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Montelukast Side Effects

For the Consumer

Applies to montelukast: oral packet, oral tablet, oral tablet chewable

Along with its needed effects, montelukast 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 montelukast:

Less Common

  • Abdominal or stomach pain
  • bloody nose
  • flu-like symptoms
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sweating
  • tightness of the chest
  • trouble with swallowing
  • unusual tiredness or weakness

Rare

  • Pus in the urine

Incidence Not Known

  • Agitation
  • anxiety
  • attempts at killing oneself
  • breathing problems
  • confusion about identity, place, and time
  • constipation
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling sad or empty
  • hives or welts
  • indigestion
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • lack of appetite
  • pains in the stomach, side, or abdomen, possibly moving to the back
  • redness of the skin
  • shaking or trembling of the hands or feet
  • trouble with concentrating
  • unable to sleep
  • unpleasant breath odor
  • upper right abdominal or stomach pain
  • vomiting of blood
  • yellow eyes or skin

Some side effects of montelukast 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:

Less Common

  • Acid or sour stomach
  • belching
  • blurred vision
  • change in near or distance vision
  • dental pain
  • earache
  • heartburn
  • lack or loss of strength
  • pain
  • skin rash, encrusted, scaly and oozing
  • stomach discomfort, upset, or pain

Incidence Not Known

  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • dreams that are unusual
  • increased tendency to bleed
  • large, flat, blue or purplish patches on the skin
  • muscle aching or cramping
  • sleepiness
  • swollen joints

For Healthcare Professionals

Applies to montelukast: oral granule, oral tablet, oral tablet chewable

General

The most common adverse reactions (incidence more than 5% and greater than placebo) were: Upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.[Ref]

Immunologic

Very rare (less than 0.01%): Churg-Strauss Syndrome[Ref]

Churg-Strauss syndrome is a rare granulomatous eosinophilic condition that involves the upper and lower airways and manifests as rhinitis, sinusitis and asthma. If untreated the syndrome may progress to systemic vasculitis, peripheral neuropathy and potentially fatal cardiac complications. In most cases, the condition emerged during withdrawal of oral corticosteroid therapy. A causative role for leukotriene receptor antagonists has not been ruled out.[Ref]

Nervous system

Very common (10% or more): Headache (18.4%)

Common (1% to 10%): Dizziness (1.9%)

Postmarketing reports: Disturbance in attention, irritability, memory impairment, tremor, drowsiness, paraesthesia/hypoesthesia, seizures[Ref]

Dermatologic

Common (1% to 10%): Rash (1.6%), atopic dermatitis, skin infection, eczema, urticaria

Postmarketing reports: Angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain (2.9%), dyspepsia (2.1%), dental pain (1.7%), gastroenteritis (1.5%), nausea, diarrhea, dyspepsia, gastroenteritis, tooth infection[Ref]

Hepatic

Common (1% to 10%): ALT increase (2.1%), AST increased (1.6%)

Postmarketing reports: Hepatic eosinophilic infiltration; cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury. Most of these occurred in combination with other confounding factors, such as use of other medications, or when administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.[Ref]

Ocular

Common (1% to 10%): Myopia, conjunctivitis[Ref]

Other

Common (1% to 10%): Asthenia, fatigue (1.8%), fever (1.5%), trauma (1%), influenza, fever, otitis, viral infection, varicella, ear pain, otitis media

Uncommon (0.1% to 1%): Malaise

Postmarketing reports: Edema[Ref]

Respiratory

Common (1% to 10%): Influenza (4.2%), cough (2.7%), nasal congestion (1.6%), pharyngitis, sinusitis, laryngitis, infective rhinitis, acute bronchitis, rhinorrhea, pneumonia, upper respiratory infection, wheezing, tonsillitis

Postmarketing reports: Epistaxis, pulmonary eosinophilia[Ref]

Cardiovascular

Postmarketing reports: Palpitations[Ref]

Genitourinary

Postmarketing reports: Enuresis in children[Ref]

Hematologic

Postmarketing reports: Increased bleeding tendency, thrombocytopenia[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis[Ref]

Musculoskeletal

Postmarketing reports: Arthralgia, myalgia including muscle cramps[Ref]

Psychiatric

Postmarketing reports: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, restlessness, somnambulism, suicidal thinking and behavior (including suicide)[Ref]

References

1. "Product Information. Montelukast Sodium (montelukast)." Ajanta Pharma USA, Bridgewater, NJ.

2. McMorran M "Leukotriene receptor antagonists: suspected adverse reactions." Can Med Assn J 161 (1999): 868-70

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

4. "Product Information. Singulair (montelukast)." Merck & Co, Inc, West Point, PA.

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

6. De Lepeleire I, Reiss TF, Rochette F, Botto A, Zhang J, Kundu S, Decramer M "Montelukast causes prolonged, potent leukotriene D4-receptor antagonism in the airways of patients with asthma." Clin Pharmacol Ther 61 (1997): 83-92

7. Reiss TF, Chervinsky P, Dockhorn RJ, Shingo S, Seidenberg B, Edwards TB "Montelukast, a once-daily leukotriene receptor antagonist, in the treatment of chronic asthma: A multicenter, randomized, double-blind trial." Arch Intern Med 158 (1998): 1213-20

8. Bronsky EA, Kemp JP, Zhang J, Guerreiro D, Reiss TF "Dose-related protection of exercise bronchoconstriction by montelukast, a cysteinyl leukotriene-receptor antagonist, at the en of a once-daily dosing interval." Clin Pharmacol Ther 62 (1997): 556-61

9. Leff JA, Busse WW, Pearlman D, et al. "Montelukast, a leukotriene-receptor antagonist, for the treatment of mild asthma and exercise-induced bronchoconstriction." N Engl J Med 339 (1998): 147-52

10. Noonan MJ, Chervinsky P, Brandon M, Zhang J, Kundu S, McBurney J, Reiss TF "Montelukast, a potent leukotriene receptor antagonist, causes dose-related improvements in chronic asthma." Eur Respir J 11 (1998): 1232-9

11. Reiss TF, Altman LC, Chervinsky P, Bewtra A, Stricker WE, Noonan GP, Kundu S, Zhang J "Effects of montelukast (MK-0476), a new potent cysteinyl leukotriene (LTD4) receptor antagonist, in patients with chronic asthma." J Allergy Clin Immunol 98 (1996): 528-34

12. Sabio JM, Jimenez-Alonso J, Gonzalez-Crespo F "More About Churg-Strauss Syndrome and Montelukast Treatment." Chest 120 (2001): 2116

13. Minciullo PL, Saija A, Bonanno D, Ferlazzo E, Gangemi S "Montelukast-induced generalized urticaria." Ann Pharmacother 38 (2004): 999-1001

14. Sass DA, Chopra KB, Wu T "A case of montelukast-induced hepatotoxicity." Am J Gastroenterol 98 (2003): 704-5

15. Goldstein MF, Anoia J, Black M "Montelukast-induced hepatitis." Ann Intern Med 140 (2004): 586-7

16. Tang MB, Yosipovitch G "Acute churg-strauss syndrome in an asthmatic patient receiving montelukast therapy." Arch Dermatol 139 (2003): 715-8

17. Wechsler ME, Finn D, Gunawardena D, Westlake R, Barker A, Haranath SP, Pauwels RA, Kips JC, Drazen JM "Churg-Strauss syndrome in patients receiving montelukast as treatment for asthma." Chest 117 (2000): 708-13

18. Dempsey OJ "Leukotriene receptor antagonist therapy." Postgrad Med J 76 (2000): 767-73

19. Price D "Tolerability of montelukast." Drugs 59 (2000): 35-42

20. Jarvis B, Markham A "Montelukast - A review of its therapeutic potential in persistent asthma." Drugs 59 (2000): 891-928

21. Sabbagh R, Sheikh-Taha M "Possible montelukast-induced angioedema." Am J Health Syst Pharm 66 (2009): 1705-6

22. Philip G, Hustad C, Noonan G, et al. "Reports of suicidality in clinical trials of montelukast." J Allergy Clin Immunol 124 (2009): 691-696.e6

23. Kelsay K "Assessing risk: Data from montelukast clinical trials." J Allergy Clin Immunol 124 (2009): 697-8

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.

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