Stadol

Last updated on RxList: 3/22/2021
Stadol Side Effects Center

What Is Stadol?

Stadol (butorphanol tartrate) is a narcotic pain reliever, similar to morphine used to treat moderate to severe pain. Stadol is also used as part of anesthesia for surgery, or during early labor (if childbirth is expected to be more than 4 hours away). The brand name Stadol is no longer manufactured and can only be found in generic form.

What Are Side Effects of Stadol?

Common side effects of Stadol (butorphanol) include:

Tell your doctor if you have any serious side effects of Stadol (butorphanol) including:

If you have symptoms of an allergic reaction to Stadol (butorphanol) (hives, difficulty breathing, swelling of the face) seek emergency treatment immediately.

Dosage for Stadol

Butorphanol is given as an injection into a muscle or a vein. It is also available as a nasal spray. Dangerous side effects or death can occur when alcohol is combined with butorphanol.

What Drugs, Substances, or Supplements Interact with Stadol?

Do not use butorphanol with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can cause sleepiness or slow your breathing.

Stadol During Pregnancy and Breastfeeding

Butorphanol may be harmful to an unborn baby. Tell your doctor if you are pregnant. Butorphanol is sometimes used during early labor, but using it just before childbirth can cause breathing problems in a newborn. Butorphanol passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding. This medication may be habit forming. Do not stop using butorphanol suddenly, or you could have withdrawal symptoms.

Additional Information

Our Stadol (butorphanol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Stadol Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops;
  • a slow heart rate or weak pulse;
  • fast or pounding heartbeats;
  • problems with urination;
  • confusion, feeling like you are floating;
  • a light-headed feeling, like you might pass out; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects include:

  • nausea, vomiting;
  • drowsiness, dizziness;
  • dry mouth; or
  • warmth or redness under the skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Stadol (Butorphanol Tartrate)

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Stadol Professional Information

SIDE EFFECTS

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.

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 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.

Body as a Whole: edema

Cardiovascular: chest pain, hypertension, tachycardia

Nervous: depression

Respiratory: shallow breathing

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 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 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.

Read the entire FDA prescribing information for Stadol (Butorphanol Tartrate)

© Stadol Patient Information is supplied by Cerner Multum, Inc. and Stadol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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