Note: This document contains side effect information about fluticasone / salmeterol. Some dosage forms listed on this page may not apply to the brand name Advair HFA.

Applies to fluticasone / salmeterol: inhalation aerosol liquid, inhalation disk, inhalation powder.

Serious side effects of Advair HFA

Along with its needed effects, fluticasone/salmeterol 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 while taking fluticasone / salmeterol:

More common

• Black, tarry stools
• blindness
• blurred vision
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• chills
• cough
• decreased vision
• difficulty with breathing or swallowing
• eye pain
• fast heartbeat
• fever
• headache
• hives or welts, skin itching, rash, or redness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• noisy breathing
• painful or difficult urination
• sensation of pins and needles
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stabbing pain in the arms or legs
• swollen glands
• tearing
• unusual bleeding or bruising
• vomiting

Incidence not known

• Backache
• bruising
• darkening of the skin
• decrease in height
• diarrhea
• difficulty with moving
• dizziness
• facial hair growth in females
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heavy bleeding
• increased hunger
• increased thirst or urination
• irritability
• large, flat, blue, or purplish patches in the skin
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle pain or stiffness
• muscle wasting
• pain in the back, ribs, arms, or legs
• pain in the joints
• stomach pain
• sweating
• unexplained weight loss
• unusual tiredness or weakness
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone / salmeterol:

Symptoms of overdose

• Chest pain or tightness
• confusion
• decreased urine output
• dry mouth
• faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• general feeling of discomfort or illness
• high blood pressure
• loss of appetite
• mood changes
• nervousness
• numbness or tingling in the hands, feet, or lips
• seizures
• sudden sweating
• tremors
• trouble with sleeping

Other side effects of Advair HFA

Some side effects of fluticasone / salmeterol 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:

More common

• Body aches or pain
• choking
• congestion
• dryness of the throat
• high-pitched noise when breathing
• hoarseness
• runny nose
• sneezing
• trouble with swallowing
• voice changes

Less common

• Cough-producing mucus
• irritation or inflammation of the eye
• muscle pain
• pain or tenderness around the eyes and cheekbones
• sleep disorders
• stuffy nose
• white patches in the mouth or throat or on the tongue

For Healthcare Professionals

Applies to fluticasone / salmeterol: inhalation aerosol, inhalation powder.

General

The most common events that occurred more frequently were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 21%)

Common (1% to 10%): Migraine

Uncommon (0.1% to 1%): Tremor

Postmarketing reports: Paraesthesia, restlessness, compressed nerve syndrome, aphonia^[Ref]

Respiratory

The incidence of pneumonia was higher in adult subjects with COPD older than 65 years compared with younger subjects with COPD (18% versus 14%).^[Ref]

Very common (10% or more): Upper respiratory tract infections (up to 27%), pharyngitis (up to 13%), nasopharyngitis

Common (1% to 10%): Pneumonia, bronchitis, throat irritation, hoarseness, dysphonia, sinusitis, upper respiratory inflammation, viral respiratory infections, cough, rhinorrhea/postnasal drip, epistaxis, nasal congestion/blockage, laryngitis, unspecified oropharyngeal plaques, dryness of nose, lower respiratory signs and symptoms, lower respiratory infections, lower respiratory hemorrhage, congestion

Uncommon (0.1% to 1%): Dyspnea

Rare (less than 0.1%): Oropharyngeal angioedema, bronchospasm, paradoxical bronchospasm

Frequency not reported: Nose, and throat infections, laryngitis, nasal sinus disorders, nasal sinus disorders

Postmarketing reports: Paranasal sinus pain, rhinitis, throat soreness, tonsillitis, asthma, asthma exacerbation, chest congestion, chest tightness, tracheitis, wheezing, report of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or chocking^[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, tachycardia, arrhythmias, myocardial infarction, postoperative complications

Uncommon (0.1% to 1%): Atrial fibrillation, angina pectoris

Rare (less than 0.1%): Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles)

Frequency not reported: Hematomas

Postmarketing reports: Ventricular tachycardia, pallor^[Ref]

Dermatologic

Common (1% to 10%): Contusions, wounds, eczema, dermatitis, dermatosis

Frequency not reported: Skin flakiness and acquired ichthyosis, disorders of sweat and sebum

Postmarketing reports: Ecchymoses, photodermatitis^[Ref]

Gastrointestinal

Common (1% to 10%): Oral and throat candidiasis, nausea and vomiting, gastrointestinal discomfort and pain, dental discomfort and pain, hyposalivation, gastrointestinal infections, disorders of hard tissue of teeth, abdominal discomfort and pain, oral abnormalities, gastrointestinal discomfort and pain, viral gastrointestinal infections, diarrhea

Rare (less than 0.1%): Esophageal candidiasis

Frequency not reported: Oral lesions

Postmarketing reports: Oral ulcerations, dyspepsia, xerostomia^[Ref]

Immunologic

Common (1% to 10%): Allergies and allergic reactions^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, weight gain

Uncommon (0.1% to 1%): Hyperglycemia

Frequency not reported: Fluid retention^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps, traumatic fractures, arthralgia, myalgia, arthralgia, articular rheumatism, muscle spasms, musculoskeletal inflammation, bone and skeletal pain, muscle injuries, soft tissue injuries

Postmarketing reports: Muscle stiffness, tightness and rigidity, bone and cartilage disorders, myositis, osteoporosis, fractures^[Ref]

Ocular

Common (1% to 10%): Allergic eye disorders, eye edema and swelling

Uncommon (0.1% to 1%): Cataract

Rare (less than 0.1%): Glaucoma

Frequency not reported: Dry eyes, eye infections, keratitis, conjunctivitis^[Ref]

Other

Common (1% to 10%): Candidiasis unspecified site, ear signs and symptoms, viral infections, bacterial infections, inflammation, bacterial reproductive infections

Rare (less than 0.1%): Angioedema, facial angioedema

Frequency not reported: Syncope, edema and swelling, dysmenorrhea, pain, unusual taste, lacerations

Postmarketing reports: Ear ache, fever^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Cutaneous hypersensitivity reactions

Rare (less than 0.1%): Anaphylactic reactions including anaphylactic shock^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, sleep disorders

Rare (less than 0.1%): Behavioral changes, including psychomotor hyperactivity and irritability (predominately in children)

Frequency not reported: Depression, aggression (predominantly in children)

Postmarketing reports: Agitation^[Ref]

Endocrine

Rare (less than 0.1%): Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease bone mineral density

Frequency not reported: Hypothyroidism

Postmarketing reports: Hypercorticism^[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests^[Ref]