Skip to main content

Advair Diskus Side Effects

Generic name: fluticasone / salmeterol

Medically reviewed by Drugs.com. Last updated on Aug 15, 2023.

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 Diskus.

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

Serious side effects of Advair Diskus

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

Incidence not known

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

Symptoms of overdose

Other side effects of Advair Diskus

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

Less common

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]

Frequently asked questions

References

1. Brogden RN, Faulds D. Salmeterol xinafoate. A review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs. 1991;42:895-912.

2. Salmeterol. Med Lett Drugs Ther. 1994;36:37-9.

3. Product Information. Serevent (salmeterol). Glaxo Wellcome. PROD.

4. Nathan RA, Seltzer JM, Kemp JP, Chervinsky P, Alexander WJ, Liddle R, Mills R. Safety of salmeterol in the maintenance treatment of asthma. Ann Allergy Asthma Immunol. 1995;75:243-8.

5. Lorentzen KA, Vanhelmond JLM, Bauer K, Langaker KE, Bonifazi F, Harris TAJ. Fluticasone propionate 1 mg daily and beclomethasone dipropionate 2 mg daily: a comparison over 1 yr. Respir Med. 1996;90:609-17.

6. Product Information. Advair Diskus (fluticasone-salmeterol). Glaxo Wellcome. 2001;PROD.

7. Cerner Multum, Inc. UK Summary of Product Characteristics.

8. Cerner Multum, Inc. Australian Product Information.

9. D'Alonzo GE, Nathan RA, Henochowicz S, Morris RJ, Ratner P, Rennard SI. Salmeterol xinafoate as maintenance therapy compared with albuterol in patients with asthma. JAMA. 1994;271:1412-6.

10. Kemp JP, Bierman CW, Cocchetto DM. Dose-response study of inhaled salmeterol in asthmatic patients with 24-hour spirometry and Holter monitoring. Ann Allergy. 1993;70:316-22.

11. Pearlman DS, Chervinsky P, LaForce C, Seltzer JM, Southern DL, Kemp JP, Dockhorn RJ, Grossman J, Liddle RF, Yancey SW, et al. A comparison of salmeterol with albuterol in the treatment of mild-to- moderate asthma. N Engl J Med. 1992;327:1420-5.

12. Meyer JM, Wenzel CL, Kradjan WA. Salmeterol: a novel, long-acting beta 2-agonist. Ann Pharmacother. 1993;27:1478-87.

13. Maconochie JG, Forster JK. Dose-response study with high-dose inhaled salmeterol in healthy subjects. Br J Clin Pharmacol. 1992;33:342-5.

14. Lopezguillen A, Marques L, Lopezllorente MT, Pastor E, Figueras A. Salmeterol-induced vertigo. Eur Respir J. 1994;7:2089-90.

15. Barnes PJ. Drug therapy: inhaled glucocorticoids for asthma. N Engl J Med. 1995;332:868-75.

16. Mann RD, Kubota K, Pearce G, Wilton L. Salmeterol: a study by prescription-event monitoring in a UK cohort of 15,407 patients. J Clin Epidemiol. 1996;49:247-50.

17. Product Information. Flovent (fluticasone). Glaxo Wellcome. 2001;PROD.

18. Wilkinson JR, Roberts JA, Bradding P, Holgate ST, Howarth PH. Paradoxical bronchoconstriction in asthmatic patients after salmeterol by metered dose inhaler. BMJ. 1992;305:931-2.

19. Clark CE, Ferguson AD, Siddorn JA. Respiratory arrests in young asthmatics on salmeterol. Respir Med. 1993;87:227-8.

20. Dottorini ML, Tantucci C, Peccini F, Grassi V, Sorbini CA. Diurnal change of bronchial caliber and airway responsiveness in asthmatics during long-term treatment with long-acting beta 2-agonist salmeterol. Int J Clin Pharmacol Ther. 1996;34:438-43.

21. Maconochie JG, Minton NA, Chilton JE, Keene ON. Does tachyphylaxis occur to the non-pulmonary effects of salmeterol? Br J Clin Pharmacol. 1994;37:199-204.

22. Britton MG, Earnshaw JS, Palmer JB. A twelve month comparison of salmeterol with salbutamol in asthmatic patients. European Study Group [published erratum appears in Eur Respir J 1993;6(1):150]. Eur Respir J. 1992;5:1062-7.

23. Ullman A, Svedmyr N. Salmeterol comparison with salbutamol in adult asthmatic patients. Thorax. 1988;43:674-8.

24. Tranfa CME, Pelaia G, Grembiale RD, Naty S, Durante S, Borrello G. Short-term cardiovascular effects of salmeterol. Chest. 1998;113:1272-6.

25. Holliday SM, Faulds D, Sorkin EM. Inhaled fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma. Drugs. 1994;47:318-31.

26. Paggiaro PL, Dahle R, Bakran I, Frith L, Hollingworth K, Efthimiou J. Multicenter randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. Lancet. 1998;351:773-80.

27. Executive Committee American Academy of Allergy and Immunology. Inhaled corticosteroids and severe viral infections. J Allergy Clin Immunol. 1993;92:223-8.

28. Packe GE, Douglas JG, McDonald AF, Robins SP, Reid DM. Bone density in asthmatic patients taking high dose inhaled beclomethasone diproprionate and intermittent systemic corticosteroids. Thorax. 1992;47:414-7.

29. Garbe E, LeLorier J, Boivin JF, Suissa S. Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma. JAMA. 1997;277:722-7.

30. Svedmyr N, Lofdahl CG. The use of beta(2)-adrenoceptor agonists in the treatment of bronchial asthma. Pharmacol Toxicol. 1996;78:3-11.

31. Booth H, Bish R, Walters J, Whitehead F, Walters EH. Salmeterol tachyphylaxis in steroid treated asthmatic subjects. Thorax. 1996;51:1100-4.

32. Hatton MQ, Allen MB, Mellor EJ, Cooke NJ. Salmeterol rash . Lancet. 1991;337:1169-70.

33. Grahnen A, Eckernas SA, Brundin RM, Lingandersson A. An assessment of the systemic activity of single doses of inhaled fluticasone propionate in healthy volunteers. Br J Clin Pharmacol. 1994;38:521-5.

34. Howland WC. Fluticasone propionate: topical or systemic effects? Clin Exp Allergy. 1996;26 ( Suppl:18-22.

35. Clark DJ, Lipworth BJ. Adrenal suppression with chronic dosing of fluticasone propionate compared with budesonide in adult asthmatic patients. Thorax. 1997;52:55-8.

36. Thorsson L, Dahlstrom K, Edsbacker S, Kallen A, Paulson J, Wiren JE. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol. 1997;43:155-61.

37. Derom E, Schoor JV, Verhaeghe W, Vincken W, Pauwels R. Systemic effects of inhaled fluticasone propionate and budesonide in adult patients with asthma. Am J Respir Crit Care Med. 1999;160:157-61.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.