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Naloxone (Naloxone Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Postoperative

The following adverse events have been associated with the use of naloxone hydrochloride injection in postoperative patients: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone in postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE and ADMINISTRATION; Usage in Adults-Postoperative Opioid Depression).

Opioid Depression

Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death (see PRECAUTIONS).

Opioid Dependence

Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute withdrawal syndrome which may include, but not limited to the following signs and symptoms: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes (See WARNINGS).

Adverse events associated with the postoperative use of naloxone hydrochloride injection are listed by organ system and in decreasing order of frequency as follows:

Cardiac Disorders: pulmonary edema, cardiac arrest or failure, tachycardia, ventricular fibrillation, and ventricular tachycardia. Death, coma, and encephalopathy have been reported as sequelae of these events.

Gastrointestinal Disorders: vomiting, nausea

Nervous System Disorders: convulsions, paraesthesia, grand mal convulsion

Psychiatric Disorders: agitation, hallucination, tremulousness

Respiratory, Thoracic, and Mediastinal Disorders: dyspnea, respiratory depression, hypoxia

Skin and Subcutaneous Tissue Disorders: nonspecific injection site reactions, sweating

Vascular Disorders: hypertension, hypotension, hot flashes, or flushing

See also PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults, Postoperative Opioid Depression



REPORTS OF SUSPECTED NALOXONE SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Naloxone side effects / adverse reactions in 50 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-24

Patient: 50 year old female

Reactions: Vomiting, Head Injury, Diarrhoea, Chest Pain, Fall

Adverse event resulted in: hospitalization

Suspect drug(s):
Oxycontin
    Dosage: 160 mg, daily
    Administration route: Oral
    Indication: Pain
    End date: 2011-08-30

Coloxyl with Senna
    Dosage: 300 mg, daily
    Indication: Constipation
    Start date: 2011-08-26
    End date: 2011-08-29

Naloxone
    Dosage: 80 mg, single
    Administration route: Oral
    Indication: Pain
    Start date: 2011-08-30
    End date: 2011-08-30

Water
    Dosage: 4 l, see text
    Indication: Constipation
    Start date: 2011-08-30
    End date: 2011-08-30

Movicol /01749801/
    Dosage: 2 packet, daily
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-08-26
    End date: 2011-08-29

Naloxone
    Indication: Constipation

Other drugs received by patient: Chlorvescent



Possible Naloxone side effects / adverse reactions in 30 year old female

Reported by a physician from Korea, Republic of on 2011-12-07

Patient: 30 year old female

Reactions: Lymphocyte Count Decreased

Suspect drug(s):
Ornithine Aspartate
    Indication: Prophylaxis
    Start date: 2011-03-20

Levetiracetam
    Indication: Convulsion
    Start date: 2011-03-20
    End date: 2011-03-22

Naloxone
    Indication: Dyspnoea
    Start date: 2011-03-20

Methylprednisolone
    Indication: Bronchial Oedema
    Start date: 2011-03-20

Other drugs received by patient: Diomagnate; IV-Globulin; Furosemide; Norepinephrine Bitartrate; Ceftriaxone; Poapacetamol; Kelora; Clindamycin; Nadolol; Cerebyx; Ranitidine; Mesna; Acetaminophen; Dopamine HCL; Urdeoxycholic Acid; Galic OIL ETC



Possible Naloxone side effects / adverse reactions in 44 year old male

Reported by a physician from Germany on 2011-12-08

Patient: 44 year old male

Reactions: Gamma-Glutamyltransferase Increased, Sensory Disturbance, Visual Acuity Reduced, Hypoaesthesia, Paraesthesia

Adverse event resulted in: hospitalization

Suspect drug(s):
Naloxone
    Dosage: 20/10 mg per day
    Administration route: Oral
    Indication: Complex Regional Pain Syndrome
    Start date: 2011-09-17

Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Complex Regional Pain Syndrome
    Start date: 2011-09-17
    End date: 2011-01-01

Lyrica
    Dosage: 450 mg per day
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-10-01

Other drugs received by patient: Flupirtine Maleate; Amitriptyline HCL



See index of all Naloxone side effect reports >>

Drug label data at the top of this Page last updated: 2008-10-02

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