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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.
Gastrointestinal: Cramps, dyspepsia, bitter taste.
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 Nubain (nalbuphine hydrochloride) Side Effects Center for a complete guide to possible side effects
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Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.
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