Odalade | Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Tabulated summary of reactions from clinical trials: Adverse drug reactions from clinical studies are listed as follows by MedDRA body system organ class and by frequency. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. The corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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). (See Tables 7, 8, 9, 10 and 11.)

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Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reactions have been reported during post-approval use of eltrombopag. Because they are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency, which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. (See Table 12.)

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Odalade Adverse Reactions

eltrombopag

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma