.

Flovent can be used on its own but is more commonly combined with a long-acting beta-agonist (LABA).

In the past, inhaled corticosteroids were tried before LABAs, but current guidance from the Global Initiative for Asthma (GINA) recommends that they be started together for better long-term control.

For Flovent to work, it must be used on a regular schedule as directed by a healthcare provider.

There are two types of Flovent that are approved by the FDA for adults and children over the age of 4:

• Flovent HFA is an aerosolized form of fluticasone delivered in a traditional metered dose inhaler. It uses an aerosol propellant to deliver the drug into the lungs.
• Flovent Diskus is a powder that does not require a propellant to get the drug into the lungs. Instead, you have to inhale the powder on your own.

While neither is inherently better than the other in controlling asthma symptoms, there are factors that may make one more appealing to you than the other.

Flovent HFA

• Requires hand-breath coordination that new users may find awkward

• Familiar function for experienced inhaler users

• Can be used with a spacer to reduce the amount of drug in your mouth

• Has to be primed before use and may clog if not used regularly

• Has a 12-month shelf life

Flovent Diskus

• Requires simple inhalation (no hand-breath coordination needed)

• Cannot be used with a spacer

• Doesn't require priming and generally won't get clogged

• Must be used within six weeks to two months, depending on the strength

• Does not need to be regularly washed

Flovent HFA and Flovent Diskus typically are prescribed when a short-acting rescue inhaler like albuterol does not effectively control asthma symptoms.

If you use a rescue inhaler more than twice a week, the American Academy of Allergy, Asthma & Immunology (AAAAI) recommends adding daily inhaled medications to provide better long-term control. These include inhaled corticosteroids like Flovent and inhaled LABAs like Serevent (salmeterol).

The decision to start Flovent is based on the frequency and severity of asthma attacks. While pulmonary function tests (PFTs) play a central role in the diagnosis of asthma, they do not factor in as much with respect to the introduction of inhaled steroids in an asthma treatment plan.

People with a known allergy to fluticasone propionate or fluticasone furoate (a similar drug) should not take Flovent.

People with a known allergy to milk should not take Flovent Diskus as it contains lactose powder that in rare cases can be contaminated with milk protein.

People with certain health conditions also should be careful when taking Flovent:

• Glaucoma
• Cataracts
• Adrenal insufficiency
• Significant bone mineral loss

Although Flovent is not contraindicated for people with these conditions, doing so over a long period of time may speed up the progression of disease. Extra care should be taken to monitor anyone who takes Flovent and has vision problems, adrenal gland dysfunction, or osteoporosis.

Care should also be taken when considering prescribing Flovent for adults over 65, as they are more likely to have these health concerns and/or take multiple medications, some of which may interact with Flovent.

Both Flovent HFA and Flovent Diskus have been found in animal studies to be potentially harmful for fetuses, but well-controlled studies in humans are not available. The benefits of the treatment may outweigh the risks for a pregnant person, but careful consideration is needed with the guidance of a doctor or healthcare provider.

Other types of inhaled corticosteroids are available if fluticasone doesn't provide adequate control or causes intolerable side effects. These include combination inhalers that use both an inhaled steroid and a LABA.

Inhaled steroids and steroid/LABA combinations licensed for use by the FDA for moderate to severe asthma include:

Flovent HFA is available in 44-microgram (mcg), 110-mcg, and 220-mcg strengths. Flovent Diskus is available in 50-mcg, 100-mcg, and 250-mcg strengths.

The recommended dosage is based on a person's age. As a rule, the lowest dose should be used when first starting and increased if needed, never exceeding the recommended daily dose.

This is particularly important for children, as Flovent's effects on the adrenal gland may impair growth, though the risk is considered low because the drug is inhaled rather than injected or taken by mouth. Nevertheless, children should be prescribed the lowest possible dose and have their growth monitored during treatment.

It takes around one to two weeks from the start of Flovent treatment to feel the full benefits. Most people must take Flovent every day. However, according to updated recommendations for asthma management by the National Institutes of Health (NIH) issued in December 2020, this may not be necessary for those with mild to moderate persistent asthma. If you use an inhaler daily to manage asthma, talk to your healthcare provider about how the new guidelines might affect your treatment.

If you feel your asthma control is good, you can speak to your healthcare provider about decreasing the strength of your daily dose.

If Flovent is unable to control your symptoms, let your healthcare provider know. If needed, a long-acting beta-agonist may be added to your daily treatment plan, or an oral corticosteroid may be recommended if your asthma attacks are severe and recurrent.

Both Flovent HFA and Flovent Diskus can be stored at room temperature between 68 and 77 degrees F. Keep Flovent HFA away from open flames and other heat sources and do not puncture the container. Keep both medications out of the view and reach of children.

Because Flovent HFA and Flovent Diskus have different types of delivery, instructions for use differ. Speak to your healthcare provider or pharmacist if you are unsure if you are using your Flovent inhaler properly.

Using Flovent HFA:

1. When using the inhaler for the first time (or if you've not used it in four weeks), prime it by spraying it into the air four times. You only need to spray it once if not used within one to three weeks.
2. Shake the inhaler vigorously for five seconds.
3. Take the cap off and, if you use one, place a spacer on the end.
4. Exhale fully and place the mouthpiece in your mouth in a downward position, wrapping your lips tightly to form a seal.
5. Breathe in deeply through your mouth as you simultaneously depress the inhaler completely.
6. Hold your breath for about 10 seconds and exhale slowly.
7. If additional doses are needed, wait 30 seconds, shake the inhaler, and start again.
8. Once completed, rinse your mouth. Do not swallow.
9. Replace the cap.

Clean the mouthpiece and spacer at least once a week. When the dose counter reads "020," it's time for a refill.

Using Flovent Diskus:

1. Push down the thumb grip at the top as far as it can go to open the disk.
2. Hold the disk level with the mouthpiece so that it faces you.
3. Slide the lever next to the mouthpiece down until it clicks. This loads the precise dose into the well of the actuator.
4. Hold the disk away from your face and exhale fully.
5. Place your mouth tightly over the mouthpiece and inhale as deeply as you can.
6. Remove your mouth from the mouthpiece, holding your breath for around 10 seconds.
7. Exhale slowly and fully.
8. If additional doses are needed, repeat the above steps.
9. Close the mouthpiece cover when finished.

When the dose counter on the disk reads "5," refill your prescription. Do not wash the inhaler. Always keep it dry.

If you miss a dose of Flovent HFA or Flovent Diskus, take it as soon as possible. However, if it is near the time of your next dose, skip the missed dose and go back to your regular dosing schedule. Never double up doses.

While using Flovent is generally safe, Flovent does carry some risk of side effects, most of which diminish the longer you use it. If side effects persist or worsen, let your healthcare provider know.

The side effects of Flovent HFA and Flovent Diskus are similar. While Flovent Diskus has fewer constitutional symptoms, comparatively speaking, Flovent HFA has far less risk of oral candidiasis (thrush) due to the use of spacers.

The most common side effects of Flovent HFA and Flovent Diskus (in order of frequency):

Flovent HFA

• Upper respiratory infection

• Throat irritation

• Headache

• Sinus infection

• Nausea and vomiting

• Fever (usually mild)

• Sneezing and runny nose

• Stomach ache

• Muscle and joint pain

Flovent Diskus

• Upper respiratory infection

• Headache

• Throat irritation

• Sinus infection

• Oral candidiasis (thrush)

• Cough

While Flovent is considered safe with relatively few intolerable side effects, it can cause problems with long-term use. Some may relate to the development of cataracts, glaucoma, bone mineral loss, or adrenal dysfunction that can occur, albeit uncommonly, in Flovent users.

Call your healthcare provider if you experience any of the following while using either Flovent HFA or Flovent Diskus:

• Blurred vision
• Eye pain
• Vision loss
• Erectile dysfunction
• Irregular or missed periods
• Shortness of breath or wheezing
• High fever
• Bone fractures
• Severe weakness
• Confusion or disorientation

Seek emergency care if you experience symptoms of anaphylaxis after using Flovent:

• Rash or hives
• Shortness of breath
• Wheezing
• Rapid or irregular heartbeat
• Dizziness or lightheadedness
• Swelling of the face, tongue, or throat
• A feeling of impending doom

If left untreated, anaphylaxis can lead to shock, coma, asphyxiation, heart or respiratory failure, or death.

Because Flovent can suppress the immune system, children may also be at greater risk of communicable infection, so parents should try to prevent exposure to diseases like measles or chickenpox. If there is an outbreak in your child's school or your child gets infected, contact their healthcare provider immediately for advice on what to do.

Stop taking Flovent if you develop oral thrush as the medication can make it worse. You should call your asthma healthcare provider if you develop a respiratory infection, particularly a lower respiratory infection, as you may also need to stop treatment temporarily.

In the body, Flovent HFA and Flovent Diskus are both metabolized by an enzyme called cytochrome P450 (CYP450). Because of this, it may interact with other drugs that are metabolized by the same enzyme. If this occurs, the concentration of one or both drugs can rise or drop.

A decrease in drug concentration may reduce the effectiveness of a drug, while an increase can increase the risk of side effects.

Drugs of potential concern include:

Some interactions may require a drug substitution, a dose reduction, or the separation of each dose by several hours to avoid an interaction. Others may require no adjustment at all.

Because of the wide range of possible interactions, it is important to let your healthcare provider9 know about any drugs you are taking, whether they are prescription, over-the-counter, herbal, nutritional, or recreational.

Flovent HFA and Flovent Diskus are both valuable medications for gaining control of your asthma symptoms, but they only work if you take them as prescribed. If you have problems adhering to your asthma plan, talk to your healthcare provider about ways to make it easier for you to stick to your protocol.

If your symptoms are not controlled, it's possible you've been taking the drug incorrectly. In other cases, your healthcare provider may opt to change you to a once-daily inhaler like Breo Ellipta if appropriate.