A total of 1658 patients were studied in premarketing clinical trials of Butorphanol Tartrate Injection. In nearly all cases the type and incidence of side effects with butorphanol were those commonly observed with opioid analgesics.
The adverse experiences described below are based on data from short- and long-term clinical trials in patients receiving Butorphanol Tartrate Injection.
The most frequently reported adverse experiences across all clinical trials with Butorphanol Tartrate Injection and Nasal Spray were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). 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: Cough, Dyspnea
Skin and Appendages: Sweating, 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 butorphanol tartrate nasal sprays 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 due to their clinical significance:
Body as a Whole: Edema
Cardiovascular: Chest Pain, Hypertension, Tachycardia
Nervous: Depression
Respiratory: Shallow Breathing
The following adverse reactions have been identified during post approval use of Butorphanol Tartrate Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
A total of 1658 patients were studied in premarketing clinical trials of Butorphanol Tartrate Injection. In nearly all cases the type and incidence of side effects with butorphanol were those commonly observed with opioid analgesics.
The adverse experiences described below are based on data from short- and long-term clinical trials in patients receiving Butorphanol Tartrate Injection.
The most frequently reported adverse experiences across all clinical trials with Butorphanol Tartrate Injection and Nasal Spray were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). 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: Cough, Dyspnea
Skin and Appendages: Sweating, 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 butorphanol tartrate nasal sprays 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 due to their clinical significance:
Body as a Whole: Edema
Cardiovascular: Chest Pain, Hypertension, Tachycardia
Nervous: Depression
Respiratory: Shallow Breathing
The following adverse reactions have been identified during post approval use of Butorphanol Tartrate Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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FDA Medwatch
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