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Advair Diskus Side Effects

Generic Name: fluticasone / salmeterol

Note: This page contains information about the side effects of fluticasone / salmeterol. Some of the dosage forms included on this document may not apply to the brand name Advair Diskus.

Not all side effects for Advair Diskus may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by fluticasone / salmeterol. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea or vomiting
  • noisy breathing
  • painful or difficult urination
  • sensation of pins and needles
  • shortness of breath
  • skin itching, rash, or redness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain in the arms or legs
  • swelling of the face, throat, or tongue
  • swollen glands
  • tearing
  • unusual bleeding or bruising
  • wheezing
Incidence not known
  • Abdominal or stomach pain
  • 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
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • weight gain

If any of the following symptoms of overdose occur while taking fluticasone / salmeterol, get emergency help immediately:

Symptoms of overdose
  • Chest pain or tightness
  • confusion
  • convulsions (seizures)
  • 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
  • sudden sweating
  • tremors
  • trouble with sleeping

Some of the side effects that can occur with fluticasone / salmeterol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • flu-like symptoms
  • 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]

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