Serevent Diskus Side Effects

Generic Name: salmeterol

Note: This page contains side effects data for the generic drug salmeterol. It is possible that some of the dosage forms included below may not apply to the brand name Serevent Diskus.

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

For the Consumer

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

As well as its needed effects, salmeterol (the active ingredient contained in Serevent Diskus) may cause unwanted side effects that require medical attention.

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

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

General

Salmeterol is usually well-tolerated and adverse effects seen are consistent with its pharmacological action. In general, the severity of these adverse effects are dependent on dose. Tolerance to the adverse effects of salmeterol (the active ingredient contained in Serevent Diskus) can occur.[Ref]

Cardiovascular

The cardiovascular system side effects have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. Blood pressure has increased and decreased. Higher doses have rarely aggravated angina, myocardial ischemia, or caused atrial or ventricular arrhythmias.[Ref]

Changes in heart rate of approximately 8 to 16 beats per minute may be produced by 0.2 mg of salmeterol given by MDI. At an inhaled dose of 0.4 mg, two subjects have experienced nonspecific T-wave changes, and one subject experienced QT prolongation. Higher doses of salmeterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.[Ref]

Musculoskeletal

Musculoskeletal side effects have included tremors, especially at higher doses. Tolerance has developed to the tremorogenic effects. Severe muscle cramping is rarely reported.[Ref]

Metabolic

Metabolic side effects have included hypokalemia, and less commonly hyperglycemia.[Ref]

Following a 400-mcg dose of salmeterol via MDI, a decrease in plasma potassium concentrations of 0.45 mEq/L has been reported. Salmeterol may stimulate sodium-potassium ATPase resulting in an intracellular shift of potassium.[Ref]

Nervous system

One patient has reported episodes of vertigo lasting 36 hours each following inhalation of salmeterol (the active ingredient contained in Serevent Diskus) These episodes occurred several months apart during separate attempts to reinstitute therapy.[Ref]

The nervous system side effects have included headache, restlessness, anxiety, nervousness, irritability, and insomnia.[Ref]

Respiratory

Respiratory side effects have included cough, paradoxical bronchospasm, and oropharyngeal irritation.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.[Ref]

Hypersensitivity

Hypersensitivity reactions have included rash or urticaria.[Ref]

Other

Concern over the development of tachyphylaxis to the bronchodilating and bronchoprotective effects of beta-agonists has been expressed. Although conflicting data exist, the development of complete tolerance has not been reported.[Ref]

References

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

2. 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 75 (1995): 243-8

3. 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

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

5. 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

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

7. 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

8. 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

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

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

11. 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

12. 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

13. 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

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

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

16. 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

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

18. 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

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

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

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

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