Comfora Adverse Reactions

Summary of the safety profile: The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium. The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications.
The most common adverse events reported from the clinical studies are headache, dizziness and gastrointestinal events like diarrhea, nausea, abdominal pain and rectal bleeding.
The adverse events reported under treatment with pentosan polysulfate sodium were comparable to those reported under treatment with placebo in regards to quality and quantity.
Tabulated summary of adverse events: Adverse events are listed as follows by MedDRA body system organ class and by frequency. 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 available data). (See table.)

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