Ilomedin 20 Adverse Reactions

Summary of the safety profile: The overall safety profile of Ilomedin is based on data from post-marketing surveillance and on pooled clinical trial data. The crude incidences were based on the cumulative database of 3325 patients having received iloprost either in controlled or uncontrolled clinical trials or in a compassionate use program from generally elderly and multimorbid patients with peripheral arterial occlusive disease (PAOD) in its advanced stages III and IV and patients with thromboangiitis obliterans (TAO), for details see Table 3.
The most frequently observed adverse drug reactions (≥10%) in patients receiving iloprost in clinical trials are headache, flushing, nausea, vomiting and hyperhidrosis. These are likely to occur while the dose is titrated at the start of treatment to identify the best tolerable dose for the individual patient. However, all these side effects usually disappear quickly with dose reduction.
Overall, the most serious adverse drug reactions in patients receiving iloprost are cerebrovascular accident, myocardial infarction, pulmonary embolism, cardiac failure, convulsion, hypotension, tachycardia, asthma, angina pectoris, dyspnea and pulmonary edema.
Another group of side effects is related to local infusion site reactions. For example, infusion site redness and infusion site pain may occur or a cutaneous vasodilation may give rise to streaky erythema above the infusion vein.
Tabulated list of adverse reactions: The adverse drug reactions observed with Ilomedin are represented in Table 3 as follows. They are classified according to System Organ Class. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Adverse drug reactions from clinical trials are classified according to their frequencies. Frequency groupings are defined according to the following convention: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1,000 to <1/100 and rare ≥1/10,000 to <1/1,000. (See Table 3.)

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Iloprost may provoke angina pectoris, especially in patients with coronary artery disease. The risk of bleeding is increased in patients when inhibitors of platelet aggregation, heparin or anticoagulants of the coumarin-type are given concomitantly.