What side effects are possible with this medication?
A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect cannot be anticipated. It can be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.
- colds, sinus infections, mouth infections, or throat infections
- hoarseness, voice changes
- muscle and bone pain
- nausea, diarrhea, or vomiting
- throat irritation
to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Bones: The long-term effects of this medication on bone density are not known. Talk to your doctor about your risk for osteoporosis (brittle bones).
Glaucoma: If you have glaucoma, have your eye pressure tested before starting long-term treatment with this medication, and have your eye pressure monitored at regular intervals while using this medication.
Heart disease: If you have heart disease, irregular heartbeat, or high blood pressure, your doctor should monitor your condition closely while you are taking this medication.
Increased risk of asthma-related death: One of the active ingredients, salmeterol, may increase your risk of dying as a result of asthma. Get immediate emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler medicine but it does not relieve your breathing problem. Discuss the proper treatment of your asthma with your doctor and always be aware of the signs and symptoms of worsening asthma. Salmeterol should not be used to treat an asthma attack. It is not intended to be used alone as a substitute for corticosteroid inhalers. Do not stop taking your salmeterol without checking with your doctor first.
Medical conditions: If you have any of the following:
- immune system problems
- a seizure disorder
- liver disease
- a thyroid disorder
discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Serious allergic reactions: Call your doctor or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash, hives, swelling of the face, mouth, and tongue, or sudden breathing problems immediately after inhaling the medication.
Thrush: Fluticasone may cause an increased risk of thrush infection in the mouth and throat. To prevent infection, gargle with water after each use of this medication.
Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening asthma):
- after a change in your asthma medicines you have any worsening of your asthma symptoms or an increase in the need for your rescue inhaler medicine
- your short-acting inhaled bronchodilators are less effective (less than 4 hours of relief)
- a peak flow meter shows results in the below-normal range
- you have asthma and your symptoms do not improve after using this medication regularly for 1 week
- you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row
- you use 1 whole canister of your rescue inhaler medicine in 8 weeks' time
Pregnancy: The safety of this medication for use during pregnancy has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.
Breast-feeding: It is not known if this medication passes into breast milk. Women should stop breast-feeding while they are taking this medication.
Children: The safety and effectiveness of this medication have not been established for children under 4 years of age. This medication may increase the risk of asthma-related hospitalization in children and adolescents.
What other drugs could interact with this medication?
There may be an interaction between salmeterol - fluticasone and any of the following:
- beta-blocking medications (e.g., propranolol, metoprolol, atenolol, labetalol)
- certain antidepressants: monoamine oxidase inhibitors (e.g., phenelzine, tranylcypromine) and tricyclic antidepressants (e.g., imipramine, amitriptyline) only
- medications that cause low potassium (e.g., hydrochlorothiazide, furosemide, high doses of prednisone)
- other long-acting inhaled asthma medications (e.g., formoterol)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.