Proventil Side Effects

Generic Name: albuterol

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

It is possible that some side effects of Proventil 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 albuterol: oral syrup, oral tablet, oral tablet extended release

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

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

More common
  • Shakiness in the legs, arms, hands, or feet
  • trembling or shaking of the hands or feet
Less common
  • Fast, irregular, pounding, or racing heartbeat or pulse
Rare
  • Cough
  • difficulty breathing
  • difficulty with swallowing
  • hives or welts
  • hoarseness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • redness of the skin
  • shortness of breath
  • skin rash
  • slow or irregular breathing
  • swelling of the mouth or throat
  • tightness in the chest
  • wheezing
Incidence not known
  • Agitation
  • anxiety
  • arm, back, or jaw pain
  • blurred vision
  • chest pain or discomfort
  • confusion
  • convulsions
  • extra heartbeats
  • fainting
  • hallucinations
  • headache
  • irritability
  • lightheadedness
  • mood or mental changes
  • muscle pain or cramps
  • muscle spasm or jerking of all extremities
  • nervousness
  • nightmares
  • pounding in the ears
  • restlessness
  • sudden loss of consciousness
  • sweating
  • total body jerking
  • unusual feeling of excitement
  • vomiting

Some albuterol 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
  • Dizziness
  • feeling of warmth
  • irritability
  • nausea
  • redness of the face, neck, arms, and occasionally, upper chest
  • sleeplessness
  • trouble with holding or releasing urine
  • trouble sleeping
  • unable to sleep
Rare
  • Sleepiness
  • unusual drowsiness
Incidence not known
  • Bad, unusual, or unpleasant (after) taste
  • change in taste
  • feeling of constant movement of self or surroundings
  • gagging
  • rough, scratchy sound to voice
  • sensation of spinning
  • tightness in the throat

For Healthcare Professionals

Applies to albuterol: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation capsule, inhalation solution, oral syrup, oral tablet, oral tablet extended release

General

Albuterol is generally well-tolerated and adverse effects seen are consistent with its pharmacological activity. In general, the severity of these adverse effects is dependent on the dose and route of administration. Administration by metered-dose inhaler (MDI) is associated with less systemic effects than administration of higher dosages orally or by nebulizer. Tolerance may develop to the adverse effects of albuterol (the active ingredient contained in Proventil) [Ref]

Cardiovascular

Changes in heart rate of approximately 20% may be produced by 0.18 mg of albuterol (the active ingredient contained in Proventil) by MDI. Aggravation of angina may be due to tachycardia produced by albuterol. Atrial fibrillation was reported in one patient when a spacer device was utilized with an albuterol inhaler, thus increasing the available dose for systemic absorption. Supraventricular ectopic beats and ventricular tachycardia have also been reported. Higher doses of albuterol 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]

The cardiovascular side effects have included palpitations, peripheral vasodilatation and reflex tachycardia with blood pressure increasing or decreasing. Albuterol in higher dosages has been reported to aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias. Pulmonary edema has been reported in pregnant patients receiving intravenous albuterol. Postmarketing reports have included hypotension.[Ref]

Musculoskeletal

Musculoskeletal side effects have included tremors, particularly at higher dosages. Tolerance can develop to the tremorogenic effects. Severe muscle cramping may occur infrequently.[Ref]

Metabolic

Following doses of 15 mg albuterol (the active ingredient contained in Proventil) via nebulizer, hyperkalemic patients on hemodialysis experienced a 0.9 mEq/L decrease in plasma potassium which was sustained for 6 hours. Albuterol may stimulate sodium-potassium ATPase, resulting in an intracellular shift of potassium.

Transient lactic acidosis has been reported after administration of inhaled albuterol for an asthma attack.[Ref]

Metabolic side effects have included hypokalemia, and less commonly, hyperglycemia and lactic acidosis. Postmarketing reports have included metabolic acidosis. Diabetic ketoacidosis has been reported due to overdose of albuterol.[Ref]

Nervous system

Nervous system side effects have included restlessness, anxiety, nervousness, irritability, and insomnia. Postmarketing reports have included tremor.[Ref]

Psychiatric

Psychiatric side effects have included psychoses presenting as auditory hallucinations and persecutory delusions. These effects are generally associated with higher dosages.[Ref]

Other

Concern over the development of tachyphylaxis to the bronchodilating effects of albuterol (the active ingredient contained in Proventil) has been expressed. Although conflicting data exist, complete tolerance has not been reported.[Ref]

Respiratory

Respiratory side effects have included paradoxical bronchospasm.[Ref]

References

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2. Larsson S, Svedmyr N "Bronchodilating effect and side effects of beta2- adrenoceptor stimulants by different modes of administration (tablets, metered aerosol, and combinations thereof). A study with salbutamol inasthmatics." Am Rev Respir Dis 116 (1977): 861-9

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4. Godfrey S "Worldwide experience with albuterol (salbutamol)." Ann Allergy 47 (1981): 423-6

5. Meyer MF, Hopkins WE, Kaminsky DA "Cardiovascular collapse in a 77-year-old-woman with an asthma exacerbation following bronchodilator treatment." Chest 124 (2003): 1160-3

6. Vathenen AS, Britton JR, Ebden P, Cookson JB, Wharrad HJ, Tattersfield AE "High-dose inhaled albuterol in severe chronic airflow limitation." Am Rev Respir Dis 138 (1988): 850-5

7. Breeden CC, Safirstein BH "Albuterol and spacer-induced atrial fibrillation." Chest 98 (1990): 762-3

8. Kallergis EM, Manios EG, Kanoupakis EM, et al. "Acute electrophysiologic effects of inhaled salbutamol in humans." Chest 127 (2005): 2057-63

9. Jenne JW "Can oral beta(2) agonists cause heart failure?" Lancet 352 (1998): 1081-2

10. Davies AE, Robertson MJ "Pulmonary oedema after the administration of intravenous salbutamol and ergometrine. Case report." Br J Obstet Gynaecol 87 (1980): 539-41

11. Hawker F "Five cases of pulmonary oedema associated with beta 2-sympathomimetic treatment of premature labour." Anaesth Intensive Care 12 (1984): 159-62

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13. Mettauer B, Rouleau JL, Burgess JH "Detrimental arrhythmogenic and sustained beneficial hemodynamic effects of oral salbutamol in patients with chronic congestive heart failure." Am Heart J 109 (1985): 840-7

14. Shovlin CL, Tam FW "Salbutamol nebuliser and precipitation of critical cardiac ischaemia." Lancet 336 (1990): 1258

15. Lipworth BJ, Struthers AD, McDevitt DG "Tachyphylaxis to systemic but not to airway responses during prolonged therapy with high dose inhaled salbutamol in asthmatics." Am Rev Respir Dis 140 (1989): 586-92

16. Chazan R, Droszcz W, Maruchin JE "Pharmacodynamics of salbutamol in humans." Int J Clin Pharmacol Ther Toxicol 26 (1988): 385-7

17. Finch JS "Cardiovascular toxicity: clinical evaluation of albuterol, isoproterenol and placebo in rising dose tolerance trial." Ann Allergy 47 (1981): 402-4

18. Wong CS, Pavord ID, Williams J, Britton JR, Tattersfield AE "Bronchodilator, cardiovascular, and hypokalaemic effects of fenoterol, salbutamol, and terbutaline in asthma." Lancet 336 (1990): 1396-9

19. Tan SN "Peri-partum pulmonary oedema." Anaesth Intensive Care 19 (1991): 111-3

20. Larsson S "Long-term treatment with beta2-adrenostimulants in asthma. Side effects, selectivity, tolerance, and routes of administration." Acta Med Scand Suppl 608 (1977): 1-40

21. Lisi DM "Muscle spasms and creatine phosphokinase elevation following salbutamol administration." Eur Respir J 2 (1989): 98

22. Craig TJ, Smits W, Soontornniyomkiu V "Elevation of creatine kinase from skeletal muscle associated with inhaled albuterol." Ann Allergy Asthma Immunol 77 (1996): 488-90

23. Stratakos G, Kalomenidis J, Routsi C, Papiris S, Roussos C "Transient lactic acidosis as a side effect of inhaled salbutamol." Chest 122 (2002): 385-6

24. Kantola I, Tarssanen L "Hypokalemia from usual salbutamol dosage ." Chest 89 (1986): 619-20

25. Hastwell G, Lambert BE "The effect of oral salbutamol on serum potassium and blood sugar." Br J Obstet Gynaecol 85 (1978): 767-9

26. Rakhmanina NY, Kearns GL, Farrar HC "Hypokalemia in an asthmatic child from abuse of albuterol metered dose inhaler." Pediatr Emerg Care 14 (1998): 145-7

27. Allon M, Dunlay R, Copkney C "Nebulized albuterol for acute hyperkalemia in patients on hemodialysis." Ann Intern Med 110 (1989): 426-9

28. Montoliu J, Almirall J, Ponz E, Campistol JM, Revert L "Treatment of hyperkalaemia in renal failure with salbutamol inhalation." J Intern Med 228 (1990): 35-7

29. "Hypokalaemia due to salbutamol overdosage." Br Med J (Clin Res Ed) 283 (1981): 500-1

30. Habib GS, Saliba WR, Cohen L "Diabetic ketoacidosis associated with oral salbutamol overdose." Am J Med 113 (2002): 701-2

31. Liem EB, Mnookin SC, Mahla ME "Albuterol-induced Lactic Acidosis." Anesthesiology 99 (2003): 505-506

32. Whyte KF, Addis GJ, Whitesmith R, Reid JL "The mechanism of salbutamol-induced hypokalaemia." Br J Clin Pharmacol 23 (1987): 65-71

33. Whitehouse AM, Novosel S "Salbutamol psychosis." Biol Psychiatry 26 (1989): 631-3

34. Hall RC, Beresford TP, Stickney SK, Nasdahl CS, Coleman JH "Psychiatric reactions produced by respiratory drugs." Psychosomatics 26 (1985): 605-8,616-7

35. Ray I, Evans CJ "Paranoid psychosis with Ventolin (salbutamol tablets b.p.)." Can Psychiatr Assoc J 23 (1978): 427

36. Martin W, Unutzer J, Szuba MP "Exacerbation of psychosis associated with inhaled albuterol." J Clin Psychopharmacol 15 (1995): 446-7

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

38. Yates DH, Kharitonov SA, Barnes PJ "An inhaled glucocorticoid does not prevent tolerance to the bronchoprotective effect of a long-acting inhaled beta(2)-agonist." Am J Respir Crit Care Med 154 (1996): 1603-7

39. Sears MR, Taylor DR, Print CG, et al. "Regular inhaled beta-agonist treatment in bronchial asthma." Lancet 336 (1990): 1391-5

40. Cockcroft DW, Swystun VA "Functional antagonism: tolerance produced by inhaled beta(2) agonists." Thorax 51 (1996): 1051-6

41. Drazen JM, Israel E, Boushey HA, et al. "Comparisons of regularly scheduled with as-needed use of albuterol in mild asthma." N Engl J Med 335 (1996): 841-7

42. van Schayck CP, Dompeling E, van Herwaarden CL, et al. "Bronchodilator treatment in moderate asthma or chronic bronchitis: continuous or on demand? A randomised controlled study." BMJ 303 (1991): 1426-31

43. Raghunathan K, Nagajothi N "Paradoxical bronchospasm: a potentially life threatening adverse effect of albuterol." South Med J 99 (2006): 288-9

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