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Nubain

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Nubain

Nubain

Nubain Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nubain (nalbuphine hydrochloride) is used to treat moderate to severe pain. It is also used for treating pain just after surgery or childbirth. It is a narcotic pain reliever. Common side effects include warmth, tingling, or redness under your skin, nausea, vomiting, stomach cramps, dizziness, spinning sensation, dry mouth, unpleasant taste, sweating, itching or burning sensation, headache, or trouble with speech or vision.

The usual recommended adult dose of Nubain is 10 mg for a 70 kg individual, administered subcutaneously, intramuscularly or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Nubain may interact with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or any other medicines that can make you sleepy or slow your breathing. Tell your doctor all medications you use. During pregnancy, Nubain should be used only if prescribed. This medication can pass into breast milk and may harm a nursing baby. Consult your doctor before breast-feeding. You may have withdrawal symptoms if you abruptly stop this medication.

Our Nubain (nalbuphine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nubain in Detail - Patient Information: Side Effects

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

Tell your caregivers at once if you have any of these serious side effects:

  • weak or shallow breathing;
  • fast or slow heart rate;
  • cold, clammy skin;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness or dizziness; or
  • feeling like you might pass out.

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

  • warmth, tingling, or redness under your skin;
  • nausea, vomiting,, stomach cramps;
  • dizziness, spinning sensation;
  • dry mouth, unpleasant taste;
  • sweating;
  • itching or burning sensation;
  • headache; or
  • trouble with speech or vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nubain (Nalbuphine hydrochloride) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nubain FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequent adverse reaction in 1066 patients treated in clinical studies with NUBAIN (nalbuphine hydrochloride) 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 (nalbuphine hydrochloride) : Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for NUBAIN (nalbuphine hydrochloride) : 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 (nalbuphine hydrochloride) treatment. Fetal death has been reported where mothers received NUBAIN (nalbuphine hydrochloride) during labor and delivery.

Drug Abuse And Dependence

There have been reports of abuse and dependence associated with NUBAIN (nalbuphine hydrochloride) among health care providers, patients and bodybuilders. There have been reported instances of psychological and physical dependence and tolerance in patients abusing NUBAIN (nalbuphine hydrochloride) . Individuals with a prior history of opioid or other substance abuse or dependence may be at greater risk in responding to reinforcing properties of NUBAIN (nalbuphine hydrochloride) .

Abrupt discontinuation of NUBAIN (nalbuphine hydrochloride) following prolonged use has been followed by symptoms of opioid withdrawal, i.e., abdominal cramps, nausea and vomiting, rhinorrhea, lacrimation, restlessness, anxiety, elevated temperature and piloerection.

Read the entire FDA prescribing information for Nubain (Nalbuphine hydrochloride) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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