Spiolto Respimat Side Effects

The safety of SPIOLTO RESPIMAT has been evaluated in active-controlled, parallel-group and cross-over clinical trials in overall 7,151 patients with COPD. A total of 1,988 patients with COPD received the target dose of 5 microgram tiotropium and 5 microgram olodaterol.
Side effects of SPIOLTO RESPIMAT were primarily identified from data obtained in 2 active controlled, parallel-group, long-term treatment (52 weeks) clinical trials in COPD patients.
In the pooled analysis of these long-term clinical trials the overall incidence of adverse events in patients treated with SPIOLTO RESPIMAT was comparable to patients treated with the mono components tiotropium at a dose of 5 microgram or olodaterol at a dose of 5 microgram (74%, 73.3% and 76.6%, respectively). All undesirable effects previously reported with one of the individual components are considered undesirable effects with SPIOLTO RESPIMAT and are included in the adverse reactions listed as follows.
Table 10 shows all adverse events that occurred with an incidence of >2% with SPIOLTO RESPIMAT treatment group and a higher incidence rate than the active comparator groups listed. The rates are derived from all reported adverse events of that type, regardless if considered drug-related or not by the clinical investigator. (See Table 10).


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Adverse reactions reported in all clinical trials with SPIOLTO RESPIMAT with a frequency of less than 2% are shown as follows according to system organ class. These also include all adverse reactions previously reported with one of the individual components.
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).
Infections and infestations: Rare: nasopharyngitis.
Metabolism and nutrition disorders: Not known: dehydration.
Nervous system disorders: Uncommon: dizziness, insomnia.
Eye disorders: Rare: vision blurred.
Not known: glaucoma, intraocular pressure increased.
Cardiac disorders: Uncommon: atrial fibrillation, palpitations, tachycardia.
Rare: supraventricular tachycardia.
Vascular disorders: Uncommon: hypertension.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Rare: epistaxis, pharyngitis, dysphonia, laryngitis.
Not known: bronchospasm, sinusitis.
Gastrointestinal disorders: Common: dry mouth.
Uncommon: constipation.
Rare: oropharyngeal candidiasis, gingivitis.
Not known: dysphagia, gastro-oesophageal reflux disease, glossitis, stomatitis, intestinal obstruction incl. ileus paralytic.
Skin and subcutaneous disorders: Rare: pruritus, angioneurotic oedema, urticaria, hypersensitivity (including immediate reactions).
Not known: rash, skin infection and skin ulcer, dry skin.
Musculoskeletal and connective tissue disorders: Rare: back pain¹, arthralgia.
Not known: joint swelling.
Renal and urinary disorders: Rare: urinary retention (usually in men with predisposing factors), dysuria.
Not known: urinary tract infection.
¹ Undesirable effects reported with SPIOLTO RESPIMAT, but not with the individual components.
Many of the listed adverse effects can be assigned to either the anticholinergic properties of tiotropium or to the β-adrenergic properties of olodaterol, the components of SPIOLTO RESPIMAT.
In addition the occurrence of other undesirable effects related to the beta-adrenergic agonist class, which are not listed previously, should be taken into consideration, such as arrhythmia, myocardial ischaemia, angina pectoris, hypotension, tremor, headache, nervousness, nausea, muscle spasms, fatigue, malaise, hypokalaemia, hyperglycaemia, and metabolic acidosis.