Ofev Side Effects

Summary of the safety profile: Nintedanib has been studied in clinical trials of 1529 patients suffering from Idiopathic Pulmonary Fibrosis (IPF).
The safety data provided in the following are based on the two Phase 3, randomised, double-blind, placebo-controlled studies in 1061 patients comparing treatment with nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2).
The most frequently reported adverse events associated with the use of nintedanib included diarrhoea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
For the management of selected adverse reactions please also refer to Precautions.
Tabulated list of adverse reactions: The table as follows provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.
Table 6 summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the postmarketing period.
Frequency categories are defined using the following convention: 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), not known (cannot be estimated from the available data).
Within each frequency grouping adverse reactions are presented in order of decreasing seriousness. (See Table 6.)


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