MONTELUKAST & neuropsychiatric symptoms

 

 

`

JOURNAL OF MEDICINE AND SURGERY

2026 --  https://theantiseptic.in/special-article?slug=montelukast----neuropsychiatric-side-effects

 

.  MONTELUKAST --  neuropsychiatric  side-effects   .

 

RAMA  PRASAD  T.                                                                            

 

Dr. T. Rama Prasad,

Formerly:   Medical Superintendent (Special)  of  RTS & IRT  Perundurai Medical College and Research Centre,  

Perundurai, Tamil Nadu.          

Presently:  Director of ‘PAY WHAT YOU CAN’ Clinic, Perundurai, Erode District, TN – 638052.   

 

Specially Contributed to  “The Antiseptic”  

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“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 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

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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.   Hence, there is not much of an awareness and documentation of this side-effect in the country though too much of this drug is very widely 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 in 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  (7)  https://drtramaprasad.blogspot.com/2017/04/modern-medicine-good-bad-and-ugly_30.html  (8)  https://drtramaprasad.blogspot.com/2024/05/the-noble-profession.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) for 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 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.

 

Causality & validity  

• Post-marketing reports (including completed suicides) have been linked temporally to Montelukast use, often with preceding neuropsychiatric symptoms.
• Some large observational studies and systematic reviews find no strong association with suicide/depression overall in asthma patients, though risks may be higher for anxiety, insomnia, or in certain subgroups (e.g., older adults or children in some analyses).
• 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 HINDUnewspaper (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 it is generally inferior to inhaled corticosteroids (first-line for asthma) and not first-line 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 a 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.

Core concern  

The core concern is legitimate: Montelukast carries recognized neuropsychiatric risks (including rare suicidality), backed by 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): Reminders 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

 

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.  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”).  Many really died for not meeting with the expectations of the parents.  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%).   Read under the subheading “Stress in Children” in the writing titled “ Bringing up Children” in the link --  https://drtramaprasad.blogspot.com/2017/04/bringing-up-children_28.html  

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

• 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.  The increasing STRESS may be due to elevation of expectations, unrealistic goals, competition, comparison, and bad brought up of children (go t o  >  https://drtramaprasad.blogspot.com/2017/04/bringing-up-children_28.html  ).  12 students committed suicide in 37 days in 2026 when NEET test was cancelled (TOI, 20.6.2026).

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 key published scientific references along with a brief comment on neuropsychiatric side effects associated with Montelukast (Singulair), a leukotriene receptor antagonist used for asthma and allergic rhinitis.

Literature includes observational studies, systematic reviews, pharmacovigilance analyses, case reports, and regulatory reviews. Findings are mixed: some observational studies and reports link Montelukast to increased risks (e.g., anxiety, insomnia, depression, sleep disturbances, agitation, hallucinations, or suicidality), while others (especially in children) find no significant association compared to alternatives. The FDA added a boxed warning in 2020 for serious neuropsychiatric events.

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

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 strong 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

 

 

 

        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 hundreds of 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 recipient of the “Lifetime Achievement Award” of the ‘Coimbatore Respiratory Society’, and the honorific title  “Perundurai Rathinam” from the body of  ‘Perundurai Public’.

 

        He is the former MEDICAL SUPERINTENDENT (Special) of                       R.T. Sanatorium & Perundurai Medical College and Research Centre.

 

Dr. T. Rama Prasad

... a composed creature away from the gamut of emotions --  from euphoria to dejection.

MONTELUKAST  & neuropsychiatric symptoms   2026

https://drtramaprasad.blogspot.com/2023/01/montelukast-neuropsychiatric-symptoms.html  

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 and Fenformin – to mention a few.

Vega, a 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 --  the annual sales of Montelukast (April 2023–2024) reached over Rs. 2400 crore !

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. In March 2020, the US FDA affixed a black box warning (its strongest type) for 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 2008/2009), and many healthcare providers/patients were unaware of the risks. They advised restricting 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 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.

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.

Regarding causality and validity:

• Post-marketing reports (including completed suicides) have been linked temporally to Montelukast use, often with preceding neuropsychiatric symptoms.
• Some large observational studies and systematic reviews find no strong association with suicide/depression overall in asthma patients, though risks may be higher for anxiety, insomnia, or in certain subgroups (e.g., older adults or children in some analyses).
• 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.
• 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 neuro side effects. 

 “MONTELUKAST :  overused, overprescribed, and dangerous”  is the  title of an article published in THE HINDUnewspaper (September 11, 2024) and written by Dr. Sanjitha Muneeswaran and  Dr. Lancelot (M.) Pinto.

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 it is generally inferior to inhaled corticosteroids (first-line for asthma) and not first-line 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 a UK teen's suicide linked to the drug have fuelled global advocacy for restrictions.
• In India, sales are high and rising (over ₹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.

The core concern is legitimate: Montelukast carries recognized neuropsychiatric risks (including rare suicidality), backed by 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. 

 

To know a little about these diseases click on :  

https://drtramaprasad.blogspot.com/2017/04/asthma-allergy-copd_29.html

 

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.  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

• 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. 

                             Dr. T. Rama Prasad,  Perundurai,  India

 If you have more time to waste,  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  

  

 

 

MAD billionaire in 2025

That was the news in 2025 of the billionaire Elon Musk.  Today (June 5, 2026) it’s the news that his wealth had increased so much to make him the first TRILLIONAIRE in the world !  Perhaps, it’s the result of MADNESS after wealth !!!   It’s now for the biographer Seth Abramson to explain.

RICH trillionaire in 2026

 

MONTELUKAST  

and  neuropsychiatric  symptoms

Vega, a medical student, posed a poignant question: “Sir, MONTELUKAST is very commonly prescribed in India for patients with allergy with or without asthma, along with other medicines, whereas in countries like the USA, the UK and Australia it is discretely used.  Why ?”         Yes, caution is exercised in various countries (due to warnings and regulations) while, in India, this drug is largely used routinely and 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 --  the annual sales of Montelukast (April 2023–2024) reached over Rs. 2400 crore !

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. In March 2020, the US FDA affixed a black box warning (its strongest type) for 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 2008/2009), and many healthcare providers/patients were unaware of the risks. They advised restricting 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 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.

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. The side effects 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 2008/2009), and that many healthcare providers/patients were unaware of the risks. They advised restricting 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.

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.

Regarding causality and validity:

• Post-marketing reports (including completed suicides) have been linked temporally to Montelukast use, often with preceding neuropsychiatric symptoms.
• Some large observational studies and systematic reviews find no strong association with suicide/depression overall in asthma patients, though risks may be higher for anxiety, insomnia, or in certain subgroups (e.g., older adults or children in some analyses).
• 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.
• 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.

In India, Montelukast remains widely overused and overprescribed.  Some Indian specialists   have echoed the global concerns, advising caution or avoiding it in mild cases due to these potential neuro side effects.   The core concern is legitimate: Montelukast carries recognized neuropsychiatric risks (including rare suicidality), backed by 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. 

 

 

If you have the time to waste,  click on : 

https://drtramaprasad.blogspot.com/2017/04/asthma-allergy-copd_29.html

 

 

NEUROPSYCHIATRIC  symptoms

In India, the neuropsychiatric symptoms (with or without Montelukast) are not well recognised,  not well acknowledged, annd not well documented (both by people and doctors).  And there are no broad-based and well-structured comprehensive and robust studies on the subject.  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

• 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. 

                             Dr. T. Rama Prasad,  Perundurai,  India

 If you have the time to waste,  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  

 

 

MAD billionaire in 2025

That was the news in 2025 of the billionaire Elon Musk.  Today (June 5, 2026) it’s the news that his wealth had increased so much to make him the first TRILLIONAIRE in the world !  Perhaps, it’s the result of MADNESS after wealth !!!   It’s now for the biographer Seth Abramson to explain.