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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
on Mar 12, 2014 Male from US , child 9 years of age, was diagnosed with and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: eosinophilic oesophagitis. Singulair dosage: 5 Mg, Qd.
Associated medications used:
  • Zyrtec
  • Nexium
  • Benadryl


Insomnia, Anxiety, Depression, Panic Attack, Anger, Crying, Weight Increased, Social Phobia, Apathy
Patient was taking Singulair. Patient felt the following Singulair side effects: insomnia, anxiety, depression, panic attack, anger, crying, weight increased, social phobia, apathy on Mar 11, 2014 from US Additional patient health information: Female , 32 years of age, weighting 134.0 lb, was diagnosed with and. Singulair dosage: Taken By Mouth. Patient was hospitalized.

Pruritus, Hallucination, Visual, Erythema, Pain In Extremity, Oedema Peripheral, Headache, Crying, Fear, Conversion Disorder
Adverse event was reported on Mar 11, 2014 by a Female taking Singulair (Dosage: 1 Chewable Tablet Qd Oral) was diagnosed with and. Location: US , child 8 years of age, weighting 53.99 lb, After Singulair was administered, patient encountered several Singulair side effects: pruritus, hallucination, visual, erythema, pain in extremity, oedema peripheral, headache, crying, fear, conversion disorder.

Dyspnoea, Overdose
on Mar 12, 2014 Male from US , 14 years of age, was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: dyspnoea, overdose. Singulair dosage: 5 Mg Daily.


Adverse Event, Blood Urea Increased
on Mar 12, 2014 Patient from JP , child 10 years of age, was treated with Singulair Chewable Tablets 5mg. Patient felt the following Singulair side effects: adverse event, blood urea increased. Singulair Chewable Tablets 5mg dosage: N/A.
Multiple prescriptions taken:
  • Adoair
Patient was hospitalized.

Completed Suicide, Poisoning
Patient was taking Singulair. After Singulair was administered, patient encountered several Singulair side effects: completed suicide, poisoning on Mar 12, 2014 from US Additional patient health information: Female , 45 years of age, . Singulair dosage: Unk.
Multiple concurrent drugs taken:
  • Phenobarbital (Unk)
  • Diazepam (Unk)
  • Topiramate (Unk)
  • Gabapentin (Unk)
  • Temazepam
  • Clonazepam
  • Naproxen (Unk)
  • Progestin (Unk)


Abnormal Behaviour, Sleep Disorder, Aggression, Affect Lability
Adverse event was reported on Mar 10, 2014 by a Female taking Singulair (Dosage: Daily) . Location: AU , child 8 years of age, Directly after, patient experienced the unwanted or unexpected Singulair side effects: abnormal behaviour, sleep disorder, aggression, affect lability.

Toxicity To Various Agents, Hypotension, Poisoning, Intentional Overdose
on Mar 17, 2014 Female from US , 55 years of age, was treated with Singulair. Patient felt the following Singulair side effects: toxicity to various agents, hypotension, poisoning, intentional overdose. Singulair dosage: N/A.
Multiple prescriptions taken:
  • Vytorin
  • Prinivil
  • Lisinopril
  • Pravastatin Sodium
  • Tagamet Hb
  • Naproxen
  • Gabapentin
  • Hydrocodone
Patient was hospitalized.

Rectal Haemorrhage, Back Pain, Dyspnoea, Dizziness, Heart Rate Increased, Lung Neoplasm, Loss Of Consciousness
on Mar 07, 2014 Female from US , weighting 98.00 lb, was diagnosed with and was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: rectal haemorrhage, back pain, dyspnoea, dizziness, heart rate increased, lung neoplasm, loss of consciousness. Singulair dosage: Unk.
Multiple concurrent drugs taken:
  • Proventil (2 Puffs, Qd)
  • Azmacort (Unk)
  • Serevent (Unk)
  • Serevent


Asthma, Sleep Disorder, Aggression, Insomnia, Irritability
Patient was taking Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: asthma, sleep disorder, aggression, insomnia, irritability on Mar 07, 2014 from CA Additional patient health information: Male , child 4 years of age, was diagnosed with and. Singulair dosage: 4 Mg, Unk.
Associated medications used:
  • Flovent (Unk, Bid)
  • Ventolin (albuterol Sulfate) (Unk, Prn)
Patient was hospitalized.

Abnormal Dreams
Adverse event was reported on Mar 07, 2014 by a Female taking Singulair (Dosage: 10 Mg, Qd) was diagnosed with and. Location: US , 54 years of age, Patient felt the following Singulair side effects: abnormal dreams.
Multiple prescriptions taken:
  • Allegra
  • Claritin


Poisoning Deliberate, Respiratory Arrest, Cardiac Arrest, Completed Suicide, Overdose
on Mar 06, 2014 Male from US , 47 years of age, was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: poisoning deliberate, respiratory arrest, cardiac arrest, completed suicide, overdose. Singulair dosage: N/A.
Multiple concurrent drugs taken:
  • Diltiazem Hydrochloride
  • Cocaine
  • Alcohol


Femur Fracture, Internal Fixation Of Fracture, Fall, Pneumonia, Malaise, Back Pain
on Mar 24, 2014 Female from CA , 57 years of age, was diagnosed with and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: femur fracture, internal fixation of fracture, fall, pneumonia, malaise, back pain. Singulair dosage: 10 Mg Daily Dose. Patient was hospitalized.

Hospitalisation
Patient was taking Singulair. Patient felt the following Singulair side effects: hospitalisation on Feb 28, 2014 from CA Additional patient health information: Female , 74 years of age, was diagnosed with and. Singulair dosage: 10 Mg, Qd. Patient was hospitalized.

Rash, Pruritus
Adverse event was reported on Feb 28, 2014 by a Male taking Singulair (Dosage: Unk) was diagnosed with and. Location: US , 58 years of age, After Singulair was administered, patient encountered several Singulair side effects: rash, pruritus.

Confusional State, Intentional Self-injury, Social Avoidant Behaviour, Depression, Feeling Abnormal, Hallucination, Nightmare, Abdominal Pain Upper
on Feb 27, 2014 Female from GB , 25 years of age, weighting 213.0 lb, was diagnosed with and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: confusional state, intentional self-injury, social avoidant behaviour, depression, feeling abnormal, hallucination, nightmare, abdominal pain upper. Singulair dosage: 1 Df, Qd.

Nightmare, Insomnia, Middle Insomnia, Stress, Agitation, Screaming, Social Avoidant Behaviour, Confusional State, Hallucination
on Feb 25, 2014 Female from US , child 4 years of age, weighting 30.00 lb, was diagnosed with and was treated with Singulair. Patient felt the following Singulair side effects: nightmare, insomnia, middle insomnia, stress, agitation, screaming, social avoidant behaviour, confusional state, hallucination. Singulair dosage: 1 Once Daily. Patient was hospitalized.

Aggression, Feeling Abnormal, Nervousness, Paranoia
Patient was taking Singulair. After Singulair was administered, patient encountered several Singulair side effects: aggression, feeling abnormal, nervousness, paranoia on Feb 25, 2014 from US Additional patient health information: Female , child 6 years of age, weighting 31.00 lb, was diagnosed with and. Singulair dosage: N/A.

Ileus Paralytic, Prescribed Overdose
Adverse event was reported on Feb 21, 2014 by a Male taking Singulair Tablets 10mg (Dosage: 10 Mg, Qd) . Location: JP , child 8 years of age, Directly after, patient experienced the unwanted or unexpected Singulair side effects: ileus paralytic, prescribed overdose.

Depression, Anxiety, Depressed Mood, Crying
on Feb 18, 2014 Male from US , child 5 years of age, weighting 39.99 lb, was diagnosed with and was treated with Singulair. Patient felt the following Singulair side effects: depression, anxiety, depressed mood, crying. Singulair dosage: N/A.

Rib Fracture, Sneezing
on Feb 14, 2014 Female from US , 42 years of age, was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: rib fracture, sneezing. Singulair dosage: 10 Mg, Unk.

Suicide Attempt, Depression
Patient was taking Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: suicide attempt, depression on Feb 12, 2014 from GB Additional patient health information: Male , 43 years of age, weighting 187.0 lb, was diagnosed with and. Singulair dosage: 10 Mg, Unk.

Aggression, Autism, Personality Change, Suicidal Ideation
Adverse event was reported on Feb 10, 2014 by a Male taking Singulair (Dosage: 5 Mg, Unk) was diagnosed with and. Location: GB , child 6 years of age, Patient felt the following Singulair side effects: aggression, autism, personality change, suicidal ideation.
Multiple prescriptions taken:
  • Clenil Modulite
  • Loratadine
  • Salamol
  • Salmeterol


Overdose
on Feb 10, 2014 Female from US , 46 years of age, was diagnosed with and was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: overdose. Singulair dosage: 10 Mg, Qd.

Sinusitis, Incorrect Dose Administered
on Feb 06, 2014 Female from US , 57 years of age, was diagnosed with and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: sinusitis, incorrect dose administered. Singulair dosage: 5 Mg, Unk.

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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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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

    Safety Alerts, Active Ingredients, Usage Information

    Alternative SINGULAIR Names:MONTELUKA

    Active Ingredient: MONTELUKA

    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)]

     

    Latest Singulair clinical trials