ADVERSE REACTIONS
The following serious adverse reactions and/or conditions are discussed elsewhere in the labeling:
- Respiratory Depression [see Warnings and Precautions]
- Chronic Pulmonary Disease [see Warnings and Precautions]
- Head Injuries and Increased Intracranial Pressure [see Warnings and Precautions]
- Interactions with Other CNS Depressants [see Warnings and Precautions]
- Hypotensive Effect [see Warnings and Precautions
- Gastrointestinal Effects [see Warnings and Precautions
- Seizures [see Warnings and Precautions
The most common adverse reactions with AVINZA include constipation, nausea and somnolence.
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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.
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.
Anaphylaxis has been reported with ingredients contained in AVINZA. Advise patients how to recognize such a reaction and when to seek medical attention.
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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
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