Does Stadol (butorphanol) cause side effects?

Stadol (butorphanol) is a synthetic opioid narcotic pain reliever used to treat severe pain, for preoperative or preanesthetic pain management, and to manage pain during labor

Stadol prevents pain in a similar way as morphine, hydrocodone, oxycodone, and other opioids. 

Like other opioids, it stimulates receptors in the brain to increase the threshold to pain (the amount of stimulation it takes to feel pain) and reduce the perception of pain (the perceived importance of the pain). 

Common side effects of Stadol include

Serious side effects of Stadol include difficulty breathing. Stadol is habit forming. Mental and physical dependence can occur when used long-term.

Drug interactions of Stadol include other agents that cause depression of the central nervous system, because the combination may lead to increased sedation and confusion.

  • Alvimopan should not be combined with Stadol because it increases levels of Stadol.
  • Stadol should not be taken with any monoamine oxidase inhibitor (MAOI) antidepressants or other drugs that inhibit monoamine oxidase, for example, linezolid.
  • Such combinations may lead to confusion, high blood pressure, tremor, hyperactivity, coma, and death.
  • Stadol should not be administered within 14 days of stopping an MAOI. 

There are no adequate and well-controlled studies of Stadol in pregnant women before 37 weeks of gestation. Stadol should be used during pregnancy only if the potential benefit justifies the potential risk to the infant. 

Stadol is excreted in breast milk. The amount that the infant may receive is very low and insignificant. Consult your doctor before breastfeeding

What are the important side effects of Stadol (butorphanol)?

The most frequent adverse reactions include

Patients may also experience

Butorphanol is habit forming. Mental and physical dependence can occur when used long-term.

Stadol (butorphanol) side effects list for healthcare professionals

Clinical Trial Experience

A total of 2446 patients were studied in premarketing clinical trials of butorphanol. Approximately half received butorphanol tartrate injection with the remainder receiving butorphanol tartrate nasal spray. 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 butorphanol tartrate injection and butorphanol tartrate nasal spray were

  • somnolence (43%),
  • dizziness (19%),
  • nausea and/or vomiting (13%).

In long-term trials with butorphanol tartrate nasal spray 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.

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.

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 spray 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.

Postmarketing Experience

  • Postmarketing experience with butorphanol tartrate nasal spray and butorphanol tartrate 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 butorphanol tartrate nasal spray or butorphanol tartrate 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 the ingestion of multiple drugs.

Clinical Trial Experience

  • In all clinical trials, less than 1% of patients using butorphanol tartrate nasal spray had experiences that suggested the development of physical dependence or tolerance.
  • Much of this information is based on experience with patients who did not have prolonged continuous exposure to butorphanol tartrate nasal spray. However, in one controlled clinical trial where patients with chronic pain from the nonmalignant disease were treated with butorphanol tartrate nasal spray (n=303) or placebo (n=99) for up to 6 months, overuse (which may suggest the development of tolerance) was reported in nine (2.9%) patients receiving butorphanol tartrate nasal spray and no patients receiving placebo.
  • Probable withdrawal symptoms were reported in eight (2.6%) patients using butorphanol tartrate nasal spray and no patients receiving placebo in the chronic nonmalignant pain study.
  • Most of these patients abruptly discontinued butorphanol tartrate nasal spray after extended use or high doses. Symptoms suggestive of withdrawal included
    • anxiety,
    • agitation,
    • tremulousness,
    • diarrhea,
    • chills,
    • sweats,
    • insomnia,
    • confusion,
    • incoordination, and
    • hallucinations.

Postmarketing Experience

Butorphanol tartrate has been associated with episodes of abuse and dependence. Of the cases received, there were more reports of abuse with the nasal spray formulation than with the injectable formulation.

What drugs interact with Stadol (butorphanol)?

  • Concurrent use of butorphanol with central nervous system depressants (e.g., alcohol, barbiturates, tranquilizers, and antihistamines) may result in increased central nervous system depressant effects.
  • When used concurrently with such drugs, the dose of butorphanol should be the smallest effective dose and the frequency of dosing reduced as much as possible when administered concomitantly with drugs that potentiate the action of opioids.
  • In healthy volunteers, the pharmacokinetics of a 1 mg dose of butorphanol administered as butorphanol tartrate nasal spray were not affected by the coadministration of a single 6 mg subcutaneous dose of sumatriptan.
  • However, in another study in healthy volunteers, the pharmacokinetics of butorphanol were significantly altered (29% decrease in AUC and 38% decreases in Cmax) when a 1 mg dose of butorphanol tartrate nasal spray was administered 1 minute after a 20 mg dose of sumatriptan nasal spray. (The two drugs were administered in opposite nostrils.)
  • When the butorphanol tartrate nasal spray was administered 30 minutes after the sumatriptan nasal spray, the AUC of butorphanol increased 11% and Cmax decreased 18%.
  • In neither case were the pharmacokinetics of sumatriptan affected by coadministration with butorphanol tartrate nasal spray.
  • These results suggest that the analgesic effect of butorphanol tartrate nasal spray may be diminished when it is administered shortly after sumatriptan nasal spray, but by 30 minutes any such reduction in effect should be minimal.
  • The safety of using Butorphanol Tartrate Nasal Spray and IMITREX (sumatriptan) Nasal Spray during the same episode of migraine has not been established. However, it should be noted that both products are capable of producing transient increases in blood pressure.
  • The pharmacokinetics of a 1 mg dose of butorphanol administered as butorphanol tartrate nasal spray were not affected by the coadministration of cimetidine (300 mg QID).
  • Conversely, the administration of butorphanol tartrate nasal spray (1 mg butorphanol QID) did not alter the pharmacokinetics of a 300 mg dose of cimetidine.
  • It is not known if the effects of butorphanol are altered by concomitant medications that affect hepatic metabolism of drugs (erythromycin, theophylline, etc.), but physicians should be alert to the possibility that a smaller initial dose and longer intervals between doses may be needed.
  • The fraction of butorphanol tartrate nasal spray absorbed is unaffected by the concomitant administration of a nasal vasoconstrictor (oxymetazoline), but the rate of absorption is decreased. Therefore, a slower onset can be anticipated if butorphanol tartrate nasal spray is administered concomitantly with, or immediately following, a nasal vasoconstrictor.
  • No information is available about the use of butorphanol concurrently with MAO inhibitors.

Does Stadol (butorphanol) cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

  • Butorphanol tartrate nasal spray is listed in Schedule IV of the Controlled Substances Act (CSA).
  • Proper patient selection, dose and prescribing limitations, appropriate directions for use, and frequent monitoring are important to minimize the risk of abuse and physical dependence with butorphanol tartrate.
  • Special care should be exercised in administering butorphanol to patients with a history of drug abuse or to patients receiving the drug on a continuous basis for an extended period.

Summary

Stadol (butorphanol) is a synthetic opioid narcotic pain reliever used to treat severe pain, for preoperative or preanesthetic pain management, and to manage pain during labor. Common side effects of Stadol include drowsiness, dizziness, nausea, vomiting, nasal congestion and insomnia with the nasal preparation, palpitations, flushing, anxiety, confusion, euphoria, headache, nervousness, tingling sensation in limbs, cold/clammy skin, sweating, itchiness, loss of appetite, constipation, stomach pain, dry mouth, tremor, weakness, blurred vision, and ringing in the ears. Stadol should be used during pregnancy only if the potential benefit justifies the potential risk to the infant. Stadol is excreted in breast milk.

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Medically Reviewed on 1/25/2021
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.