ADVERSE REACTIONS
Clinical Trial Experience
A total of 2446 patients were studied in premarketing clinical trials of butorphanol. Approximately half received STADOL Injection with the remainder receiving STADOL NS. In nearly all cases the type and incidence of side effects with butorphanol by any route were those commonly observed with opioid analgesics.
The adverse experiences described below are based on data from short-term and long-term clinical trials in patients receiving butorphanol by any route. There has been no attempt to correct for placebo effect or to subtract the frequencies reported by placebo-treated patients in controlled trials.
The most frequently reported adverse experiences across all clinical trials with STADOL Injection and STADOL NS were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). In long-term trials with STADOL NS only, nasal congestion (13%) and insomnia (11%) were frequently reported.
The following adverse experiences were reported at a frequency of 1% or greater in clinical trials and were considered to be probably related to the use of butorphanol.
Body as a Whole: asthenia/lethargy, headache, sensation of heat.
Cardiovascular: vasodilation, palpitations.
Digestive: anorexia, constipation, dry mouth, nausea and/or vomiting, stomach pain.
Nervous: anxiety, confusion, dizziness, euphoria, floating feeling, insomnia, nervousness, paresthesia, somnolence, tremor.
Respiratory: bronchitis, cough, dyspnea, epistaxis, nasal congestion, nasal irritation, pharyngitis, rhinitis, sinus congestion, sinusitis, upper respiratory infection.
Skin and Appendages: sweating/clammy, pruritus.
Special Senses: blurred vision, ear pain, tinnitus, unpleasant taste.
The following adverse experiences were reported with a frequency of less than 1% in clinical trials and were considered to be probably related to the use of butorphanol.
Cardiovascular: hypotension, syncope.
Nervous: abnormal dreams, agitation, dysphoria, hallucinations, hostility, withdrawal symptoms.
Skin and Appendages: rash/hives.
Urogenital: impaired urination.
The following infrequent additional adverse experiences were reported in a frequency of less than 1% of the patients studied in short-term STADOL NS trials and under circumstances where the association between these events and butorphanol administration is unknown. They are being listed as alerting information for the physician.
Body as a Whole: edema.
Cardiovascular: chest pain, hypertension, tachycardia.
Nervous: depression.
Respiratory: shallow breathing.
Postmarketing Experience
Postmarketing experience with STADOL NS and STADOL Injection has shown an adverse event profile similar to that seen during the premarketing evaluation of butorphanol by all routes of administration. Adverse experiences that were associated with the use of STADOL NS or STADOL Injection and that are not listed above have been chosen for inclusion below because of their seriousness, frequency of reporting, or probable relationship to butorphanol. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These adverse experiences include apnea, convulsion, delusion, drug dependence, excessive drug effect associated with transient difficulty speaking and/or executing purposeful movements, overdose, and vertigo. Reports of butorphanol overdose with a fatal outcome have usually but not always been associated with ingestion of multiple drugs.
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