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Nubain (Nalbuphine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most frequent adverse reaction in 1066 patients treated in clinical studies with NUBAIN 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

Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for NUBAIN: 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 treatment. Fetal death has been reported where mothers received NUBAIN during labor and delivery.



REPORTS OF SUSPECTED NUBAIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nubain. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nubain side effects / adverse reactions in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-20

Patient: 54 year old male

Reactions: Hypersensitivity, Drug Hypersensitivity, Peripheral Arterial Occlusive Disease, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Humira
    Dosage: 40 mg/0.8 ml
    Indication: Psoriatic Arthropathy
    Start date: 2009-01-06

Nubain
    Dosage: unk
    Indication: Pain
    Start date: 2010-05-01
    End date: 2010-05-01

Other drugs received by patient: Ramipril; Kapsovit; Milk Thistle; Aspirin; Aludrox; Colecalciferol; Ubidecarenone



Possible Nubain side effects / adverse reactions in 10 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-16

Patient: 10 year old female weighing 49.6 kg (109.1 pounds)

Reactions: Mucosal Inflammation, Hyperpyrexia, Leukoencephalopathy, Leukopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Morphine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-03
    End date: 2011-10-05

Etoposide
    Indication: Bone Sarcoma
    End date: 2011-09-01

Ifosfamide
    Indication: Bone Sarcoma
    End date: 2011-09-01

Nubain
    Indication: Pain
    Start date: 2011-09-28
    End date: 2011-10-03

Amoxicillin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-02
    End date: 2011-10-08

Methotrexate
    Indication: Bone Sarcoma
    End date: 2011-09-26

Amikacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-02
    End date: 2011-10-08

Other drugs received by patient: Leucovorin Calcium; Etoposide; Zometa; Zofran; Uromitexan; Plitican; Zofran



Possible Nubain side effects / adverse reactions in 10 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-23

Patient: 10 year old female weighing 49.6 kg (109.1 pounds)

Reactions: Mucosal Inflammation, Hyperpyrexia, Leukoencephalopathy, Leukopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Morphine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-03
    End date: 2011-10-05

Amoxicillin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-02
    End date: 2011-10-08

Methotrexate
    Indication: Bone Sarcoma
    End date: 2011-09-26

Ifosfamide
    Indication: Bone Sarcoma
    End date: 2011-09-01

Etoposide
    Indication: Bone Sarcoma
    End date: 2011-09-01

Nubain
    Indication: Pain
    Start date: 2011-09-28
    End date: 2011-10-03

Amikacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-02
    End date: 2011-10-08

Other drugs received by patient: Etoposide; Plitican; Zofran; Zofran; Zometa; Leucovorin Calcium; Uromitexan



See index of all Nubain side effect reports >>

Drug label data at the top of this Page last updated: 2006-06-28

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