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Singulair Side Effects

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Common Singulair Side Effects


The most commonly reported Singulair side effects (click to view or check a box to report):

Suicidal Ideation (1053)
Depression (1035)
Aggression (767)
Abnormal Behaviour (765)
Anxiety (739)
Allergic Granulomatous Angiitis (545)
Insomnia (439)
Anger (420)
Crying (384)
Asthma (350)
Mood Swings (346)
Nightmare (319)
Headache (315)
Mood Altered (290)
Agitation (285)
Fatigue (277)
Dyspnoea (277)
Irritability (272)
Suicide Attempt (228)
Overdose (212)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Singulair Side Effects Reported to FDA



Singulair Side Effect Report#9999671
Eosinophilic Oesophagitis
This is a report of a 9-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypersensitivity, who was treated with Singulair (dosage: 5 Mg, Qd, start time:
Dec 04, 2013), combined with:
  • Zyrtec
  • Nexium
  • Benadryl
and developed a serious reaction and side effect(s): Eosinophilic Oesophagitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair treatment in male patients, resulting in Eosinophilic Oesophagitis side effect.
Singulair Side Effect Report#9999169
Insomnia, Anxiety, Depression, Panic Attack, Anger, Crying, Weight Increased, Social Phobia, Apathy
This report suggests a potential Singulair Insomnia side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: seasonal allergy,asthma and used Singulair (dosage: Taken By Mouth) starting
Jan 01, 2012. After starting Singulair the patient began experiencing various side effects, including: Insomnia, Anxiety, Depression, Panic Attack, Anger, Crying, Weight Increased, Social Phobia, ApathyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Insomnia, may still occur.
Singulair Side Effect Report#9999038
Pruritus, Hallucination, Visual, Erythema, Pain In Extremity, Oedema Peripheral, Headache, Crying, Fear, Conversion Disorder
This Pruritus problem was reported by a health professional from US. A 8-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: asthma. On
Mar 03, 2014 this consumer started treatment with Singulair (dosage: 1 Chewable Tablet Qd Oral). The following drugs were being taken at the same time: NA. When using Singulair, the patient experienced the following unwanted symptoms/side effects: Pruritus, Hallucination, Visual, Erythema, Pain In Extremity, Oedema Peripheral, Headache, Crying, Fear, Conversion DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pruritus, may become evident only after a product is in use by the general population.
Singulair Side Effect Report#9998912
Dyspnoea, Overdose
This Dyspnoea side effect was reported by a consumer or non-health professional from US. A 14-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Singulair (drug dosage: 5 Mg Daily), which was initiated on
Feb 21, 2014. Concurrently used drugs: NA..After starting to take Singulair the consumer reported adverse symptoms, such as: Dyspnoea, OverdoseThese side effects may potentially be related to Singulair.
Singulair Side Effect Report#9998317
Adverse Event, Blood Urea Increased
This is a report of a 10-year-old patient (weight: NA) from JP, suffering from the following health symptoms/conditions: NA, who was treated with Singulair Chewable Tablets 5mg (dosage: NA, start time: NS), combined with:
  • Adoair
and developed a serious reaction and side effect(s): Adverse Event, Blood Urea Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair Chewable Tablets 5mg treatment in patients, resulting in Adverse Event side effect. The patient was hospitalized.
Singulair Side Effect Report#9998294
Completed Suicide, Poisoning
This report suggests a potential Singulair Completed Suicide side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Singulair (dosage: Unk) starting NS. After starting Singulair the patient began experiencing various side effects, including: Completed Suicide, PoisoningAdditional drugs used concurrently:
  • Phenobarbital (Unk)
  • Diazepam (Unk)
  • Topiramate (Unk)
  • Gabapentin (Unk)
  • Temazepam
  • Clonazepam
  • Naproxen (Unk)
  • Progestin (Unk)
Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Singulair Side Effect Report#9992615
Abnormal Behaviour, Sleep Disorder, Aggression, Affect Lability
This Abnormal Behaviour problem was reported by a health professional from AU. A 8-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 09, 2014 this consumer started treatment with Singulair (dosage: Daily). The following drugs were being taken at the same time: NA. When using Singulair, the patient experienced the following unwanted symptoms/side effects: Abnormal Behaviour, Sleep Disorder, Aggression, Affect LabilityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abnormal Behaviour, may become evident only after a product is in use by the general population.
Singulair Side Effect Report#9988608
Toxicity To Various Agents, Hypotension, Poisoning, Intentional Overdose, Overdose
This Death side effect was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Singulair (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Vytorin
  • Prinivil
  • Lisinopril
  • Pravastatin Sodium
  • Tagamet Hb
  • Naproxen
  • Gabapentin
  • Hydrocodone
.After starting to take Singulair the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Hypotension, Poisoning, Intentional Overdose, OverdoseThese side effects may potentially be related to Singulair. The patient was hospitalized.
Singulair Side Effect Report#9984600
Rectal Haemorrhage, Back Pain, Dyspnoea, Dizziness, Heart Rate Increased, Lung Neoplasm, Loss Of Consciousness, Heart Rate Increased
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: asthma,dyspnoea, who was treated with Singulair (dosage: Unk, start time: 1993), combined with:
  • Proventil (2 Puffs, Qd)
  • Azmacort (Unk)
  • Serevent (Unk)
  • Serevent
and developed a serious reaction and side effect(s): Rectal Haemorrhage, Back Pain, Dyspnoea, Dizziness, Heart Rate Increased, Lung Neoplasm, Loss Of Consciousness, Heart Rate Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair treatment in female patients, resulting in Sudden Death side effect.
Singulair Side Effect Report#9981142
Asthma, Sleep Disorder, Aggression, Insomnia, Irritability
This report suggests a potential Singulair Asthma side effect(s) that can have serious consequences. A 4-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: asthma and used Singulair (dosage: 4 Mg, Unk) starting 2012. After starting Singulair the patient began experiencing various side effects, including: Asthma, Sleep Disorder, Aggression, Insomnia, IrritabilityAdditional drugs used concurrently:
  • Flovent (Unk, Bid)
  • Ventolin (albuterol Sulfate) (Unk, Prn)
The patient was hospitalized. Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthma, may still occur.
Singulair Side Effect Report#9980676
Abnormal Dreams
This Abnormal Dreams problem was reported by a consumer or non-health professional from US. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypersensitivity. On 201311 this consumer started treatment with Singulair (dosage: 10 Mg, Qd). The following drugs were being taken at the same time:
  • Allegra
  • Claritin
When using Singulair, the patient experienced the following unwanted symptoms/side effects: Abnormal DreamsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abnormal Dreams, may become evident only after a product is in use by the general population.
Singulair Side Effect Report#9972865
Poisoning Deliberate, Respiratory Arrest, Cardiac Arrest, Completed Suicide, Overdose
This Poisoning Deliberate side effect was reported by a health professional from US. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Singulair (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Diltiazem Hydrochloride
  • Cocaine
  • Alcohol
.After starting to take Singulair the consumer reported adverse symptoms, such as: Poisoning Deliberate, Respiratory Arrest, Cardiac Arrest, Completed Suicide, OverdoseThese side effects may potentially be related to Singulair.
Singulair Side Effect Report#9935231
Femur Fracture, Internal Fixation Of Fracture, Fall, Pneumonia, Malaise, Back Pain
This is a report of a 57-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: asthma, who was treated with Singulair (dosage: 10 Mg Daily Dose, start time:
Sep 30, 2013), combined with: NA. and developed a serious reaction and side effect(s): Femur Fracture, Internal Fixation Of Fracture, Fall, Pneumonia, Malaise, Back Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair treatment in female patients, resulting in Femur Fracture side effect. The patient was hospitalized.
Singulair Side Effect Report#9934211
Hospitalisation
This report suggests a potential Singulair Hospitalisation side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: asthma and used Singulair (dosage: 10 Mg, Qd) starting
Nov 12, 2013. After starting Singulair the patient began experiencing various side effects, including: HospitalisationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hospitalisation, may still occur.
Singulair Side Effect Report#9931328
Rash, Pruritus
This Rash problem was reported by a consumer or non-health professional from US. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: dermatitis allergic,pruritus,chronic obstructive pulmonary disease. On
Feb 04, 2014 this consumer started treatment with Singulair (dosage: Unk). The following drugs were being taken at the same time: NA. When using Singulair, the patient experienced the following unwanted symptoms/side effects: Rash, PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash, may become evident only after a product is in use by the general population.
Singulair Side Effect Report#9931131
Confusional State, Intentional Self-injury, Social Avoidant Behaviour, Depression, Feeling Abnormal, Hallucination, Nightmare, Abdominal Pain Upper
This Confusional State side effect was reported by a consumer or non-health professional from GB. A 25-year-old female patient (weight:NA) experienced the following symptoms/conditions: rhinitis allergic,asthma.The patient was prescribed Singulair (drug dosage: 1 Df, Qd), which was initiated on
Sep 01, 2010. Concurrently used drugs: NA..After starting to take Singulair the consumer reported adverse symptoms, such as: Confusional State, Intentional Self-injury, Social Avoidant Behaviour, Depression, Feeling Abnormal, Hallucination, Nightmare, Abdominal Pain UpperThese side effects may potentially be related to Singulair.
Singulair Side Effect Report#9925118
Nightmare, Insomnia, Middle Insomnia, Stress, Agitation, Screaming, Social Avoidant Behaviour, Confusional State, Hallucination
This is a report of a 4-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: hypersensitivity, who was treated with Singulair (dosage: 1 Once Daily, start time:
Oct 14, 2012), combined with: NA. and developed a serious reaction and side effect(s): Nightmare, Insomnia, Middle Insomnia, Stress, Agitation, Screaming, Social Avoidant Behaviour, Confusional State, Hallucination after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair treatment in female patients, resulting in Nightmare side effect. The patient was hospitalized.
Singulair Side Effect Report#9925103
Aggression, Feeling Abnormal, Nervousness, Paranoia
This report suggests a potential Singulair Aggression side effect(s) that can have serious consequences. A 6-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: asthma and used Singulair (dosage: NA) starting
Jan 20, 2014. After starting Singulair the patient began experiencing various side effects, including: Aggression, Feeling Abnormal, Nervousness, ParanoiaAdditional drugs used concurrently: NA. Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aggression, may still occur.
Singulair Side Effect Report#9917603
Ileus Paralytic, Prescribed Overdose
This Ileus Paralytic problem was reported by a consumer or non-health professional from JP. A 8-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Singulair Tablets 10mg (dosage: 10 Mg, Qd). The following drugs were being taken at the same time: NA. When using Singulair Tablets 10mg, the patient experienced the following unwanted symptoms/side effects: Ileus Paralytic, Prescribed OverdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ileus Paralytic, may become evident only after a product is in use by the general population.
Singulair Side Effect Report#9912906
Depression, Anxiety, Depressed Mood, Crying
This Depression side effect was reported by a consumer or non-health professional from US. A 5-year-old male patient (weight:NA) experienced the following symptoms/conditions: allergic cough.The patient was prescribed Singulair (drug dosage: NA), which was initiated on
Jun 01, 2013. Concurrently used drugs: NA..After starting to take Singulair the consumer reported adverse symptoms, such as: Depression, Anxiety, Depressed Mood, CryingThese side effects may potentially be related to Singulair.
Singulair Side Effect Report#9896881
Rib Fracture, Sneezing, Rib Fracture
This is a report of a 42-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Singulair (dosage: 10 Mg, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Rib Fracture, Sneezing, Rib Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair treatment in female patients, resulting in Rib Fracture side effect.
Singulair Side Effect Report#9890550
Suicide Attempt, Depression
This report suggests a potential Singulair Suicide Attempt side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: asthma and used Singulair (dosage: 10 Mg, Unk) starting
Jan 10, 2013. After starting Singulair the patient began experiencing various side effects, including: Suicide Attempt, DepressionAdditional drugs used concurrently: NA. Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicide Attempt, may still occur.
Singulair Side Effect Report#9883796
Aggression, Autism, Personality Change, Suicidal Ideation
This Aggression problem was reported by a consumer or non-health professional from GB. A 6-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: asthma. On
Jun 01, 2011 this consumer started treatment with Singulair (dosage: 5 Mg, Unk). The following drugs were being taken at the same time:
  • Clenil Modulite
  • Loratadine
  • Salamol
  • Salmeterol
When using Singulair, the patient experienced the following unwanted symptoms/side effects: Aggression, Autism, Personality Change, Suicidal IdeationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Aggression, may become evident only after a product is in use by the general population.
Singulair Side Effect Report#9883754
Overdose
This Overdose side effect was reported by a physician from US. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: dermatitis atopic.The patient was prescribed Singulair (drug dosage: 10 Mg, Qd), which was initiated on 200804. Concurrently used drugs: NA..After starting to take Singulair the consumer reported adverse symptoms, such as: OverdoseThese side effects may potentially be related to Singulair.
Singulair Side Effect Report#9878772
Sinusitis, Incorrect Dose Administered
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: sinusitis, who was treated with Singulair (dosage: 5 Mg, Unk, start time: 200901), combined with: NA. and developed a serious reaction and side effect(s): Sinusitis, Incorrect Dose Administered after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Singulair treatment in female patients, resulting in Sinusitis side effect.


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The appearance of Singulair on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


What are common Singulair Side Effects for Women?

Women Side EffectsReports
Depression 564
Suicidal Ideation 497
Anxiety 389
Allergic Granulomatous Angiitis 320
Abnormal Behaviour 278
Aggression 252
Insomnia 224
Asthma 216
Dyspnoea 205
Headache 190

What are common Singulair Side Effects for Men?

Men Side EffectsReports
Suicidal Ideation 545
Aggression 506
Abnormal Behaviour 483
Depression 454
Anxiety 345
Anger 265
Allergic Granulomatous Angiitis 222
Insomnia 214
Crying 200
Mood Swings 190

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Singulair reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Singulair Side Effects

    Did You Have a Singulair Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Singulair for You?

    Exceeded Expectations
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    Singulair Safety Alerts, Active Ingredients, Usage Information

    NDC0006-0275
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSINGULAIR
    Namemontelukast sodium
    Dosage FormTABLET, CHEWABLE
    RouteORAL
    On market since19980220
    LabelerMerck Sharp & Dohme Corp.
    Active Ingredient(s)MONTELUKAST SODIUM
    Strength(s)5
    Unit(s)mg/1
    Pharma ClassLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

    Singulair Dosage, Warnings, Usage.

    Side Effects reported to FDA: 7525

    Singulair safety alerts: 2009 2008

    Reported deaths: 333

    Reported hospitalizations: 2362

    Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

    Audience: Pulmonology healthcare professionals

    [UPDATED 08/28/2009] The June 12, 2009 Healthcare Professional Sheet has been updated.

    FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communication about the ongoing safety review for the leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. FDA recommends that:

    • Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
    • Patients should talk with their healthcare providers if these events occur.
    • Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

     

    [06/12/2009, Updated 08/28/2009 - Healthcare Professional Sheet - FDA]

    Previous MedWatch Alert:

    [03/27/2008 - Singulair (montelukast)]

     

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