"The person who takes medicine must recover twice, once from the disease , and once from the medicine"
---- William Osler
ABSTRACT
True to this quote, an
unanticipated need to treat both the disease (allergy & asthma) and the
neuropsychiatric side-effects of Montelukast seems to have arisen. Confusingly,
both the disease (with chronic stressful suffering) and the drug may have common
neuropsychiatric manifestations like anxiety, depression, etc. In India,
not many doctors pointed
out these side-effects or documented them.
The related literature, largely from western
countries, is reviewed which yielded some idea about the extent and
seriousness of the side-effects of Montelukast. The impressions gained are documented in this article. According to many experts, the problem is
paramount, of serious concern, warranting regulations, while some studies found that no such side-effects were associated with the
drug. The commonalities of the symptoms
attributable to both the disease
and the drug may lead to errors
in clinical judgment. Let’s
hope for that stroke of serendipity which may facilitate control of both the
disease and the side-effects of the drug by a common approach.
Key words: Montelukast, Neuropsychiatric side-effects, Allergy, Asthma, Stress
Introduction
Montelukast, a leukotriene receptor antagonist, was approved to be prescribed daily in the oral form for long-term use as a “preventer” or “controller” of asthma and allergic rhinitis. Certain reports indicate that the drug may cause ‘neuropsychiatric’ side-effects.
The drug is commonly prescribed in India for allergy and asthma, but side-effects are not many on record. In this country, in general, patients do not recognize and complain about mild neuropsychiatric manifestations, and also they stubbornly shun psychiatric consultation, unlike in the West. Moreover, some of the neuropsychiatric symptoms (anxiety, depression, etc.) may be common to the chronically worrying ailment itself (allergy and asthma) and the side-effects of the drug. One can’t be sure about the causality, especially when many people, including doctors, have manifestations of stress. Hence, there is not much of an awareness and documentation of this side-effect in the country though this drug is very extensively used owing to aggressive marketing and poor regulation -- the annual sales of Montelukast (April 2023–2024) reached over Rs. 2400 crore ! A brief overview on this subject from a global perspective is presented below.
A thought-provoking question
Vega, an
inquisitive medical student, posed a poignant question: “Sir, MONTELUKAST
is very commonly prescribed in India for patients with allergy and / or
asthma, along with or without other medicines, whereas in countries like the
USA, the UK and Australia it is discretely used in a limited way. Why ?”
Yes, caution is exercised in various countries (due to warnings and regulations) while, in India, this drug is largely used routinely and often irrationally with little warning and regulation. It is very common to see Montelukast in the prescriptions given for Allergy / Asthma. The sale of the drug in India increased exponentially to Rs. 2,400 crore in the financial year of 2023-24.
Marketing Monsters
We create MONSTERS to protect us.
When they start biting us, we try to run away from them. But they pursue us like our shadows !!! Is MONTELUKAST another monster ? We think that Montelukast can protect
us from ALLERGY & ASTHMA,
In the past, we created many ‘monsters’ (drugs), and banned or
regulated them --hundreds of ‘combination drugs’ and many ‘single drugs’ like
Nimesulide, Phenophthalein, Sibutramine, Cisapride, Phenyl propanolamine,
Analgin, Refocoxib, Astemizole, Terfenadine,
fenfluramine, Fenformin, Vioxx, Zelnorm, Baycol,
Rosiglitazone, Troglitazone,
Rimonabrant and the monstrous Thalidomide
of 1961 – to mention a few.
NIMESULIDE tablets were banned 25 years ago (in 2000) in various
countries like Switzerland, Spain and the USA.
However, it took 25 years for India to ban this drug in December 2025,
and that too in a limited measure
-- only one kind of the nimesulide tablets. Why is there a delay of 25 years ? And, why the other kinds of the drug
continue to be available ? Is it to
protect the people or the drug manufacturers ?
Mediator (Benfluorex) drug scandal
is a historical reminder of deploying dangerous drugs to make money, facilitated by unhealthy nexus between drug
industry, drug regulators, doctors and politicians. This drug had a tumultuous presence in the market for 33 years
and killed around
2,000 people. The drug was promoted to control hyperlipidaemia, diabetes and obesity. To know about the saga, click on https://www.thelancet.com/action/showPdf?pii=S0140-6736%2811%2960334-6 . There must be many other drugs that may cause, as yet
undetected, serious side effects.
Not transparent
Of late, as seen with the case of Mediator drug scandal,
the credibility level in the professional fields has come down. Out of vested interests, the efficacy of
drugs may be glorified, in some cases through “paid research”, while suppressing information on
side-effects. There are various kinds of
players in this game as mentioned above. Influencers
painted a rosy picture about Montelukast while certain voices were vociferously
contradictory -- https://montelukastsideeffects.info/media-families-urge-warnings/ . Drug
industry is a well-oiled machinery.
Read
my writings at –
(1)https://drtramaprasad.blogspot.com/2017/03/medical-literature.html ;
(2)https://drtramaprasad.blogspot.com/2017/04/hydroxychloroquine-hcq-and-
coronavirus_29.html ;
(3)https://drtramaprasad.blogspot.com/2017/04/medical-conferences-clinical-meetings_30.html . What a fiasco ! Want to read more ? Go to >
(4)https://drtramaprasad.blogspot.com/2020/02/over-healthcare.html
(5)https://drtramaprasad.blogspot.com/2023/01/covid-vaccines-safe-or-unsafe.html
(6) https://drtramaprasad.blogspot.com/2017/04/science-and-nonsense-about-covid.html
Who is responsible ?
To err is human. But,
obviously, these are deliberate manipulations.
Course correction after making
mistakes requires resilience and reflective thinking.
As the lines in Batman
Begins go, “Why do we fall, Bruce ? So we can learn to pick ourselves up.” But greed made us impervious to the message.
Numerous people died due to
drugs. Who is to console the kith and kin? The parakeets in the
trees on the pavements offer commiserating squawks.
UK teen’s
Suicide
After the publication of various neuropsychiatric side-effects, including the suicide
of a 14-year-old British teenager Harry Miller in 2018, some countries issued regulatory warnings. Harry Miller died by suicide after
struggling to cope with mental health issues for two years. Miller, who had been suffering from
asthma, had been prescribed Montelukast on
an ongoing basis for two years. Similar
cases were reported elsewhere which caused a furore -- https://montelukastsideeffects.info/media-families-urge-warnings/ ) .
US FDA’s Black box warning
In March 2020, the US FDA affixed
a black box warning (its strongest
type) to Montelukast due to serious mental health side effects. These include
agitation, depression, sleep disturbances, hallucinations, anxiety, behavioural
changes, and, in some cases,
suicidal thoughts, actions, or suicides. The FDA noted that reports continued
even after earlier warnings (from 2008 to 2009), and many healthcare
providers/patients were unaware of the risks. They advised restricting the use
for allergic rhinitis / hay fever to cases where other treatments fail or aren't
tolerated, and to weigh benefits
vs risks for asthma, while monitoring
patients closely.
Montelukast vs corticosteroids
Montelukast was developed by Merck and Co in 1990, and was approved
by the FDA of USA in 1998. The
oral medication was approved to be prescribed daily for long-term use as a
“preventer” or “controller” of asthma and allergic rhinitis. There is universal
consensus, based on multiple comparative studies, that as a treatment for asthma,
the drug is inferior to inhaled corticosteroids, which are considered as the
first-line therapy for the control of the disease. For allergic rhinitis, most
guidelines across the world recommend intranasal corticosteroids and/or
antihistamines; Montelukast is not recommended as the first-line therapy. Of course, the steroids have their own
side effects. That’s a different
story.
Warnings by other regulators
The concerns about the neuropsychiatric side-effects of Montelukast, including rare cases
leading to suicidal thoughts or actions, are valid and well-documented in medical literature and recognised by
various international medical regulatory bodies.
Alerts similar to that of the FDA exist
from other regulators:
The
UK's MHRA (and later updates)
reminds prescribers to watch for neuropsychiatric reactions and
consider stopping if they occur.
Australia's TGA (as recently
as 2025) strengthened warnings, noting reports
of suicidality (including rare fatalities) across age groups.
Events are generally rare (e.g., suicidal
behaviour very rare,
<1 in 10,000
in some estimates), but can
be serious and persist if not addressed promptly.
The concerns about the neuropsychiatric side-effects of Montelukast, including rare cases
leading to suicidal thoughts or actions, are valid and well-documented in medical literature and recognised by
various international medical regulatory bodies.
Australia's TGA (as recently
as 2025) strengthened warnings, noting reports
of suicidality (including rare fatalities) across age groups.
Events are generally rare (e.g., suicidal
behaviour very rare,
<1 in 10,000
in some estimates), but can
be serious and persist if not addressed promptly.
Causality & validity
Post-marketing reports (including completed suicides) have been linked temporally to Montelukast use, often with preceding neuropsychiatric symptoms.
Recent meta-analyses suggest a modest
increased risk for anxiety but not consistently for depression or suicidal
behaviours.A 2025 study in children/adolescents found no increased
risk for neuropsychiatric events.
Causality is not always established (confounded by the nature of the disease,
e.g., asthma itself is linked to psychiatric issues). Risks may vary by
age (potentially higher in younger patients in some studies).
Overall, the evidence
supports the warnings
as precautionary and evidence-based, not that the drug always causes these
effects, but that they can occur (sometimes reversibly upon discontinuation),
and alternatives should be considered when possible, especially for mild cases.
While caution
is being exercised everywhere, the sale of this drug in India is unregulated, largely irrational, and
seems to be increasing exponentially
In India, Montelukast remains widely used for asthma
and allergies, and there have been discussions and op-eds highlighting overuse and risks. Some Indian doctors
and articles have echoed
global concerns, advising
caution or avoiding
it in mild cases due to these potential neuropsychiatric
side-effects.
Post-marketing reports (including completed suicides) have been linked temporally to Montelukast use, often with preceding neuropsychiatric symptoms.
Recent meta-analyses suggest a modest
increased risk for anxiety but not consistently for depression or suicidal
behaviours.A 2025 study in children/adolescents found no increased
risk for neuropsychiatric events.
Causality is not always established (confounded by the nature of the disease,
e.g., asthma itself is linked to psychiatric issues). Risks may vary by
age (potentially higher in younger patients in some studies).
Overall, the evidence
supports the warnings
as precautionary and evidence-based, not that the drug always causes these
effects, but that they can occur (sometimes reversibly upon discontinuation),
and alternatives should be considered when possible, especially for mild cases.
While caution
is being exercised everywhere, the sale of this drug in India is unregulated, largely irrational, and
seems to be increasing exponentially
In India, Montelukast remains widely used for asthma
and allergies, and there have been discussions and op-eds highlighting overuse and risks. Some Indian doctors
and articles have echoed
global concerns, advising
caution or avoiding
it in mild cases due to these potential neuropsychiatric
side-effects.
“MONTELUKAST : overused,
overprescribed, and dangerous” is the title of an article published in THE HINDU newspaper (September 11, 2024) and written by Dr.
Sanjitha Muneeswaran and Dr. Lancelot
(M.) Pinto -- https://www.thehindu.com/opinion/op-ed/montelukast-overused-overprescribed-and-dangerous/article68625919.ece .
Sanjitha Muneeswaran is a
doctor (pulmonologist/respiratory medicine specialist) affiliated with PD
Hinduja National Hospital and Medical Research
Centre in Mumbai.
She is also involved in research and publications on respiratory topics like acute
respiratory infections, tuberculosis, and interstitial lung disease.
The co-author is Dr. Lancelot (M.)
Pinto, a Consultant Pulmonologist and Epidemiologist at the
same hospital (PD Hinduja). He is a clinician-researcher focused
on respiratory diseases, patient self-management,
and public health aspects of lung conditions.
Brief on the Article
In their September 11, 2024 ‘opinion piece’ in The Hindu ("Montelukast: overused,
overprescribed, and dangerous"), they argue that Montelukast (a leukotriene receptor antagonist sold as Singulair and generics) is being
overused and irrationally prescribed in India,
especially for short-term use in combinations with antihistamines for mild symptoms or allergies.
Key points
they raised:
·
It was approved
for long-term daily
use as a controller for asthma and allergic rhinitis, but evidence shows that it is
generally inferior to inhaled
corticosteroids (first-line for asthma) and that it is not the first-line
option for allergic rhinitis (where intranasal steroids/antihistamines are
preferred).
·
Significant safety concerns, including neuropsychiatric side-effects (e.g.,
anxiety, depression, mood changes,
aggression, sleep issues,
and rare suicidality), prompted FDA black-box warnings
and alerts from other regulators. Cases like the UK teen's suicide linked to the drug have
fuelled global advocacy for restrictions.
·
In India, sales are high and rising
(over Rs. 2,400
crore / USD 320 million annually around that time),
with little regulation, despite global caution.
They call for stricter
oversight, better adherence to guidelines, and reduced irrational use.
The article highlights the mismatch between
international safety signals
and lax practices in India.
Key points
they raised:
·
It was approved
for long-term daily
use as a controller for asthma and allergic rhinitis, but evidence shows that it is
generally inferior to inhaled
corticosteroids (first-line for asthma) and that it is not the first-line
option for allergic rhinitis (where intranasal steroids/antihistamines are
preferred).
· Significant safety concerns, including neuropsychiatric side-effects (e.g., anxiety, depression, mood changes, aggression, sleep issues, and rare suicidality), prompted FDA black-box warnings and alerts from other regulators. Cases like the UK teen's suicide linked to the drug have fuelled global advocacy for restrictions.
·
In India, sales are high and rising
(over Rs. 2,400
crore / USD 320 million annually around that time),
with little regulation, despite global caution.
They call for stricter
oversight, better adherence to guidelines, and reduced irrational use.
Core concern
The core concern
is legitimate: Montelukast carries
recognized neuropsychiatric risks
(including rare suicidality), resulting in regulatory actions worldwide. Doctors
should discuss these with
patients / caregivers, monitor for mood / behaviour changes, and consider
alternatives (e.g., inhaled corticosteroids for asthma and intranasal
corticosteroids for nasal allergy) if risks outweigh benefits.
Regulatory
information
FDA (2020) boxed warning and Sentinel System analysis: Serious
events reported (including
suicidality), though some large comparisons to inhaled corticosteroids showed
no clear excess risk for hospitalization / self-harm. FDA
MHRA/TGA updates (UK/Australia): Remind
on risks (sleep
disorders, depression,
agitation, rare suicidality); advise discontinuation if symptoms occur. Tga
To read a little ‘scribbling’ on these diseases,
click on :
https://drtramaprasad.blogspot.com/2017/04/asthma-allergy-copd_29.html
MHRA/TGA updates (UK/Australia): Remind on risks (sleep disorders, depression, agitation, rare suicidality); advise discontinuation if symptoms occur. Tga
NEUROPSYCHIATRIC symptoms
In India, the
neuropsychiatric symptoms (with or without Montelukast) are not well recognised and not well documented (both
by people and doctors). And there are no broad-based and well-structured
comprehensive and robust studies on the subject in the country. However, some
large-scale studies, including the Global Burden of Disease (GBD) study
and India's National Mental Health Survey (NMHS 2016) indicate that in 2017
approximately 197.3 million people
in India (about 14.3% of the
population) had mental disorders.
And it is difficult to come to the conclusion that the symptoms in
some cases are due to Montelukast, as
the symptoms might have already been present unidentified, and detected during
the course of treatment. Many Indian
students do have the symptoms due to enormous stress in coping with studies and
scoring high marks (marks-oriented education with a lot of pressure from parents and others “to do or die”). Studies
indicate that even after
scoring high marks and getting admitted into a medical college, the stress
persists in many cases. "The NATIONAL MEDICAL COMMISSION (NMC) has revealed in August 2024
that an alarming number of MBBS students have
MENTAL HEALTH DISORDERS (28%) and suicidal ideation
(16%).
This problem is present among
other students also,
and also among
the public -- more
so, after the onset of the COVID pandemic. Post-COVID
(Long COVID) studies in India report
neuropsychiatric symptoms (e.g., anxiety 9-13%,
depression 9-10%, stress 10%, cognitive issues 5%) in recovered individuals, sometimes affecting 30-40% with persistent symptoms.
Important Notes
And it is difficult to come to the conclusion that the symptoms in some cases are due to Montelukast, as the symptoms might have already been present unidentified, and detected during the course of treatment. Many Indian students do have the symptoms due to enormous stress in coping with studies and scoring high marks (marks-oriented education with a lot of pressure from parents and others “to do or die”). Studies indicate that even after scoring high marks and getting admitted into a medical college, the stress persists in many cases. "The NATIONAL MEDICAL COMMISSION (NMC) has revealed in August 2024 that an alarming number of MBBS students have MENTAL HEALTH DISORDERS (28%) and suicidal ideation (16%).
This problem is present among other students also, and also among the public -- more so, after the onset of the COVID pandemic. Post-COVID (Long COVID) studies in India report neuropsychiatric symptoms (e.g., anxiety 9-13%, depression 9-10%, stress 10%, cognitive issues 5%) in recovered individuals, sometimes affecting 30-40% with persistent symptoms.
Treatment gaps remain large
(often >80% for many conditions like anxiety), due to stigma, access issues, and
under-diagnosis.
Prevalence varies by region (higher in urban/metropolitan
areas), gender (e.g., anxiety/depression higher
in females; substance use higher in males), socioeconomic status, and age.
The burden has increased over time (e.g.,
mental disorders’ share of DALYs rose from 2.5%
in 1990 to 4.7% in 2017), driven
by population growth,
aging, and lifestyle
changes.
These figures
highlight a substantial public health challenge in India, with common symptoms
like those in depression, anxiety, and substance-related issues being
prominent. For the most current or specific sub-population data, consulting recent NMHS updates
or GBD reports is recommended.
Treatment gaps remain large
(often >80% for many conditions like anxiety), due to stigma, access issues, and
under-diagnosis.
Prevalence varies by region (higher in urban/metropolitan
areas), gender (e.g., anxiety/depression higher
in females; substance use higher in males), socioeconomic status, and age.
The burden has increased over time (e.g.,
mental disorders’ share of DALYs rose from 2.5%
in 1990 to 4.7% in 2017), driven
by population growth,
aging, and lifestyle
changes.
These figures
highlight a substantial public health challenge in India, with common symptoms
like those in depression, anxiety, and substance-related issues being
prominent. For the most current or specific sub-population data, consulting recent NMHS updates
or GBD reports is recommended.
This seems to be a part of the evolution due to changes in mind set and lifestyle, and the resultant STRESS in life coupled with increasingly unrealistic goals.
For more,
click on :
(1)Mental Health
-- https://drtramaprasad.blogspot.com/2023/01/mental-health.html
(2)Stress & Psychosis -- https://drtramaprasad.blogspot.com/2023/01/fear-stress-and-psychosis.html
REFERENCES
For more,
click on :
(1)Mental Health -- https://drtramaprasad.blogspot.com/2023/01/mental-health.html
(2)Stress & Psychosis -- https://drtramaprasad.blogspot.com/2023/01/fear-stress-and-psychosis.html
REFERENCES
Here is a list of some of the published scientific key references along with a brief comment on neuropsychiatric side effects associated with Montelukast (Singulair), a leukotriene receptor antagonist used for asthma and allergic rhinitis.
Major Observational Studies and Cohorts
Paljarvi et al. (2022): "Analysis of Neuropsychiatric Diagnoses After Montelukast Initiation in Patients With Asthma or Allergic Rhinitis." Cohort study (72k asthma and 82k allergic rhinitis patients). Found modestly increased odds of neuropsychiatric outcomes (e.g., anxiety OR 1.21 in asthma; insomnia OR 1.15 in rhinitis). Jamanetwork
Jordan et al. (2023): "Psychiatric Adverse
Effects of Montelukast—A Nationwide Cohort Study." Danish registers; increased risk of neuropsychiatric medicine use (HR
1.14) and hospital contacts (stronger in younger adults 18–29). Pubmed.ncbi.nim.nih
Wintzell et al. (2025): "Montelukast Use and the Risk of Neuropsychiatric Adverse Events in Children and
Adolescents." Large cohort;
no association with neuropsychiatric events vs long-acting beta-agonists (HR
0.99). Pubmed.ncbi.nim.nih
Lo et al. (2023): "Neuropsychiatric events associated with Montelukast in patients
with asthma: a systematic review." Reviewed
59 studies; possible links to
anxiety/sleep disorders in adults but not consistently to suicide/depression; weaker or
no signals in children. Publications.ersnet
Jordan et al. (2023): "Psychiatric Adverse
Effects of Montelukast—A Nationwide Cohort Study." Danish registers; increased risk of neuropsychiatric medicine use (HR
1.14) and hospital contacts (stronger in younger adults 18–29). Pubmed.ncbi.nim.nih
Meta-Analyses and Reviews
Sobczak et al. (2025): "Montelukast: risk of mental
disorders vs efficacy
-- a meta-analysis." Modest
increase in anxiety risk (RR 1.11); no
consistent increase in depression or suicidal behaviours. Frontiers.in
Maideen et al. (2024): Review summarizing consistent reports of agitation, anxiety, depression, hallucinations, sleep issues, and
suicidality across ages. ScienceDirect
Other Notable Studies
Kim et al. (various, 2023–2024): Population-based studies in children/adolescents;
mixed or no overall increased risk, with some signals for specific events like
hallucinations/attention issues. Bmjpaedsopen.bmj
Lei et al. (2025): Duration
analysis in children;
overall no broad increase, but possible elevated tics/Tourette’s with
prolonged use in ages 6–15. Mdpi
Earlier
pharmacovigilance/case series (e.g., Perona et al. 2016; various FAERS
analyses) highlight spontaneous reports of aggression, nightmares, depression,
anxiety, and suicidality, often resolving on discontinuation. Publications.ersnet
PubMed or journal links
(e.g., via DOI or search):
Search PubMed for "Montelukast
neuropsychiatric" for full texts/abstracts. Many are ‘open-access’ or via
PMC.
*****************************
“The big business
barons are so influential that they may not allow a ban on Montelukast, but may reconcile to a regulatory handicap.” -- T. Rama Prasad
“Science like life, feeds on its own decay. New facts burst old rules; then newly divined
conceptions bind old and new together into a reconciling law.” -- William
James
ABOUT THE AUTHOR,
Dr.
T. Rama Prasad is the WORLD RECORD holder of authoring 28 articles related to
COVID-19 in 30 months, published
in a medical journal (The Antiseptic – www.theantiseptic.in -- Indexed in IndMED),
and reporting in the same journal the WORLD’s FIRST CASE of ‘Yellow Nail Syndrome’ associated with COVID-19, PT &
DM (https://drtramaprasad.blogspot.com/2017/04/yellow-nail syndrome_28.html ).
Interestingly, he reported the first case of YNS from India in an American
medical journal long ago in 1980.
He wrote
his first article in the premier journal,
The Antiseptic, four decades ago. Many of his articles written
over half-a-century may be accessed
at https://drtramaprasad.blogspot.com/2017/04/dr-t-rama-prasad.html& https://drtramaprasad.blogspot.com/2017/04/my-in-newspapers_28.html
https://drtramaprasad.blogspot.com
.
He is the former MEDICAL
SUPERINTENDENT (Special) of R.T. Sanatorium & Perundurai Medical College and Research Centre.
.