Nubain Side Effects

Generic Name: nalbuphine

Please note - some side effects for Nubain may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Nubain - for the Consumer

Nubain

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nubain:

Constipation; dizziness; drowsiness; dry mouth; feeling of a whirling motion; headache; nausea; sweating/clammy skin; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Nubain:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fainting; numbness of an arm or leg; seizures; severe headache, dizziness, or vomiting; slow heartbeat; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nubain Side Effects - for the Professional

Nubain

The most frequent adverse reaction in 1066 patients treated in clinical studies with Nubain was sedation 381 (36%).

Less frequent reactions were: sweaty/clammy 99 (9%), nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44 (4%), and headache 27 (3%).

Other adverse reactions which occurred (reported incidence of 1% or less) were:

CNS Effects

Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, confusion, faintness, hallucinations, dysphoria, feeling of heaviness, numbness, tingling, unreality. The incidence of psychotomimetic effects, such as unreality, depersonalization, delusions, dysphoria and hallucinations has been shown to be less than that which occurs with pentazocine.

Cardiovascular

Hypertension, hypotension, bradycardia, tachycardia.

Gastrointestinal

Cramps, dyspepsia, bitter taste.

Respiratory

Depression, dyspnea, asthma.

Dermatologic

Itching, burning, urticaria.

Miscellaneous

Speech difficulty, urinary urgency, blurred vision, flushing and warmth.

Allergic Reactions

Anaphylactic/anaphylactoid and other serious hypersensitivity reactions have been reported following the use of nalbuphine and may require immediate, supportive medical treatment. These reactions may include shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, or laryngeal edema. Some of these allergic reactions may be life-threatening. Other allergic-type reactions reported include stridor, bronchospasm, wheezing, edema, rash, pruritus, nausea, vomiting, diaphoresis, weakness, and shakiness.

Events Observed during Post-marketing Surveillance of Nubain

Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for Nubain: abdominal pain, pyrexia, depressed level or loss of consciousness, somnolence, tremor, anxiety, pulmonary edema, agitation, seizures, and injection site reactions such as pain, swelling, redness, burning, and hot sensations. Death has been reported from severe allergic reactions to Nubain treatment. Fetal death has been reported where mothers received Nubain during labor and delivery.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have frequently included sedation (36%), dizziness/vertigo (5%), and headache (3%). Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, confusion, faintness, hallucinations, dysphoria, feeling of heaviness, numbness, tingling, and unreality have been reported in less than 1% of patients. A depressed level of consciousness, somnolence, tremor, anxiety, agitation. and seizures have also been reported.

Cardiovascular

Cardiovascular side effects have included hypertension, hypotension, bradycardia, and tachycardia.

Gastrointestinal

Gastrointestinal side effects have frequently included nausea/vomiting (6%) and dry mouth (4%). Cramps, dyspepsia, and bitter taste have been reported in less than 1% of patients.

Respiratory

Respiratory side effects have included respiratory depression, dyspnea, asthma, and pulmonary edema.

Dermatologic

Dermatologic side effects have included itching, burning, and urticaria.

Other

Other side effects have frequently included a sweaty/clammy feeling (9%). Speech difficulty and flushing/warmth have been reported in less than 1% of patients.

Genitourinary

Genitourinary side effects have included urinary urgency.

Ocular

Ocular side effects have included blurred vision.

Hypersensitivity

Hypersensitivity reactions have included anaphylactic/anaphylactoid reactions including shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, and laryngeal edema. Some of these allergic reactions may be life-threatening. Death has been reported following severe allergic reactions to nalbuphine. Stridor, bronchospasm, wheezing, edema, rash, pruritus, nausea, vomiting, diaphoresis, weakness, and shakiness have also been reported.

Local

Local side effects have included pain, swelling, redness, burning, and hot sensations at the site of injection.

General

General side effects including abdominal pain and pyrexia have been reported.

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