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Avinza (Morphine Sulfate Extended Release) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In controlled and open label clinical studies, 560 patients with chronic malignant or non-malignant pain were treated with AVINZA. The most common serious adverse events reported with administration of AVINZA were vomiting, nausea, death, dehydration, dyspnea, and sepsis. (Deaths occurred in patients treated for pain due to underlying malignancy.) Serious adverse events caused by morphine include respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.

Adverse Events

The common adverse events seen on initiation of therapy with morphine are dose-dependent and are typical opioid‑related side effects. The most frequent of these include constipation, nausea and somnolence. The frequency of these events depends upon several factors including the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. These events should be anticipated and managed as part of opioid analgesia therapy.

The most common adverse events (seen in greater than 10%) reported by patients treated with AVINZA during the clinical trials at least once during therapy were constipation, nausea, somnolence, vomiting, and headache. Adverse events occurring in 5‑10% of study patients were peripheral edema, diarrhea, abdominal pain, infection, urinary tract infection, accidental injury, flu syndrome, back pain, rash, sweating, fever, insomnia, depression, paresthesia, anorexia, dry mouth, asthenia and dyspnea. Other less common side effects expected from opioid analgesics, including morphine, or seen in fewer than 5% of patients taking AVINZA in the clinical trials were:

Body as a Whole: malaise, withdrawal syndrome.

Cardiovascular System: bradycardia, hypertension, hypotension, palpitations, syncope, tachycardia.

Digestive System: biliary pain, dyspepsia, dysphagia, gastroenteritis, abnormal liver function tests, rectal disorder, thirst.

Hemic and Lymphatic System: anemia, thrombocytopenia.

Metabolic and Nutritional Disorders: edema, weight loss.

Musculoskeletal: skeletal muscle rigidity.

Nervous System: abnormal dreams, abnormal gait, agitation, amnesia, anxiety, ataxia, confusion, convulsions, coma, delirium, euphoria, hallucinations, lethargy, nervousness, abnormal thinking, tremor, vasodilation, vertigo .

Respiratory System: hiccup, hypoventilation, voice alteration.

Skin and Appendages: dry skin, urticaria.

Special Senses: amblyopia, eye pain, taste perversion.

Urogenital System: abnormal ejaculation, dysuria, impotence, decreased libido, oliguria, urinary retention.



REPORTS OF SUSPECTED AVINZA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Avinza side effects / adverse reactions in 42 year old male

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 42 year old male weighing 70.3 kg (154.6 pounds)

Reactions: Drug Dose Omission, Anxiety, Nausea, Diarrhoea, Hypertension

Suspect drug(s):
Avinza
    Dosage: 120 mg, 2x/day
    Administration route: Oral

Avinza
    Dosage: 60 mg, every 8 hrs
    Administration route: Oral
    Indication: Spinal Fracture

Other drugs received by patient: Oxycontin



Possible Avinza side effects / adverse reactions in 46 year old female

Reported by a physician from United States on 2012-01-13

Patient: 46 year old female

Reactions: Cardio-Respiratory Arrest

Adverse event resulted in: death

Suspect drug(s):
Avinza
    Dosage: unk
    Administration route: Oral

Clonazepam
    Dosage: unk

Acetaminophen W/ Propoxyphene HCL
    Dosage: unk

Pregabalin
    Dosage: unk



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

Reported by a physician from United States on 2012-01-13

Patient: 50 year old female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Thiazolidinedione
    Administration route: Oral

Pravastatin
    Administration route: Oral

Furosemide
    Administration route: Oral

Baclofen
    Administration route: Oral

Avinza
    Administration route: Oral

Pregabalin
    Administration route: Oral

Quinapril
    Administration route: Oral



See index of all Avinza side effect reports >>

Drug label data at the top of this Page last updated: 2006-08-08

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