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Nalbuphine Side Effects

For the Consumer

Applies to nalbuphine: injection solution

Along with its needed effects, nalbuphine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking nalbuphine:

Rare

  • Chest pain or discomfort
  • difficult or labored breathing
  • difficulty swallowing
  • fainting
  • false beliefs that cannot be changed by facts
  • fast, pounding, or irregular heartbeat or pulse
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • redness of the face, neck, arms and occasionally, upper chest
  • seeing, hearing, or feeling things that are not there
  • sense of detachment from self or body
  • shortness of breath
  • slow or irregular heartbeat

Incidence Not Known

  • Blue lips and fingernails
  • convulsions
  • coughing that sometimes produces a pink frothy sputum
  • decrease in consciousness
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • fear or nervousness
  • fever
  • hyperventilation
  • increased sweating
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • pale skin
  • shakiness in legs, arms, hands, or feet
  • sleepiness or unusual drowsiness
  • stomach pain
  • sudden loss of consciousness
  • swelling in legs and ankles
  • trembling or shaking of hands or feet

Some side effects of nalbuphine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Dizziness or lightheadedness
  • drowsiness
  • feeling of constant movement of self or surroundings
  • nausea
  • relaxed and calm
  • sensation of spinning
  • sleepiness
  • sweaty, clammy skin
  • vomiting

Less Common

Rare

  • Acid or sour stomach
  • aggressive or angry
  • belching
  • blurred vision
  • burning
  • changes in speech
  • confusion
  • cough
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • dysphoria
  • excessive crying
  • false or unusual sense of well-being
  • feeling of heaviness
  • feeling of warmth
  • feeling sad or empty
  • floating feeling
  • frequent strong or increased urge to urinate
  • headache
  • heartburn
  • hives or welts
  • indigestion
  • irritability
  • itching of skin
  • lack of appetite
  • loss of interest or pleasure
  • nervousness
  • numbness
  • pounding in the ears
  • restlessness
  • skin rash
  • slow or fast heartbeat
  • stomach discomfort, upset, or pain
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • tingling feeling of unreality
  • unusual tiredness or weakness

Incidence Not Known

  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

For Healthcare Professionals

Applies to nalbuphine: compounding powder, injectable solution

General

The most commonly reported adverse reaction is sedation. Less frequently reported events have included sweaty/clammy, nausea/vomiting, dizziness/vertigo, dry mouth, and headache.[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic/anaphylactoid, other serious hypersensitivity reactions and other allergic type reactions.[Ref]

Anaphylactic/anaphylactoid and other serious hypersensitivity reactions, including fatalities have been reported. Serious allergic reactions may include shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, or laryngeal edema. Other allergic type reactions reported have include stridor, bronchospasm, wheezing, edema, rash, pruritus, nausea, vomiting, diaphoresis, weakness, and shakiness.[Ref]

Respiratory

Depression, dyspnea, and asthma have been reported in less than 1% of patients.[Ref]

Frequency not reported: Depression, dyspnea, asthma[Ref]

Cardiovascular

Hypertension, hypotension, bradycardia, and tachycardia have been reported in less than 1% of patients.[Ref]

Frequency not reported: Hypertension, hypotension, bradycardia, tachycardia, fetal death[Ref]

Nervous system

Confusion, faintness, numbness, and tingling have been reported in less than 1%. Postmarketing reports of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Very common (10% or more): Sedation (36%)

Common (1% to 10%): Dizziness, headache

Frequency not reported: Confusion, faintness, numbness, tingling

Postmarketing reports: Serotonin syndrome[Ref]

Psychiatric

Frequency not reported: Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, dysphoria, unreality

Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, dysphoria, and unreality have been reported in less than 1% of patients. The incidence of psychotomimetic effects has been reported to be less than that which occur with pentazocine.

Gastrointestinal

Cramps, dyspepsia, and bitter taste have been reported in less than 1% of patients.[Ref]

Common (1% to 10%): Nausea/vomiting, dry mouth

Frequency not reported: Cramps, dyspepsia, bitter taste[Ref]

Dermatologic

Common (1% to 10%): Sweaty/clammy

Frequency not reported: Itching, burning, urticaria[Ref]

Itching, burning, and urticaria have been reported in less than 1% of patients.[Ref]

Other

Speech difficulty, flushing and warmth have been reported in less than 1% of patients.[Ref]

Common (1% to 10%): Vertigo

Frequency not reported: Speech difficulty, flushing and warmth[Ref]

Ocular

Frequency not reported: Blurred vision[Ref]

Blurred vision has been reported in less than 1% of patients.[Ref]

Genitourinary

Frequency not reported: Urinary urgency[Ref]

Urinary urgency has been reported in less than 1% of patients.[Ref]

Endocrine

There have been postmarketing reports of adrenal insufficiency in patients taking opioids, generally for longer than 1 month.

Postmarketing reports: Adrenal insufficiency

References

1. "Product Information. Nubain (nalbuphine)." Endo Laboratories, Texarkana, TX.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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