Fentanyl-Piramal Adverse Reactions



Piramal Critical Care


Evercare Pharma
Full Prescribing Info
Adverse Reactions
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of fentanyl citrate based on the comprehensive assessment of the available adverse event information. A causal relationship with fentanyl citrate cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical trial data: The safety of FENTANYL was evaluated in 376 subjects who participated in 20 clinical trials evaluating FENTANYL used as an anesthetic. These subjects took at least one dose of FENTANYL and provided safety data. Adverse reactions, as identified by the investigator, reported for ≥1% of FENTANYL-treated subjects in these studies are shown in Table 1. (See Table 1.)

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Additional adverse reactions that occurred in <1% of FENTANYL-treated subjects in the 20 clinical trials are listed as follows in Table 2. (See Table 2.)

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Postmarketing data: Adverse reactions first identified during postmarketing experience with FENTANYL are included in Table 3. In this table, the frequencies are provided according to the following convention: Very common ≥ 1/10, Common ≥ 1/100 and < 1/10, Uncommon ≥ 1/1000 and < 1/100, Rare ≥ 1/10000 and < 1/1000, Very rare < 1/10000, including isolated reports.
In Table 3, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 3.)

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When a neuroleptic is used with FENTANYL, the following adverse reactions may be observed: chills and/or shivering; restlessness, post-operative hallucinatory episodes; and extrapyramidal symptoms (see Precautions).
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