Singulair

Last updated on RxList: 3/4/2021
Singulair Side Effects Center

What Is Singulair?

Singulair (montelukast) is a leukotriene receptor antagonist drug used in the treatment of asthma and allergic rhinitis. Singulair is also indicated for prevention of exercise-induced narrowing of the airways.

What Are Side Effects of Singulair?

Side effects of Singulair include:

Dosage for Singulair

The following doses of Singulair are recommended: For adults and adolescents 15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet. For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules. For pediatric patients 12 to 23 months of age: one packet of 4-mg oral granules.

What Drugs, Substances, or Supplements Interact with Singulair?

Singulair may interact with phenobarbital or rifampin.

Singulair During Pregnancy and Breastfeeding

Singulair is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Singulair. It is unknown if Singulair passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Singulair Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
Singulair Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives, blisters, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a "pins and needles" feeling in your arms or legs.

Some people using montelukast have had new or worsening mental problems. Stop taking this medicine and call your doctor right away if you have unusual changes in mood or behavior, such as:

  • agitation, aggression, feeling restless or irritable;
  • anxiety, depression, confusion, problems with memory or attention;
  • stuttering, tremors, uncontrolled muscle movements;
  • suicidal thoughts or actions;
  • hallucinations, sleep problems, vivid, dreams, sleep-walking; or
  • compulsive or repetitive behaviors.

Common side effects may include:

  • stomach pain, diarrhea;
  • fever or other flu symptoms;
  • ear pain or full feeling, trouble hearing;
  • headache; or
  • cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat.

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.

Read the entire detailed patient monograph for Singulair (Montelukast Sodium)

QUESTION

Asthma is a chronic respiratory disease. See Answer
Singulair Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Neuropsychiatric Events [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment.

The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.

Adults And Adolescents 15 Years Of Age And Older With Asthma

SINGULAIR has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse reactions reported with SINGULAIR occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo:

Table 5: Adverse Reactions Occurring in ≥1% of Patients with an Incidence Greater than that in Patients Treated with Placebo

SINGULAIR
10 mg/day
(%)
(n=1955)
Placebo
(%)
(n=1180)
Body As A Whole
  Pain, abdominal2.92.5
  Asthenia/fatigue1.81.2
  Fever1.50.9
  Trauma1.00.8
Digestive System Disorders
  Dyspepsia2.11.1
  Pain, dental1.71.0
  Gastroenteritis, infectious1.50.5
Nervous System/Psychiatric
  Headache18.418.1
  Dizziness1.91.4
Respiratory System Disorders
  Influenza4.23.9
  Cough2.72.4
  Congestion, nasal1.61.3
Skin/Skin Appendages Disorder
  Rash1.61.2
Laboratory Adverse Reactions*
  ALT increased2.12.0
  AST increased1.61.2
  Pyuria1.00.9
* Number of patients tested (SINGULAIR and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159.

The frequency of less common adverse reactions was comparable between SINGULAIR and placebo.

The safety profile of SINGULAIR, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for SINGULAIR.

Cumulatively, 569 patients were treated with SINGULAIR for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse reaction profile did not significantly change.

Pediatric Patients 6 To 14 Years Of Age With Asthma

SINGULAIR has been evaluated for safety in 476 pediatric patients 6 to 14 years of age. Cumulatively, 289 pediatric patients were treated with SINGULAIR for at least 6 months, and 241 for one year or longer in clinical trials. The safety profile of SINGULAIR in the 8-week, double-blind, pediatric efficacy trial was generally similar to the adult safety profile. In pediatric patients 6 to 14 years of age receiving SINGULAIR, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: pharyngitis, influenza, fever, sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis. The frequency of less common adverse reactions was comparable between SINGULAIR and placebo. With prolonged treatment, the adverse reaction profile did not significantly change.

The safety profile of SINGULAIR, when administered as a single dose for prevention of EIB in pediatric patients 6 years of age and older, was consistent with the safety profile previously described for SINGULAIR.

In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for SINGULAIR. In a 56-week, double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving SINGULAIR, the following reactions not previously observed with the use of SINGULAIR in this age group occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia.

Pediatric Patients 2 To 5 Years Of Age With Asthma

SINGULAIR has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with SINGULAIR for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials. In pediatric patients 2 to 5 years of age receiving SINGULAIR, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: fever, cough, abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis.

Pediatric Patients 6 To 23 Months Of Age With Asthma

Safety and effectiveness in pediatric patients younger than 12 months of age with asthma have not been established.

SINGULAIR has been evaluated for safety in 175 pediatric patients 6 to 23 months of age. The safety profile of SINGULAIR in a 6-week, double-blind, placebo-controlled clinical study was generally similar to the safety profile in adults and pediatric patients 2 to 14 years of age. In pediatric patients 6 to 23 months of age receiving SINGULAIR, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: upper respiratory infection, wheezing; otitis media; pharyngitis, tonsillitis, cough; and rhinitis. The frequency of less common adverse reactions was comparable between SINGULAIR and placebo.

Adults And Adolescents 15 Years Of Age And Older With Seasonal Allergic Rhinitis

SINGULAIR has been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials. SINGULAIR administered once daily in the morning or in the evening had a safety profile similar to that of placebo. In placebo-controlled clinical trials, the following reaction was reported with SINGULAIR with a frequency ≥1% and at an incidence greater than placebo: upper respiratory infection, 1.9% of patients receiving SINGULAIR vs. 1.5% of patients receiving placebo. 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

SINGULAIR has been evaluated in 280 pediatric patients 2 to 14 years of age in a 2-week, multicenter, double-blind, placebo-controlled, parallel-group safety study. SINGULAIR administered once daily in the evening had a safety profile similar to that of placebo. In this study, the following reactions occurred with a frequency ≥2% and at an incidence greater than placebo: headache, otitis media, pharyngitis, and upper respiratory infection.

Adults And Adolescents 15 Years Of Age And Older With Perennial Allergic Rhinitis

SINGULAIR has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received SINGULAIR in two, 6-week, clinical studies. SINGULAIR administered once daily had a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, the following reactions were reported with SINGULAIR with a frequency ≥1% and at an incidence greater than placebo: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT. The incidence of somnolence was similar to that of placebo.

Pediatric Patients 6 Months To 14 Years Of Age With Perennial Allergic Rhinitis

The safety in patients 2 to 14 years of age with perennial allergic rhinitis is supported by the safety in patients 2 to 14 years of age with seasonal allergic rhinitis. The safety in patients 6 to 23 months of age is supported by data from pharmacokinetic and safety and efficacy studies in asthma in this pediatric population and from adult pharmacokinetic studies.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SINGULAIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders increased bleeding tendency, thrombocytopenia

Immune system disorders hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration

Psychiatric disorders including, but not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, and tremor [see BOXED WARNING, WARNINGS AND PRECAUTIONS]

Nervous system disorders drowsiness, paraesthesia/hypoesthesia, seizures

Cardiac disorders palpitations

Respiratory, thoracic and mediastinal disorders epistaxis, pulmonary eosinophilia

Gastrointestinal disorders diarrhea, dyspepsia, nausea, pancreatitis, vomiting

Hepatobiliary disorders Cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury have been reported in patients treated with SINGULAIR. Most of these occurred in combination with other confounding factors, such as use of other medications, or when SINGULAIR was administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.

Skin and subcutaneous tissue disorders angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria

Musculoskeletal and connective tissue disorders arthralgia, myalgia including muscle cramps

Renal and urinary disorders enuresis in children

General disorders and administration site conditions edema

Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These reactions have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Singulair (Montelukast Sodium)

© Singulair Patient Information is supplied by Cerner Multum, Inc. and Singulair Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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