Singulair Side Effects
How can Singulair Side Effects affect You? | PatientsVille.com
View and Submit Singulair Side Effects
Your Singulair Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
Record and Track Your Side Effects
It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.
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.
Alternative SINGULAIR Names:MONTELUKA
Active Ingredient: MONTELUKA
Side Effects reported to FDA: 6227. View Singulair Adverse Reports
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:
[06/12/2009, Updated 08/28/2009 - Healthcare Professional Sheet - FDA]
Previous MedWatch Alert:
[03/27/2008 - Singulair (montelukast)]
Singulair Adverse Reactions
Suicidal Ideation ( 959 Reports)|Depression ( 901 Reports)|Abnormal Behaviour ( 621 Reports)|Aggression ( 618 Reports)|Anxiety ( 600 Reports)|Allergic Granulomatous Angiitis ( 512 Reports)|Anger ( 347 Reports)|Insomnia ( 341 Reports)|Crying ( 303 Reports)|Mood Swings ( 285 Reports)|Asthma ( 284 Reports)|Headache ( 259 Reports)|Nightmare ( 247 Reports)|Mood Altered ( 244 Reports)|Fatigue ( 236 Reports)|Agitation ( 230 Reports)|Dyspnoea ( 220 Reports)|Irritability ( 213 Reports)|Suicide Attempt ( 209 Reports)|Overdose ( 176 Reports)|Abdominal Pain Upper ( 164 Reports)|Feeling Abnormal ( 156 Reports)|Hallucination ( 153 Reports)|Abnormal Dreams ( 146 Reports)|Fear ( 146 Reports)|Depressed Mood ( 144 Reports)|Completed Suicide ( 132 Reports)|Emotional Disorder ( 128 Reports)|Cough ( 124 Reports)|Pain In Extremity ( 124 Reports)|