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Aridol

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Aridol

Aridol

Aridol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aridol (mannitol) Inhalation Powder is a sugar alcohol indicated to assess bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma. Common side effects include severe bronchospasm in susceptible subjects, headache, throat irritation, nausea, cough, runny nose, shortness of breath, wheezing, chest pain, and dizziness.

Aridol is a test kit containing the required capsules of dry powder mannitol for oral inhalation in graduated doses with the supplied single patient use inhaler necessary to perform one bronchial challenge test. Aridol may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Aridol should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Aridol (mannitol) Inhalation Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aridol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Mannitol, the active ingredient in ARIDOL (mannitol inhalation powder) , is a sugar alcohol that may cause severe bronchospasm in susceptible subjects [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety population for the ARIDOL (mannitol inhalation powder) bronchial challenge test consisted of 1,082 subjects (577 females and 505 males) including patients with asthma, symptoms suggestive of asthma, and healthy individuals from 6 to 83 years of age who participated in the two clinical trials (Studies 1 and 2). The racial distribution of subjects was 84% Caucasian, 5 % Asian, 4 % Black, and 7 % Other. Children and adolescents comprised 23% of the total study population with 118 children aged 6-11 years and 128 adolescents aged 12-17 years.

Adverse reactions were reported at the time of the testing procedure and for one day thereafter. No serious adverse reactions were reported following bronchial challenge testing with ARIDOL (mannitol inhalation powder) in either trial.

Five adult subjects (0.6%) discontinued from the studies within a day following bronchial challenge testing with ARIDOL (mannitol inhalation powder) because of cough, decreased lung function, feeling jittery, sore throat, and throat irritation. One adult subject (0.3%) discontinued following the methacholine bronchial challenge test because of dizziness. One pediatric subject (0.4%) discontinued from the studies within a day following bronchial challenge testing with ARIDOL (mannitol inhalation powder) because of retching.

Table 2 displays the combined common adverse reactions ( ≥ 1%) within a day after bronchial challenge testing with ARIDOL (mannitol inhalation powder) or methacholine in the overall population for Studies 1 and 2.

Table 2: Adverse reactions with an incidence ≥ 1% within a day after bronchial challenge testing (overall population, Studies 1 and 2 combined)

Adverse Reactions Treatment
ARIDOL (mannitol inhalation powder)
(N=1046)
n (%)
Methacholine Challenge
(N=420)
n (%)
Headache 59 (6) 4 (1)
Pharyngolaryngeal pain 25 (2) 0
Throat irritation 19 (2) 1 ( < 1)
Nausea 19 (2) 0
Cough 17 (2) 8 (2)
Rhinorrhea 16 (2) 0
Dyspnea 15 (1) 21 (5)
Chest discomfort 13 (1) 18 (4)
Wheezing 8 (1) 6 (1)
Retching 6 (1) 0
Dizziness 5 (1) 13 (3)

The maximum reduction in FEV1 following bronchial challenge testing with ARIDOL (mannitol inhalation powder) was 46%, compared to 54% for exercise testing and 67% for the methacholine challenge. The incidences in decreases in FEV1 ≥ 30% and ≥ 60% following ARIDOL (mannitol inhalation powder) , methacholine, and exercise challenges for Studies 1 and 2 is shown in Table 3.

Table 3: Incidence of decreases in FEV1 ≥ 30% or ≥ 60% (overall population, Studies 1 and 2)

Challenge No. Exposed N (%) with Fall in FEV1 ≥ 30% N (%) with Fall in FEV1 ≥ 60%
Study 1
  Exercise 435 27 (6%) 0
  Methacholine 420 51 (12%) 3 (1%)
  ARIDOL 419 3 (1%) 0
Study 2
  ARIDOL asthmatics 536 23 (4%) 0
  ARIDOL Non-asthmatics 91 0 0

There were no differences in the incidence of adverse reactions based on gender or race. The clinical trials did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently compared to subjects below 65 years of age.

Children and Adolescent Aged 6 to 17 Years

Overall, the types and severities of adverse reactions in children were similar to those observed in the adult population. As in the adult population, the adverse reactions of pharyngolaryngeal pain, nausea, and headache were the more common with incidences of 4%, 3%, and 3%, respectively. There were no major differences in the types of adverse reactions observed in children 6-11 years of age compared to adolescents 12-17 years old.

The decrease in FEV1 in children and adolescents who received the ARIDOL (mannitol inhalation powder) bronchial challenge test was similar to that of the adult population with 5%, 15% and 9% of pediatric subjects who had bronchial challenge testing with ARIDOL (mannitol inhalation powder) , methacholine and exercise, respectively, experiencing reduction in FEV1 ≥ 30%. No patient who had bronchial challenge testing with ARIDOL (mannitol inhalation powder) or exercise had a decrease in FEV1 ≥ 60%, whereas, one adolescent patient (aged 12 years) who received methacholine had a decrease in FEV1 ≥ 60%.

Post-Marketing Experience

The following adverse reactions have been identified post approval outside the U.S. of the ARIDOL (mannitol inhalation powder) bronchial challenge test kit: cough, gagging, wheeze, and decreased forced expiratory volume. 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.

Read the entire FDA prescribing information for Aridol (Mannitol Inhalation Powder) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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