"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
Stadol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Stadol (butorphanol tartrate) is used to treat moderate to severe pain. It is also used as part of anesthesia for surgery, or during early labor (if childbirth is expected to be more than 4 hours away). Stadol is no longer manufactured and can only be found in its generic form of butorphanol. Butorphanol is a narcotic pain reliever, similar to morphine. Butorphanol causes many side effects. Tell your doctor if you have any of these serious side effects: palpitations, increased blood pressure, shallow breathing, clammy skin, tremors, or confusion. If you have any symptoms of an allergic reaction (hives, difficulty breathing, swelling of the face) seek emergency treatment immediately. Other side effects may occur. Tell your doctor about any side effects.
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. Do not use butorphanol with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can cause sleepiness or slow your breathing. 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. This medication may be habit forming. Do not stop using butorphanol suddenly, or you could have withdrawal symptoms.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Stadol in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have any of these serious side effects:
- pounding, or uneven heartbeats;
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
- shallow breathing, slow heartbeat;
- cold, clammy skin;
- problems with urination;
- confusion, feeling like you are floating; or
- feeling light-headed, fainting.
Less serious side effects include:
- drowsiness, dizziness;
- nausea, vomiting, loss of appetite;
- warmth or redness under the skin;
- dry mouth;
- blurred vision;
- ringing in your ear;
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Stadol (Butorphanol Tartrate) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Stadol FDA Prescribing Information: Side Effects
Clinical Trial Experience
A total of 2446 patients were studied in premarketing clinical trials of butorphanol. Approximately half received STADOL (butorphanol tartrate) Injection with the remainder receiving STADOL (butorphanol tartrate) 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 (butorphanol tartrate) Injection and STADOL (butorphanol tartrate) NS were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%). In long-term trials with STADOL (butorphanol tartrate) 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.
Skin and Appendages: sweating/clammy, pruritus.
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.
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 (butorphanol tartrate) 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.
Respiratory: shallow breathing.
Postmarketing experience with STADOL (butorphanol tartrate) NS and STADOL (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 STADOL (butorphanol tartrate) NS or STADOL (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.
Drug Abuse And Dependence
STADOL (butorphanol tartrate) Injection and STADOL NS (butorphanol tartrate) Nasal Spray are 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.
Clinical Trial Experience
In all clinical trials, less than 1% of patients using STADOL (butorphanol tartrate) NS 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 STADOL (butorphanol tartrate) NS. However, in one controlled clinical trial where patients with chronic pain from nonmalignant disease were treated with STADOL (butorphanol tartrate) NS (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 STADOL (butorphanol tartrate) NS and no patients receiving placebo. Probable withdrawal symptoms were reported in eight (2.6%) patients using STADOL (butorphanol tartrate) NS and no patients receiving placebo in the chronic nonmalignant pain study. Most of these patients abruptly discontinued STADOL (butorphanol tartrate) NS after extended use or high doses. Symptoms suggestive of withdrawal included anxiety, agitation, tremulousness, diarrhea, chills, sweats, insomnia, confusion, incoordination, and hallucinations.
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) »
Additional Stadol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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