Skip to main content


Product Liability Lawyer representing plaintiffs nationwide in Pharmaceutical Recall Litigation & Drug Injury Cases
Nationwide Success

Montelukast Lawsuits

Investigating drug injury, FDA recalls & adverse events

Thank you for considering The Lyon Firm. At this time, we are not accepting plaintiffs related to this specific consumer issue. However, if you would like to be contacted in the future, please complete the contact form. By completing the form you will be contacted if the Firm begins accepting new cases on this matter, and you will also be included in firm news alerts related to important consumer safety and privacy issues to help keep you informed about related issues.

The U.S. Food and Drug Administration (FDA) announced a new boxed warning for Montelukast (Singulair), alerting the public of the risk of neuropsychiatric events, depression, suicidal thoughts and behavioral changes associated with the asthma and allergy drug.

The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms. Those taking Singulair who exhibit mood changing behaviors, nightmares, depression, disorientation, anxiety, hallucinations, irritability, restlessness, stuttering, or uncontrolled muscle movements should contact their prescribing physician.

The FDA issued the boxed Singulair warning after some experts determined the risks of montelukast use may outweigh the benefits for people with mild allergies. The FDA is also requiring a new Medication Guide to be given to patients with their prescription.

Joe Lyon is a Cincinnati, Ohio Drug Injury Attorney and Pharmaceutical Recall Lawyer reviewing FDA drug warnings and drug injury lawsuits on behalf of patients nationwide.

Montelukast & Depression

The FDA took action after a review of patient data led them to reevaluate the benefits and risks of Singulair use. The current prescribing information already includes warnings about mental health side effects and risks, including suicidal thoughts. However, the agency decided a stronger warnings is necessary.

The FDA announced that the drug should be reserved for patients who do not respond to other allergy medications or cannot tolerate other allergy medicines. For asthma patients, they recommend health care professionals consider the benefits and risks of mental health side effects before prescribing the drug.

Overall, depression is the most frequently reported Singulair side effect for both children and adults. Other common Singulair side effects include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection.

What is Montelukast?

Montelukast is a prescription drug approved for asthma and allergies. It is meant to prevent asthma attacks and treat long-term asthma in adults and children. The drug is also approved to control symptoms of allergic rhinitis.

Montelukast blocks substances in the body called leukotrienes to help improve symptoms. It is marketed under the brand name Singulair and as generics.

In 2018, over nine million patients received a prescription for montelukast from U.S. outpatient retail pharmacies. Singulair belongs to a class of drugs known as selective leukotriene receptor antagonists.  It is a top-selling medication in the U.S., with billions in annual sales.

Singulair Suicide Warnings

Both adults and children frequently report experiencing neurological side effects, according to research published in the medical journal Pharmacology Research & Perspectives.

In 2009 the FDA ordered a Singulair warning label update, adding information about suicide risks, suicidal thinking, aggression and other neuropsychiatric side effects.

The effectiveness of Singulair has been debated. Some doctors believe it is not an effective treatment for asthma, especially considering the widespread side effects and risks. A 2014 study indicated Singular did not prevent wheezing episodes among children who took the drug.

Reports of neuropsychiatric adverse effects from leukotriene modifiers have prompted the FDA to further study and monitor montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

The adverse effects in surveillance include agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, and tremors.

The FDA has noted that doctors should consider discontinuing the drugs in patients who develop severe symptoms. The FDA made the following statement:

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks…The FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions. Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”


Please complete the form below for a FREE consultation.

  • This field is for validation purposes and should be left unchanged.


Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.


The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

attorney Joe Lyon reviews montelukast
A Voice for Those who have suffered

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.


  • This field is for validation purposes and should be left unchanged.

Questions about Montelukast Cases

Can I file a drug injury suit?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit.

Pharmaceutical litigation – through a lawsuit against a drug manufacturer – helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

Is there a lawsuit against Singulair?

Lawsuits have been filed against drug companies for failing to properly warn consumers for the potential for mental health side effects and depression related to the drug. 

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

Has Montelukast Been recalled?

The U.S. FDA warned consumers and health care professionals about a drug recall of one lot of Montelukast, inititated by Camber Pharmaceuticals, Inc.

How are the montelukast cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Is montelukast safe for long term use?

There are risks to taking any drug for long periods of time. Speak with your doctor about the benefits and risks, and call an attorney if you have experienced serious side effects. 

What are the side effects of taking montelukast?

The primary concern for healthcare professionals are the reported mental health side effects. 

Can montelukast cause psychosis?

Neuropsychiatric disorders related to montelukast have been reported in children and adults. Infants and children seem to be more prone to sleep trouble, and adolescents have presented with depression, anxiety and psychotic reactions.

Pharmaceutical Settlements

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against drug companies to obtain just compensation under the law. 


Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.


Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.