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Salmeterol Side Effects

In Summary

More frequently reported side effects include: influenza, pharyngitis, skin rash, and ear sign or symptom. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to salmeterol: inhalation aerosol powder, inhalation disk, inhalation powder

As well as its needed effects, salmeterol may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking salmeterol, check with your doctor immediately:

More common:
  • Cough producing mucus
  • difficulty with breathing
  • headache
  • irritation of the throat
  • runny nose
  • shortness of breath
  • sneezing
  • stuffy nose
  • tightness in the chest
  • wheezing
Less common:
  • Abdominal or stomach pain
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • colds
  • cough or hoarseness
  • diarrhea
  • difficulty breathing
  • dizziness
  • dry mouth
  • fever
  • flu-like symptoms
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pain
  • pain or tenderness around the eyes and cheekbones
  • pounding in the ears
  • shivering
  • slow or fast heartbeat
  • sore mouth or tongue
  • sore throat
  • sweating
  • swelling
  • trouble with sleeping
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • white patches in the mouth or on the tongue

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

Symptoms of overdose:
  • Arm, back, or jaw pain
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • fast or irregular heartbeat
  • fast, slow, pounding, or irregular heartbeat or pulse
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • sleeplessness
  • trembling or shaking of the hands or feet
  • unable to sleep

Minor Side Effects

Some salmeterol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:
  • Acid or sour stomach
  • anxiety
  • belching
  • blistering, burning, crusting, dryness, or flaking of the skin
  • bone pain
  • burning, dry, or itching eyes
  • difficulty with moving
  • discharge or excessive tearing
  • eye redness, irritation, or pain
  • headache, severe and throbbing
  • heartburn
  • hives or welts
  • indigestion
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • mouth or tooth pain
  • muscle cramps and spasm
  • muscle stiffness or tightness
  • redness of the skin
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • skin rash
  • skin rash, encrusted, scaly and oozing
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to salmeterol: inhalation aerosol, inhalation aerosol with adapter, inhalation powder

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (12%)
Common (1% to 10%): Arthralgia, articular rheumatism, muscle cramps and spasm, bone and skeletal pain, muscle pain, muscle stiffness, muscle tightness, muscle rigidity, musculoskeletal inflammation
Frequency not reported: Join pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 14%)
Common (1% to 10%): Dizziness, migraines, tremor
Frequency not reported: Sinus headache, paresthesia[Ref]

Cardiovascular

Common (1% to 10%): Pallor, hypertension, palpitations
Uncommon (0.1% to 1%): Tachycardia
Very rare (less than 0.01%): Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)
Frequency not reported: Peripheral vasodilation and a compensatory small increase in heart rate[Ref]

Dermatologic

Common (1% to 10%): Skin rashes, urticaria, photodermatitis
Frequency not reported: Contact dermatitis, eczema[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal signs and symptoms, nausea, vomiting, candidiasis mouth/throat, dental discomfort and pain, dyspeptic symptoms, gastrointestinal infections, hyposalivation
Frequency not reported: Oral mucosal abnormality[Ref]

Hepatic

Common (1% to 10%): Transient elevation of hepatic enzymes[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Rare (less than 0.1%): Hypokalemia[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, keratitis[Ref]

Other

Common (1% to 10%): Influenza, ear signs and symptoms, edema and swelling
Frequency not reported: Localized aches and pains, pyrexia of unknown origin[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Nervousness
Rare (less than 0.1%): Insomnia
Frequency not reported: Sleep disturbances[Ref]

Respiratory

Common (1% to 10%): Nasal/sinus congestion, rhinitis, asthma, tracheitis/bronchitis, pharyngitis, sinusitis, upper respiratory tract infection, cough, throat irritation, lower respiratory signs and symptoms
Very rare (less than 0.01%): Paradoxical bronchospasm, non specific chest pain, oropharyngeal irritation
Frequency not reported: Bronchospasm
Postmarketing reports: Upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions including edema and angioedema, bronchospasm and anaphylactic shock
Frequency not reported: Immediate hypersensitivity reactions
Postmarketing reports: Anaphylaxis[Ref]

References

1. "Product Information. Severent (salmeterol)." Glaxo Wellcome, Research Triangle Park, NC.

2. 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 49 (1996): 247-50

3. 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 5 (1992): 1062-7

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

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

6. "Salmeterol." Med Lett Drugs Ther 36 (1994): 37-9

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

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

9. 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 327 (1992): 1420-5

10. 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 271 (1994): 1412-6

11. Cerner Multum, Inc. "Australian Product Information." O 0

12. Ullman A, Svedmyr N "Salmeterol comparison with salbutamol in adult asthmatic patients." Thorax 43 (1988): 674-8

13. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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

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

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

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

19. 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 34 (1996): 438-43

20. Clark CE, Ferguson AD, Siddorn JA "Respiratory arrests in young asthmatics on salmeterol." Respir Med 87 (1993): 227-8

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

22. Hatton MQ, Allen MB, Mellor EJ, Cooke NJ "Salmeterol rash ." Lancet 337 (1991): 1169-70

It is possible that some side effects of salmeterol may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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