Abstral Adverse Reactions

Undesirable effects typical of opioids are to be expected with Abstral; they tend to decrease in intensity with continued use. The most serious potential adverse reactions associated with opioid use are respiratory depression (which could lead to respiratory arrest), hypotension and shock.
The clinical trials of Abstral were designed to evaluate safety and efficacy in treating patients with breakthrough cancer pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain. Therefore it is not possible to definitively separate the effects of Abstral alone.
The most frequently observed adverse reactions with Abstral include typical opioid adverse reactions, such as nausea, constipation, somnolence and headache.
Tabulated Summary of Adverse Reactions with Abstral and/or Other Fentanyl-Containing Compounds: The following adverse reactions have been reported with Abstral and/or other fentanyl-containing compounds during clinical studies and from post-marketing experience. They are listed as follows by system organ class and frequency [very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; not known (cannot be estimated from available data)]. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 2.)

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