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Singulair Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 6227 

Syncope, Epistaxis (8453598-0)
on Jun 14, 2012 Male from PORTUGAL , child 4 years of age, was diagnosed with
  • rhinitis seasonal
and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: syncope, epistaxis. Singulair dosage: N/A.

Right Ventricular Failure, Status Asthmaticus (8451784-7)
Patient was taking Singulair. Patient felt the following Singulair side effects: right ventricular failure, status asthmaticus on Jun 15, 2012 from GERMANY Additional patient health information: Male , 20 years of age, . Singulair dosage: N/A.
Multiple prescriptions taken:
  • Albuterol Sulfate Autohaler
  • Enalapril Maleate
  • Xolair
  • Fluticasone Propionate
  • Formoterol Fumarate


Fatigue, Dizziness, Nausea, Dyspnoea, Decreased Appetite (8451776-8)
Adverse event was reported on Mar 18, 2012 by a Male taking Singulair (Dosage: N/A) . Location: , weighting 170.2 lb, After Singulair was administered, patient encountered several Singulair side effects: fatigue, dizziness, nausea, dyspnoea, decreased appetite.
Multiple concurrent drugs taken:
  • Incivek
  • Cyclobenzaprine
  • Ibuprofen
  • Symbicort
  • Ribavirin
  • Peginterferon Alfa-2a


Gastrooesophageal Reflux Disease, Gastrointestinal Pain (8448310-5)
on Jun 07, 2012 Female from UNITED STATES , 55 years of age, was diagnosed with
  • asthma
and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: gastrooesophageal reflux disease, gastrointestinal pain. Singulair dosage: N/A.
Associated medications used:
  • Symbicort



Weight Increased, Blood Thyroid Stimulating Hormone Increased, Feeling Abnormal, Sleep Disorder, Insomnia (8447141-X)
on Jun 27, 2011 Female from UNITED STATES , 43 years of age, weighting 220.0 lb, was diagnosed with
  • seasonal allergy
  • thyroidectomy
and was treated with Singulair. Patient felt the following Singulair side effects: weight increased, blood thyroid stimulating hormone increased, feeling abnormal, sleep disorder, insomnia. Singulair dosage: Unk.
Multiple prescriptions taken:
  • Levoxyl (100 Ug, 1x/day)
  • Levoxyl (250 Ug, 1x/day)
  • Nexium (Unk)
  • Azelastine Hydrochloride (Unk)
  • Iron (Unk)
  • M.v.i. (Unk)
  • Levoxyl (200 Mcg (titrated To 150 Mcg, 175 Mcg Then 200)
  • Zyrtec (Unk)


Small Intestine Carcinoma (8446991-3)
Patient was taking Singulair. After Singulair was administered, patient encountered several Singulair side effects: small intestine carcinoma on Jun 12, 2012 from FRANCE Additional patient health information: Female , weighting 136.7 lb, was diagnosed with
  • asthma
and. Singulair dosage: 5 Milligram.
Multiple concurrent drugs taken:
  • Aldactazine (25 Milligram)
  • Pravastatin (20 Milligram)
  • Tramadol Hcl (200 Milligram)
  • Primalan
  • Aspirin (75 Milligram)
  • Fluticasone Propionate/salmeterol (1000 Microgram)
  • Nasacort (110 Microgram)
  • Voltaren


Hearing Impaired, Fatigue, Bursitis, Malaise, Somnolence (8446165-6)
Adverse event was reported on May 21, 2012 by a Female taking Singulair (Dosage: N/A) . Location: UNITED STATES , 87 years of age, weighting 179.9 lb, Directly after, patient experienced the unwanted or unexpected Singulair side effects: hearing impaired, fatigue, bursitis, malaise, somnolence.
Associated medications used:
  • Calciferol
  • Prilosec
  • Chlor-trimeton
  • Prilosec


Blood Uric Acid Increased, Hyperuricaemia (8443686-7)
on Jun 11, 2012 Male from UNITED STATES , weighting 308.6 lb, was diagnosed with
  • multiple allergies
  • hypertension
and was treated with Singulair. Patient felt the following Singulair side effects: blood uric acid increased, hyperuricaemia. Singulair dosage: N/A.
Multiple prescriptions taken:
  • Torsemide
  • Torsemide
  • Caltrate +d
  • Caltrate +d
  • Lasix
  • Tramadol Hcl
  • Lantus
  • Novolog (Every Evening)


Dry Mouth, Hypertonic Bladder, Glaucoma (8443095-0)
on Jun 12, 2012 Male from UNITED STATES , weighting 142.0 lb, was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: dry mouth, hypertonic bladder, glaucoma. Singulair dosage: Unk.
Multiple concurrent drugs taken:
  • Caduet (Unk, 1x/day)
  • Benadryl (Unk)
  • Toviaz (4 Mg, 1x/day)


Application Site Erythema, Product Quality Issue, Headache (8442609-4)
Patient was taking Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: application site erythema, product quality issue, headache on Nov 17, 2011 from UNITED STATES Additional patient health information: Female , child 11 years of age, weighting 140.0 lb, was diagnosed with
  • sinus disorder
  • attention deficit/hyperactivity disorder
and. Singulair dosage: N/A.
Associated medications used:
  • Daytrana (10 Mg, Qd)
  • Flonase
  • Claritin /00413701/


Sleep Terror, Logorrhoea (8442378-8)
Adverse event was reported on Jan 05, 2012 by a Male taking Singulair (Dosage: N/A) was diagnosed with
  • asthma
  • attention deficit/hyperactivity disorder
  • tic
and. Location: UNITED STATES , child 7 years of age, Patient felt the following Singulair side effects: sleep terror, logorrhoea.
Multiple prescriptions taken:
  • Daytrana (10 Mg, Qd)
  • Tenex
  • Flonase


Product Quality Issue, No Adverse Event (8442054-1)
on Mar 07, 2012 Female from UNITED STATES , weighting 47.99 lb, was diagnosed with
  • hypersensitivity
and was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: product quality issue, no adverse event. Singulair dosage: N/A.
Multiple concurrent drugs taken:
  • Loratadine
  • Daytrana (10 Mg, Unk)


Product Quality Issue, No Adverse Event (8441719-5)
on Mar 19, 2012 Male from UNITED STATES , weighting 105.0 lb, was diagnosed with
  • seasonal allergy
  • attention deficit/hyperactivity disorder
and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: product quality issue, no adverse event. Singulair dosage: N/A.
Associated medications used:
  • Daytrana (10 Mg, Unk)


Product Quality Issue, Psychomotor Hyperactivity (8441117-4)
Patient was taking Singulair. Patient felt the following Singulair side effects: product quality issue, psychomotor hyperactivity on Jun 09, 2011 from UNITED STATES Additional patient health information: Male , child 12 years of age, . Singulair dosage: Unk.
Multiple prescriptions taken:
  • Daytrana (30 Mg, Qd)


Agitation, Tremor, Anxiety, Suicidal Ideation, Self-injurious Ideation, Nervousness, Anger (8439834-5)
Adverse event was reported on Jun 11, 2012 by a Female taking Singulair (Dosage: 10 Mg, Once Daily, Po) was diagnosed with
  • inner ear disorder
  • multiple allergies
and. Location: UNITED STATES , 45 years of age, weighting 132.0 lb, After Singulair was administered, patient encountered several Singulair side effects: agitation, tremor, anxiety, suicidal ideation, self-injurious ideation, nervousness, anger.

Dysphonia, Dysphemia, Aggression (8438385-1)
on Jun 12, 2012 Female from UNITED STATES , weighting 30.86 lb, was diagnosed with
  • asthma
  • hypersensitivity
and was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: dysphonia, dysphemia, aggression. Singulair dosage: N/A.

Lymphoma (8434830-6)
on May 24, 2012 Female from UNITED STATES , 79 years of age, was treated with Singulair. Patient felt the following Singulair side effects: lymphoma. Singulair dosage: N/A.
Multiple prescriptions taken:
  • Furosemide
  • Lisinopril
  • Metoprolol Tartrate
  • Actonel (150 Mg Once Monthly, Oral 150 Mg, 1/month, Oral)
  • Actonel (150 Mg Once Monthly, Oral 150 Mg, 1/month, Oral)
  • Lovastatin
  • Spironolactone
  • Spiriva


Systemic Lupus Erythematosus (8434363-7)
Patient was taking Singulair. After Singulair was administered, patient encountered several Singulair side effects: systemic lupus erythematosus on Jun 05, 2012 from CANADA Additional patient health information: Female , 85 years of age, . Singulair dosage: N/A.
Multiple concurrent drugs taken:
  • Prednisone
Patient was hospitalized.

Sleep Terror, Overdose, Irritability (8434354-6)
Adverse event was reported on Jun 12, 2012 by a Male taking Singulair (Dosage: N/A) was diagnosed with
  • hypersensitivity
and. Location: SPAIN , child 11 years of age, Directly after, patient experienced the unwanted or unexpected Singulair side effects: sleep terror, overdose, irritability.

Antisocial Behaviour, Depression, Hostility, Irritability (8434342-X)
on Jun 12, 2012 Male from SPAIN , 13 years of age, was diagnosed with
  • asthma
and was treated with Singulair. Patient felt the following Singulair side effects: antisocial behaviour, depression, hostility, irritability. Singulair dosage: N/A.

Nervousness, Aggression, Suicidal Behaviour, Screaming, Insomnia, Agitation (8434333-9)
on Jun 07, 2012 Male from UNITED STATES , 14 years of age, weighting 125.7 lb, was diagnosed with
  • asthma
and was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: nervousness, aggression, suicidal behaviour, screaming, insomnia, agitation. Singulair dosage: N/A.

Anger, Fight In School, Physical Assault, Impulsive Behaviour, Screaming, Aggression, Visual Impairment, Conduct Disorder, Oppositional Defiant Disorder (8434330-3)
Patient was taking Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: anger, fight in school, physical assault, impulsive behaviour, screaming, aggression, visual impairment, conduct disorder, oppositional defiant disorder on Jun 12, 2012 from UNITED STATES Additional patient health information: Male , child 6 years of age, weighting 48.50 lb, was diagnosed with
  • eczema
and. Singulair dosage: N/A.

Irritable Bowel Syndrome, Chills, Dyspnoea, Back Pain, Crohn's Disease, Night Sweats, Urinary Tract Infection, Headache (8433008-X)
Adverse event was reported on Jun 07, 2012 by a Female taking Singulair (Dosage: N/A) . Location: UNITED STATES , weighting 141.6 lb, Patient felt the following Singulair side effects: irritable bowel syndrome, chills, dyspnoea, back pain, crohn's disease, night sweats, urinary tract infection, headache.
Multiple prescriptions taken:
  • Albuterol
  • Biotin
  • Folic Acid
  • Zofran
  • Prozac
  • Klonopin
  • Vsl 3
  • Humira


Asthma (8432965-5)
on Jun 08, 2012 Male from FRANCE , weighting 116.8 lb, was treated with Singulair. After Singulair was administered, patient encountered several Singulair side effects: asthma. Singulair dosage: N/A.
Multiple concurrent drugs taken:
  • Xolair
  • Airomir
  • Desloratadine
  • Ventolin
  • Fluticasone Propionate/salmeterol
Patient was hospitalized.

Cough, Incorrect Dose Administered, Peak Expiratory Flow Rate Decreased, Chest Discomfort (8432010-1)
on Nov 16, 2011 Female from UNITED STATES , 52 years of age, weighting 220.0 lb, was treated with Singulair. Directly after, patient experienced the unwanted or unexpected Singulair side effects: cough, incorrect dose administered, peak expiratory flow rate decreased, chest discomfort. Singulair dosage: N/A.
Associated medications used:
  • Symbicort (160/4.5 Mg 2 Puffs Twice A Day)
  • Rhinocort


Showing 1-25 of 6227 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative SINGULAIR Names:MONTELUKA

Active Ingredient: MONTELUKA

Singulair Dosage, Warnings, Usage.

Side Effects reported to FDA: 6227. View Singulair Adverse Reports

Singulair safety alerts: 2009 2008

Reported deaths: 242

Reported hospitalizations: 1949

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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