Nalbuphine Side Effects

Some side effects of nalbuphine 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 nalbuphine: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking nalbuphine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• weak or shallow breathing;

• fast or slow heart rate;

• cold, clammy skin;

• confusion, hallucinations, unusual thoughts or behavior;

• severe weakness or drowsiness; or

• feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

• feeling nervous or restless;

• depression;

• strange dreams;

• stomach pain, upset stomach;

• bitter taste in your mouth;

• skin itching or burning, mild rash;

• blurred vision, slurred speech; or

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

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 nalbuphine: compounding powder, injectable solution

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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