Common side effects include diarrhea, nausea, vomiting, mild rashes, asymptomatic elevations in liver enzymes, and fever. Uncommon side effects include fatigue and malaise, behavioral changes, paresthesias and seizures, muscle cramps, and nose bleeds. Rare (may affect up to 1 in 10,000 people taking<unk>  but serious side effects include behavioral changes (including suicidal thoughts), angioedema, erythema multiforme, and liver problems. In 2019 and 2020, concerns for neuropsychiatric reactions were added to the label in the United Kingdom and United States where the most frequently suspected were nightmares, depression, insomnia (may affect between 1 in 100 to 1 in 1,000 people taking<unk> ; aggression, anxiety and abnormal behaviour or changes in behaviour (may affect between 1 in 1,000 and 1 in 10,000 people taking<unk> . FDA investigation In June 2009, the U.S. Food and Drug Administration (FDA) concluded a review into the possibility of neuropsychiatric side effects with leukotriene modulator drugs. Although clinical trials only revealed an increased risk of insomnia, post-marketing surveillance showed that the drugs are associated with a possible increase in suicidal behavior and other side effects such as agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, irritability, restlessness, and tremor. In September 2019, the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee met to discuss a pediatric-focused safety review of neuropsychiatric events with<unk> . In March 2020, the FDA required a boxed warning for<unk>  to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug in the wake of an increase in case reporting of neuropsychiatric events around the time of the initial communications about the concern from FDA in 2008. The boxed warning advises health care providers to avoid prescribing<unk>  for people with mild symptoms, particularly those with allergic rhinitis because there are many other effective, less-concerned allergy medicines that are also indicated for the mild cases. In the FDA's self-conducted data analysis in comparison to their received case reports which were dependent on people's self-claims, the propensity of developing neuropsychiatric disorders after<unk>  use does not outpace that of inhaled corticosteroids; and there were no statistically significant risks of new-onset neuropsychiatric disorders among males, females, patients 12 years and older, patients with a psychiatric history, or after the 2008 FDA communication and prescribing information changes that first publicized the concern. In addition, FDA's self-conducted data analysis also summarized their own findings, saying "exposure to<unk>  was significantly associated with a decreased risk of treated outpatient depressive disorder and the decreased risks were seen among patients with a history of a psychiatric disorder, in patients 12 to 17 years as well as 18 years and older, and in both females and males." "Treated outpatient depressive disorder" refers to patients' actions of making an appointment with psychiatrists to contend with their depressions.
Montelukast
Seratrodast
Pranlukast
Azelastine
Zafirlukast
Roxadustat
Allergan
Lifitegrast