Trimbow Adverse Reactions

Summary of the safety profile: The most frequently reported adverse reactions in patients with COPD or asthma are respectively: dysphonia (0.3% and 1.5%) and oral candidiasis (0.8% and 0.3%), which are normally associated with inhaled corticosteroids; muscle spasms (0.4% and 0.2%), which can be attributed to the long-acting beta2-agonist component; and dry mouth (0.4% and 0.5%), which is a typical anticholinergic effect.
In asthmatic patients, adverse reactions tend to cluster during the first 3 months following initiation of therapy and become less frequent with longer-term use (after 6 months of treatment).
Tabulated list of adverse reactions: Adverse reactions associated to beclometasone dipropionate/formoterol/glycopyrronium occurred during clinical studies and post-marketing experience as well as adverse reactions listed for the marketed individual components are provided as follows, listed by system organ class and frequency.
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 2.)

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Among the observed adverse reactions the following are typically associated with: Beclometasone dipropionate: Pneumonia, oral fungal infections, lower respiratory tract infection fungal, dysphonia, throat irritation, hyperglycemia, psychiatric disorders, cortisol decreased, blurred vision.
Formoterol: Hypokalemia, hyperglycemia, tremor, palpitations, muscle spasms, electrocardiogram QT prolonged, blood pressure increased, blood pressure decreased, atrial fibrillation, tachycardia, tachyarrhythmia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm.
Glycopyrronium: Glaucoma, atrial fibrillation, tachycardia, palpitations, dry mouth, dental caries, dysuria, urinary retention, urinary tract infection.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Patient should seek medical attention immediately at the first sign of any adverse drug reaction.