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.
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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
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