Nalbuphine Side Effects

Brand Names: Nubain

Please note - some side effects for Nalbuphine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nalbuphine - for the Consumer

Nalbuphine

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 Nalbuphine:

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

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.

Nalbuphine Side Effects - for the Professional

Nalbuphine

The most frequent adverse reaction in 1066 patients treated with Nalbuphine hydrochloride injection 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 Nalbuphine Hydrochloride Injection

Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for Nalbuphine hydrochloride injection: 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 Nalbuphine hydrochloride treatment. Fetal death has been reported where mothers received Nalbuphine hydrochloride during labor and delivery.

Side Effects by Body System

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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