Question about Singulair: side effects?

abpdjs

Carson has been on it for about 2.5 weeks.

I have heard/read that it can cause mood problems.  I am going to call the pedi about it today.  Anyone have any input?TIA!

Read2Me

Eva has been on it for a little over a year and there haven't been any noticeable side effects but I have heard about the mood issues.  Good luck! 

howleyshell

I'm a former drug rep (not for this drug tho!)

Here's the verbage from the prescribing information:

5.4 Neuropsychiatric Events 

Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking 

SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or 

hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, 

irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. 

The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug- 

induced effect. 

Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to 

notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits 

of continuing treatment with SINGULAIR if such events occur [see Adverse Reactions (6.2)].

 

AND:

 

 

Pediatric Patients 2 to 5 Years of Age with Asthma 

SINGULAIR has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and 

multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with 

SINGULAIR for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in 

clinical trials. In pediatric patients 2 to 5 years of age receiving SINGULAIR, the following events occurred 

with a frequency =2% and more frequently than in pediatric patients who received placebo: fever, cough, 

abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, 

eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis. 

 

Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis 

SINGULAIR has been evaluated in 280 pediatric patients 2 to 14 years of age in a 2-week, 

multicenter, double-blind, placebo-controlled, parallel-group safety study. SINGULAIR administered once 

daily in the evening had a safety profile similar to that of placebo. In this study, the following events 

occurred with a frequency =2% and at an incidence greater than placebo: headache, otitis media, 

pharyngitis, and upper respiratory infection. 

 

and the 2 biggest neurological/psychiatric issues were headache and dizziness  (1st set of #'s = singulair, 2nd set of #'s = placebo.  The table didn't paste very pretty:  The heavy duty stuff mentioned above didn't even make the adverse events chart so I'm thinking it's a VERY small portion of patients who will experience it.

TABLE 1 

Adverse Experiences Occurring in =1% of Patients  

with an Incidence Greater than that in Patients Treated with Placebo 

 

 

  SINGULAIR 

10 mg/day 

(%) 

(n=1955) 

 

Placebo 

 

(%) 

(n=1180) 

 

Body As A Whole 

Pain, abdominal 

Asthenia/fatigue 

Fever 

Trauma 

 

 

  2.9 

  1.8 

  1.5 

  1.0 

 

  2.5 

  1.2 

  0.9 

  0.8 

Digestive System Disorders 

Dyspepsia 

Pain, dental 

Gastroenteritis, infectious 

 

 

  2.1 

  1.7 

  1.5 

 

 

  1.1 

  1.0 

  0.5 

 

Nervous System/Psychiatric 

Headache 

Dizziness 

 

 

18.4 

  1.9 

 

 

 18.1 

  1.4 

Respiratory System Disorders 

Influenza 

Cough 

Congestion, nasal 

 

 

  4.2 

  2.7 

  1.6 

 

  3.9 

  2.4 

  1.3 

Skin/Skin Appendages Disorder 

Rash 

 

 

  1.6  

  1.2 

Laboratory Adverse Experiences* 

ALT increased 

AST increased 

Pyuria 

 

  2.1 

  1.6 

  1.0 

 

  2.0 

  1.2 

  0.9