Stadol Side Effects

Generic name: butorphanol

Note: This document contains side effect information about butorphanol. Some of the dosage forms listed on this page may not apply to the brand name Stadol.

Some side effects of Stadol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to butorphanol: nasal spray

Get emergency medical help if you have any of these signs of an allergic reaction while taking butorphanol (the active ingredient contained in Stadol) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using butorphanol nasal and call your doctor at once if you have a serious side effect such as:

• pounding or uneven heartbeats;

• shallow breathing, slow heartbeat;

• cold, clammy skin;

• problems with urination;

• tremors, numbness or tingling;

• confusion, feeling like you are floating;

• feeling like you might pass out; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects include:

• drowsiness, dizziness;

• nosebleed, stuffy nose, cough;

• sleep problems (insomnia);

• constipation;

• nausea, vomiting, loss of appetite;

• flushing (warmth, redness, or tingly feeling);

• dry mouth, unpleasant taste; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to butorphanol: injectable solution, nasal spray

Other

The manufacturer has reported that in clinical trials (n=2,446), approximately half of the patients received butorphanol (the active ingredient contained in Stadol) injection and the other half received butorphanol nasal spray. The type and incidence of side effects with butorphanol by either route were consistent with those commonly found with opioid analgesics.

Nervous system

Nervous system effects including somnolence (43%), dizziness (19%), insomnia (11%), anxiety, confusion, euphoria, floating feeling, nervousness, paresthesia, and tremor have been reported.

Respiratory

Respiratory effects including nasal congestion (13%), bronchitis, cough, dyspnea, epistaxis, nasal irritation, pharyngitis, rhinitis, sinus congestion, sinusitis, and upper respiratory infection have all been predominantly reported from long term trials with butorphanol (the active ingredient contained in Stadol) nasal spray.

Gastrointestinal

Gastrointestinal effects including nausea and/or vomiting (13%), anorexia, constipation, dry mouth, and stomach pain have been reported.

General

Asthenia/lethargy, headache, and a sensation of heat have been reported.

Cardiovascular

Cardiovascular effects including vasodilation and palpitations have been predominantly reported from long term trials with butorphanol (the active ingredient contained in Stadol) nasal spray.

Dermatologic

Dermatologic effects including sweating/clammy skin and pruritus have been reported.

Other

Ear pain, tinnitus, and unpleasant taste have been predominantly reported from trials with butorphanol (the active ingredient contained in Stadol) nasal spray.

Ocular

Ocular effects including blurred vision have been reported.

Musculoskeletal

Musculoskeletal effects including a case of fibrous myopathy have been reported in a patient abusing intramuscular butorphanol (the active ingredient contained in Stadol)

Other

Elderly patients may be more sensitive to the effects of butorphanol (the active ingredient contained in Stadol) Clinical studies of butorphanol administered via the intranasal route have reported that elderly patients had an increased frequency of headache, dizziness, drowsiness, vertigo, constipation, nausea and/or vomiting, and nasal congestion, compared with younger patients.

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