Applies to nalbuphine: injection solution.
Warning
Injection route (Solution)
Serious, life-threatening, or fatal respiratory depression may occur with use of nalbuphine, particularly when used concomitantly with other opioids or central nervous system depressants. Monitor for respiratory depression, especially during initiation of nalbuphine or following a dose increase. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of nalbuphine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Serious side effects of Nalbuphine
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 with 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
- 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 the legs, arms, hands, or feet
- sleepiness or unusual drowsiness
- stomach pain
- sudden loss of consciousness
- swelling in the legs and ankles
- trembling or shaking of the hands or feet
Other side effects of Nalbuphine
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
- Dry mouth
- Headache
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 suddenly from a lying or sitting position
- 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, itching skin, rash
- indigestion
- irritability
- lack of appetite
- loss of interest or pleasure
- numbness
- pounding in the ears
- restlessness
- slow or fast heartbeat
- stomach discomfort or upset
- tiredness
- trouble concentrating
- trouble sleeping
- tingling feeling of unreality
- unusual tiredness or weakness
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection 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
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]
Frequency not reported: Anaphylactic/anaphylactoid, other serious hypersensitivity reactions and other allergic type reactions.[Ref]
Respiratory
Frequency not reported: Depression, dyspnea, asthma[Ref]
Depression, dyspnea, and asthma have been reported in less than 1% of patients.[Ref]
Cardiovascular
Frequency not reported: Hypertension, hypotension, bradycardia, tachycardia, fetal death[Ref]
Hypertension, hypotension, bradycardia, and tachycardia have been reported in less than 1% of patients.[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
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.
Frequency not reported: Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, dysphoria, unreality
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
Itching, burning, and urticaria have been reported in less than 1% of patients.[Ref]
Common (1% to 10%): Sweaty/clammy
Frequency not reported: Itching, burning, urticaria[Ref]
Other
Common (1% to 10%): Vertigo
Frequency not reported: Speech difficulty, flushing and warmth[Ref]
Speech difficulty, flushing and warmth have been reported in less than 1% of patients.[Ref]
Ocular
Blurred vision has been reported in less than 1% of patients.[Ref]
Frequency not reported: Blurred vision[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
