PERFOROMIST SIDE EFFECTS
- Generic Name: formoterol fumarate inhalation solution
- Brand Name: Perforomist
- Drug Class: Beta2 Agonists
SIDE EFFECTS
Long-acting beta2 -adrenergic agonists such as formoterol increase the risk of asthma-related death [see BOX WARNING and WARNINGS AND PRECAUTIONS].
Beta2 -Agonist Adverse Reaction Profile
Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.
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.
Adults With COPD
The data described below reflect exposure to PERFOROMIST Inhalation Solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. PERFOROMIST Inhalation Solution was studied in a 12-week, placebo- and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). Patients were mostly Caucasians (88%) between 40-90 years old (mean, 64 years old) and had COPD, with a mean FEV1 of 1.33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.
Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the PERFOROMIST Inhalation Solution group and where the rate in the PERFOROMIST Inhalation Solution group exceeded the rate in the placebo group. In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for PERFOROMIST Inhalation Solution and 4.4% for placebo. There were no frequently occurring specific cardiovascular adverse events for PERFOROMIST Inhalation Solution (frequency greater than or equal to 1% and greater than placebo). The rate of COPD exacerbations was 4.1% for PERFOROMIST Inhalation Solution and 7.9% for placebo.
TABLE 1: Number of patients with adverse reactions in the 12-week multiple-dose controlled clinical trial
| Adverse Reaction | PERFOROMIST Inhalation Solution 20 mcg |
Placebo | ||
| n | (%) | n | (%) | |
| Total Patients | 123 | (100) | 114 | (100) |
| Diarrhea | 6 | (4.9) | 4 | (3.5) |
| Nausea | 6 | (4.9) | 3 | (2.6) |
| Nasopharyngitis | 4 | (3.3) | 2 | (1.8) |
| Dry Mouth | 4 | (3.3) | 2 | (1.8) |
| Vomiting | 3 | (2.4) | 2 | (1.8) |
| Dizziness | 3 | (2.4) | 1 | (0.9) |
| Insomnia | 3 | (2.4) | 0 | 0 |
Patients treated with PERFOROMIST Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of PERFOROMIST Inhalation Solution. 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.
Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm
SRC: NLM .