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Perforomist (Formoterol Fumarate Inhalation) - Side Effects and Adverse Reactions

Perforomist Rx
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ADVERSE REACTIONS

Long acting beta2-adrenergic agonists such as formoterol may increase the risk of asthma-related death [See BOXED 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 ReactionPERFOROMIST
Inhalation Solution
20 mcg		Placebo
n(%)n(%)
Total Patients123(100)114(100)
Diarrhea6(4.9)4(3.5)
Nausea6(4.9)3(2.6)
Nasopharyngitis4(3.3)2(1.8)
Dry Mouth4(3.3)2(1.8)
Vomiting3(2.4)2(1.8)
Dizziness3(2.4)1(0.9)
Insomnia3(2.4)00

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.



REPORTS OF SUSPECTED PERFOROMIST SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Perforomist. The information is not vetted and should not be considered as verified clinical evidence.

Possible Perforomist side effects / adverse reactions in 60 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-07

Patient: 60 year old female weighing 65.8 kg (144.7 pounds)

Reactions: Paranasal Sinus Discomfort, Wheezing, Rhinorrhoea, Ocular Discomfort, Lacrimation Increased, Nasal Septum Perforation, Epistaxis

Adverse event resulted in: disablity

Suspect drug(s):
Perforomist
    Dosage: 20mcg/2ml vial, twice daily, in nebulizer
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-06-01
    End date: 2012-01-01

Perforomist
    Dosage: 20mcg/2ml vial, twice daily, in nebulizer
    Indication: Dyspnoea
    Start date: 2011-06-01
    End date: 2012-01-01


Possible Perforomist side effects / adverse reactions in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: 79 year old male weighing 83.9 kg (184.6 pounds)

Reactions: Dizziness

Suspect drug(s):
Perforomist

Other drugs received by patient: Albuterol; Proton Pump Inhibitors; Spiriva; Blood Pressure Medication


Possible Perforomist side effects / adverse reactions in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: 62 year old male weighing 51.3 kg (112.8 pounds)

Reactions: Malaise, Haemoptysis

Suspect drug(s):
Perforomist

Other drugs received by patient: Xanax; Spiriva


See index of all Perforomist side effect reports >>
Drug label data at the top of this Page last updated: 2007-05-11

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