What are the possible side effects of Montelukast?
Get emergency medical help if you have signs of an allergic reaction to Montelukast: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
unusual changes in mood or behavior;
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
ear pain, swelling, or warmth; or
severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Montelukast side effects may include:
stomach pain, diarrhea;
fever or other flu symptoms;
cold symptoms such as stuffy nose, sinus pain, cough, sore throat;
headache; or
bed-wetting or loss of bladder control in children.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Montelukast in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Montelukast has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy. The overall incidence of side effects reported with Montelukast was comparable to placebo.
Adults 15 Years of Age and Older with Asthma: Montelukast has been evaluated in approximately 2600 adult patients 15 years of age and older in clinical studies. In two similarly designed, 12-week placebo-controlled clinical studies, the only adverse experiences reported as drug related in ≥ 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were abdominal pain and headache. The incidences of these events were not significantly different in the two treatment groups.
Cumulatively, 544 patients were treated with Montelukast for at least 6 months, 253 for one year and 21 for 2 years in clinical studies. With prolonged treatment, the adverse experience profile did not change.
Pediatric Patients 6 to 14 Years of Age with Asthma: Montelukast has been evaluated in approximately 475 pediatric patients 6 to 14 years of age. The safety profile in pediatric patients is generally similar to the adult safety profile and to placebo.
In an 8-week, placebo-controlled clinical study, the only adverse experience reported as drug related in > 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo was headache. The incidence of headache was not significantly different in the two treatment groups.
In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for Montelukast.
Cumulatively, 263 pediatric patients 6 to 14 years of age were treated with Montelukast for at least 3 months and 164 for 6 months or longer. With prolonged treatment, the adverse experience profile did not change.
Pediatric Patients 2 to 5 Years of Age with Asthma: Montelukast has been evaluated in 573 pediatric patients 2 to 5 years of age. In a 12-week, placebo-controlled clinical study, the only adverse experience reported as drug related in > 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo was thirst. The incidence of thirst was not significantly different in the two treatment groups.
Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with Montelukast for at least 3 months, 230 for 6 months or longer, and 63 patients for 12 months or longer. With prolonged treatment, the adverse experience profile did not change.
Pediatric Patients 6 Months to 2 Years of Age with Asthma: Montelukast has been evaluated in 175 pediatric patients 6 months to 2 years of age. In a 6-week, placebo-controlled clinical study, the adverse experiences reported as drug related in > 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were diarrhea, hyperkinesia, asthma, eczematous dermatitis and rash.
The incidences of these adverse experiences were not significantly different in the two treatment groups.
Adults 15 Years of Age and Older with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 2199 adult patients 15 years of age and older for the treatment of seasonal allergic rhinitis in clinical studies. Montelukast administered once daily in the morning or in the evening was generally well tolerated with a safety profile similar to that of placebo. In placebo-controlled clinical studies, no adverse experiences reported as drug related in 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were observed. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies.
Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis: Montelukast has been evaluated in 280 pediatric patients 2 to 14 years of age for the treatment of seasonal allergic rhinitis in a 2-week, placebo-controlled, clinical study. Montelukast administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. In this study, no adverse experiences reported as drug related in 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were observed.
Adults 15 Years of Age and Older with Perennial Allergic Rhinitis: Montelukast has been evaluated in 3235 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis in two, 6-week, placebo-controlled, clinical studies.
Montelukast administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, no adverse experiences reported as drug related in 1% of patients treated with Montelukast and at a greater incidence than in patients treated with placebo were observed. The incidence of somnolence was similar to that of placebo.
Pooled Analyses of Clinical Trials Experience: A pooled analysis of 41 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 6 studies in pediatric patients 6 to 14 years of age) was performed using a validated assessment method of suicidality. Among the 9929 patients who received Montelukast and 7780 patients who received placebo in these studies, there was one patient with suicidal ideation in the group taking Montelukast. There were no completed suicides, suicide attempts or preparatory acts toward suicidal behavior in either treatment group.
A separate pooled analysis of 46 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 11 studies in pediatric patients 3 months to 14 years of age) assessing behavior-related adverse experiences (BRAEs) was performed. Among the 11,673 patients who received Montelukast and 8827 patients who received placebo in these studies, the frequency of patients with at least one BRAE was 2.73% in patients who received Montelukast and 2.27% in patients who received placebo; the odds ratio was 1.12 [95% CI (0.93; 1.36)].
The clinical trials included in these pooled analyses were not designed specifically to examine suicidality or BRAEs.
Postmarketing Experience: The following side effects have been reported in postmarketing use: Infections and Infestations: Upper respiratory infection.
Blood and Lymphatic System Disorders: Increased bleeding tendency.
Immune System Disorders: Hypersensitivity reactions including anaphylaxis, very rarely hepatic eosinophilic infiltration.
Psychiatric Disorders: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, memory impairment, psychomotor hyperactivity (including irritability, restlessness, and tremor) somnambulism, suicidal thinking and behavior (suicidality).
Nervous System Disorders: Dizziness, drowsiness, paraesthesia/hypoesthesia, very rarely seizure.
Cardiac Disorders: Palpitations.
Respiratory, Thoracic and Mediastinal Disorders: Epistaxis.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia including muscle cramps.
Renal and Urinary Disorders: Enuresis in children.
General Disorders and Administration Site Conditions: Asthenia/fatigue, edema, pyrexia.
What is the most important information I should know about Montelukast?
Montelukast chewable tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Montelukast chewable tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Montelukast chewable tablets will not stop an asthma attack once one has started. Be sure you always carry appropriate medicine (eg, bronchodilator inhalers) with you in case of an asthma attack.
Contact your doctor promptly if your short-acting inhaler use increases or if use exceeds the 24-hour maximum prescribed by your doctor. Contact your doctor if your asthma worsens.
Do not decrease your dose or stop using Montelukast chewable tablets or other asthma medicines without first checking with your doctor.
If your asthma is sensitive to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), continue to avoid those medicines as directed by your doctor.
Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
Some patients taking Montelukast chewable tablets have developed mental or mood changes, including suicidal thoughts or actions. Contact your doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact your doctor immediately if any signs of suicidal thoughts or actions occur.
Tell your doctor or dentist that you take Montelukast chewable tablets before you receive any medical or dental care, emergency care, or surgery.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Montelukast chewable tablets while you are pregnant. It is not known if Montelukast chewable tablets is found in breast milk. If you are or will be breast-feeding while you use Montelukast chewable tablets, check with your doctor. Discuss any possible risks to your baby.
Montelukast contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Hypersensitivity to Montelukast sodium or to any of the excipients of Montelukast.
Use in children: Montelukast should not be used in children <15 years due to high content of Montelukast. Other dosage forms with appropriate strengths are available for younger children.
References
European Chemicals Agency - ECHA. "Cyclopropaneacetic acid, 1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Montelukast are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Montelukast. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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