Additional adverse reactions of interest that occurred in <2% of ORALAIR recipients include dysphagia, nausea, vomiting, esophageal pain, gastritis, and gastroesophageal reflux.
Children and Adolescents
Overall, in placebo-controlled clinical trials, 154 children and adolescents 5 through 17 years of age received ORALAIR 300 IR, of whom 147 were exposed for more than 3 months. Of study participants, 66% were male, and 21% had a history of mild intermittent asthma at study entry. Data on race and ethnicity were not systematically captured.
The safety profile in the pediatric population, was generally similar to that of adults. In pediatric patients receiving ORALAIR, additional adverse reactions reported at an incidence of ≥2% and at a greater incidence than that in participants treated with placebo are listed in Table 3.
Table 3. Additional Adverse Reactions Reported by ≥2% of Children and Adolescents Receiving ORALAIR 300 IR and at a Greater Incidence than that in Participants Treated with Placebo 
Serious Adverse Reactions
At least 1 serious adverse event was reported in 22 of 1514 (1.5%) subjects who received ORALAIR at any dose, and 11 of 840 (1.1%) of placebo recipients. Of the 22 serious adverse events in the ORALAIR recipients, 2 were considered "definitely related" to ORALAIR.
The first subject was an adult who experienced a severe hypersensitivity reaction which began 5 minutes after administration of ORALAIR. The symptoms were violent coughing and marked dyspnea. The subject was treated with antihistamines, salbutamol and prednisolone and the reaction resolved without sequelae.
The second subject was an adult who experienced severe laryngeal edema. The subject was treated with prednisolone and event resolved without sequelae.
There was also one case of gastroenteritis with an onset on Day 93 of therapy that was possibly related to ORALAIR.
6.2 Postmarketing Experience
Post Marketing Safety Studies
A total of 1728 individuals (808 adults; 920 children 5 through 17 years of age) received ORALAIR in post marketing safety studies. Reported adverse reactions included: anaphylactic reaction, oral allergy syndrome, flushing, dyspnea, laryngeal edema, and diarrhea.
Spontaneous Postmarketing Reports
In addition to adverse reactions reported in clinical and post marketing safety studies, the following adverse reactions have been identified during post approval use of ORALAIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: autoimmune thyroiditis, eosinophilic myocarditis, eosinophilic esophagitis, palpitations, tachycardia, hypotension, loss of consciousness, circulatory collapse, malaise, pallor, peripheral vascular disorder, stridor, angioedema, face edema, weight decreased, wheezing, exacerbation of asthma, chest discomfort, oropharyngeal paresthesia, oropharyngeal blistering, headache, dizziness, tinnitus, asthenia, somnolence, anxiety, rash, pruritus, salivary gland enlargement and/or hypersecretion, dry mouth, dry eye, influenza-like syndrome, lymphadenopathy, eosinophil count increased.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B: Reproductive and developmental toxicity studies performed in fem