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Singulair Side Effects

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.

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.

Singulair Side Effects Reported to FDA

The following 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.


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.
Eosinophilic Oesophagitis
This is a report of a 9-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Eosinophilic Oesophagitis
which developed 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.

Insomnia, Anxiety, Depression, Panic Attack, Anger, Crying, Weight Increased, Social Phobia, Apathy
This report suggests a potential Singulair Insomnia, Anxiety, Depression, Panic Attack, Anger, Crying, Weight Increased, Social Phobia, Apathy 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. Soon after starting Singulair the patient began experiencing various side effects, including:
  • Insomnia
  • Anxiety
  • Depression
  • Panic Attack
  • Anger
  • Crying
  • Weight Increased
  • Social Phobia
  • Apathy
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.

Pruritus, Hallucination, Visual, Erythema, Pain In Extremity, Oedema Peripheral, Headache, Crying, Fear, Conversion Disorder
This Pruritus, Hallucination, Visual, Erythema, Pain In Extremity, Oedema Peripheral, Headache, Crying, Fear, Conversion Disorder 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 commencing Singulair, the patient experienced the following unwanted symptoms/side effects:
  • Pruritus
  • Hallucination, Visual
  • Erythema
  • Pain In Extremity
  • Oedema Peripheral
  • Headache
  • Crying
  • Fear
  • Conversion Disorder
Although 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.

Dyspnoea, Overdose
This is a report of a 14-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Singulair (dosage: 5 Mg Daily) starting Feb 21, 2014. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Dyspnoea
  • Overdose
This opens a possibility that Singulair treatment could cause the above reactions, including dyspnoea, and some male subjects may be more susceptible.


Adverse Event, Blood Urea Increased
A 10-year-old patient (weight: NA) from JP with the following symptoms/conditions: NA started Singulair Chewable Tablets 5mg treatment (dosage: NA) on NS. Soon after starting Singulair Chewable Tablets 5mg treatment, the subject experienced various side effects, including:
  • Adverse Event
  • Blood Urea Increased
Concurrently used drugs:
  • Adoair
The patient was hospitalized. This finding indicates that some patients could be more vulnerable to Singulair Chewable Tablets 5mg.

Completed Suicide, Poisoning
A 45-year-old female patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Singulair(dosage: Unk). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Completed Suicide
  • Poisoning
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Singulair efficacy:
  • Phenobarbital (Unk)
  • Diazepam (Unk)
  • Topiramate (Unk)
  • Gabapentin (Unk)
  • Temazepam
  • Clonazepam
  • Naproxen (Unk)
  • Progestin (Unk)


Abnormal Behaviour, Sleep Disorder, Aggression, Affect Lability
In this report, Singulair was administered for the following condition: NA.A 8-year-old female consumer from AU (weight: NA) started Singulair treatment (dosage: Daily) on Jan 09, 2014.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Abnormal Behaviour
  • Sleep Disorder
  • Aggression
  • Affect Lability
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Singulair treatment could be related to the listed above side effect(s).

Toxicity To Various Agents, Hypotension, Poisoning, Intentional Overdose
This is a report of the following Singulair side effect(s):
  • Toxicity To Various Agents
  • Hypotension
  • Poisoning
  • Intentional Overdose
A 55-year-old female patient from US (weight: NA) presented with the following condition: NA and received a treatment with Singulair (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Vytorin
  • Prinivil
  • Lisinopril
  • Pravastatin Sodium
  • Tagamet Hb
  • Naproxen
  • Gabapentin
  • Hydrocodone
The patient was hospitalized.This report suggests that a Singulair treatment could be associated with the listed above side effect(s).

Rectal Haemorrhage, Back Pain, Dyspnoea, Dizziness, Heart Rate Increased, Lung Neoplasm, Loss Of Consciousness
This Singulair report was submitted by a female consumer from US (weight: NA). The patient was diagnosed with: asthma,dyspnoea and Singulair was administered (dosage: Unk) starting: 1993. The consumer developed a set of symptoms:
  • Rectal Haemorrhage
  • Back Pain
  • Dyspnoea
  • Dizziness
  • Heart Rate Increased
  • Lung Neoplasm
  • Loss Of Consciousness
Other drugs used simultaneously:
  • Proventil (2 Puffs, Qd)
  • Azmacort (Unk)
  • Serevent (Unk)
  • Serevent
Those unexpected symptoms could be linked to a Singulair treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Asthma, Sleep Disorder, Aggression, Insomnia, Irritability
This is a report of a possible correlation between Singulair use and the following symptoms/side effect(s):
  • Asthma
  • Sleep Disorder
  • Aggression
  • Insomnia
  • Irritability
which could contribute to an assessment of Singulair risk profile.A 4-year-old male consumer from CA (weight: NA) was suffering from asthma and was treated with Singulair (dosage: 4 Mg, Unk) starting 2012.Other concurrent medications:
  • Flovent (Unk, Bid)
  • Ventolin (albuterol Sulfate) (Unk, Prn)
The patient was hospitalized.

Abnormal Dreams
A 54-year-old female patient from US (weight: NA) presented with the following symptoms: hypersensitivity and after a treatment with Singulair (dosage: 10 Mg, Qd) experienced the following side effect(s):
  • Abnormal Dreams
The treatment was started on 201311. Singulair was used in combination with the following drugs:
  • Allegra
  • Claritin
This report could alert potential Singulair consumers.

Poisoning Deliberate, Respiratory Arrest, Cardiac Arrest, Completed Suicide, Overdose
In this report, a 47-year-old male patient from US (weight: NA) was affected by a possible Singulair side effect.The patient was diagnosed with NA. After a treatment with Singulair (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Poisoning Deliberate
  • Respiratory Arrest
  • Cardiac Arrest
  • Completed Suicide
  • Overdose
The following simultaneously used drugs could have led to this reaction:
  • Diltiazem Hydrochloride
  • Cocaine
  • Alcohol
The findings here stress that side effects should be taken into consideration when evaluating a Singulair treatment.

Femur Fracture, Internal Fixation Of Fracture, Fall, Pneumonia, Malaise, Back Pain
This is a report of a 57-year-old female patient from CA (weight: NA), who used Singulair (dosage: 10 Mg Daily Dose) for a treatment of asthma. After starting a treatment on Sep 30, 2013, the patient experienced the following side effect(s):
  • Femur Fracture
  • Internal Fixation Of Fracture
  • Fall
  • Pneumonia
  • Malaise
  • Back Pain
The following drugs could possibly have interacted with the Singulair treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Singulair treatment could be related to side effect(s), such as Femur Fracture, Internal Fixation Of Fracture, Fall, Pneumonia, Malaise, Back Pain.

Hospitalisation
This hospitalisation side effect was reported by a consumer or non-health professional from CA. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: asthma. The patient was prescribed Singulair (dosage: 10 Mg, Qd), which was started on Nov 12, 2013. Concurrently used drugs: NA. When starting to take Singulair the consumer reported the following symptoms:
  • Hospitalisation
The patient was hospitalized. These side effects may potentially be related to Singulair.

Rash, Pruritus
This is a Singulair side effect report of a 58-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: dermatitis allergic,pruritus,chronic obstructive pulmonary disease, who was treated with Singulair (dosage:Unk, start time: Feb 04, 2014), combined with: NA., and developed a serious reaction and a rash side effect. The patient presented with:
  • Rash
  • Pruritus
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Singulair treatment in male patients suffering from dermatitis allergic,pruritus,chronic obstructive pulmonary disease, resulting in rash.

Confusional State, Intentional Self-injury, Social Avoidant Behaviour, Depression, Feeling Abnormal, Hallucination, Nightmare, Abdominal Pain Upper
This report suggests a potential Singulair confusional state side effect(s) that can have serious consequences. A 25-year-old female patient from GB (weight:NA) was diagnosed with the following health condition(s): rhinitis allergic,asthma and used Singulair (dosage: 1 Df, Qd) starting Sep 01, 2010. Soon after starting Singulair the patient began experiencing various side effects, including:
  • Confusional State
  • Intentional Self-injury
  • Social Avoidant Behaviour
  • Depression
  • Feeling Abnormal
  • Hallucination
  • Nightmare
  • Abdominal Pain Upper
Drugs used concurrently:NA. Although Singulair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as confusional state, may still occur.

Nightmare, Insomnia, Middle Insomnia, Stress, Agitation, Screaming, Social Avoidant Behaviour, Confusional State, Hallucination
This nightmare problem was reported by a consumer or non-health professional from US. A 4-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): hypersensitivity.On Oct 14, 2012 a consumer started treatment with Singulair (dosage: 1 Once Daily). The following drugs/medications were being taken at the same time: NA. When commencing Singulair, the patient experienced the following unwanted symptoms /side effects:
  • Nightmare
  • Insomnia
  • Middle Insomnia
  • Stress
  • Agitation
  • Screaming
  • Social Avoidant Behaviour
  • Confusional State
  • Hallucination
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as nightmare, may become evident only after a product is in use by the general population.

Aggression, Feeling Abnormal, Nervousness, Paranoia
This is a Singulair side effect report of a 6-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: asthma and was treated with Singulair (dosage: NA) starting Jan 20, 2014. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Aggression
  • Feeling Abnormal
  • Nervousness
  • Paranoia
This opens a possibility that Singulair could cause aggression and that some female patients may be more susceptible.

Ileus Paralytic, Prescribed Overdose
A 8-year-old male patient (weight: NA) from JP with the following symptoms: NA started Singulair Tablets 10mg treatment (dosage: 10 Mg, Qd) on NS. Soon after starting Singulair Tablets 10mg treatment, the consumer experienced several side effects, including:
  • Ileus Paralytic
  • Prescribed Overdose
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Singulair Tablets 10mg side effects, such as ileus paralytic.

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 (dosage: NA), which was started on Jun 01, 2013. Concurrently used drugs: NA..When starting to take Singulair the consumer reported symptoms, such as:
  • Depression
  • Anxiety
  • Depressed Mood
  • Crying
These side effects may potentially be related to Singulair.

Rib Fracture, Sneezing
This is a report of a 42-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Rib Fracture
  • Sneezing
which developed 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.

Suicide Attempt, Depression
This report suggests a potential Singulair Suicide Attempt, Depression 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. Soon after starting Singulair the patient began experiencing various side effects, including:
  • Suicide Attempt
  • Depression
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.

Aggression, Autism, Personality Change, Suicidal Ideation
This Aggression, Autism, Personality Change, Suicidal Ideation 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 commencing Singulair, the patient experienced the following unwanted symptoms/side effects:
  • Aggression
  • Autism
  • Personality Change
  • Suicidal Ideation
Although 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.

Overdose
This is a report of a 46-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: dermatitis atopic and was treated with Singulair (dosage: 10 Mg, Qd) starting 200804. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Overdose
This opens a possibility that Singulair treatment could cause the above reactions, including overdose, and some female subjects may be more susceptible.

Sinusitis, Incorrect Dose Administered
A 57-year-old female patient (weight: NA) from US with the following symptoms/conditions: sinusitis started Singulair treatment (dosage: 5 Mg, Unk) on 200901. Soon after starting Singulair treatment, the subject experienced various side effects, including:
  • Sinusitis
  • Incorrect Dose Administered
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Singulair.

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Top 10 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

Top 10 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

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Singulair Side Effects

    Did You Have a Singulair Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Singulair for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    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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