Oxycontin (Nda 22-272)



Indications and Reactions:

Role Indications Reactions
Primary
Product Used For Unknown Indication 51.2%
Pain 23.9%
Drug Abuse 6.0%
Back Pain 5.0%
Breakthrough Pain 4.2%
Substance Abuse 1.2%
Analgesic Therapy 0.9%
Arthralgia 0.9%
Neck Pain 0.7%
Cancer Pain 0.7%
Neuralgia 0.7%
Fibromyalgia 0.6%
Intervertebral Disc Degeneration 0.6%
Drug Dependence 0.6%
Arthritis 0.5%
Intervertebral Disc Protrusion 0.5%
Neuropathy Peripheral 0.4%
Pain In Extremity 0.4%
Rheumatoid Arthritis 0.4%
Anxiety 0.4%
Drug Ineffective 9.2%
Drug Effect Decreased 8.7%
Vomiting 8.4%
Drug Dependence 8.2%
Pain 8.0%
Inadequate Analgesia 7.7%
Nausea 7.7%
Drug Abuse 5.8%
Medication Residue Present 5.1%
Substance Abuse 4.0%
Wrong Technique In Drug Usage Process 3.9%
Somnolence 3.6%
Overdose 3.4%
Unevaluable Event 3.1%
Therapeutic Response Delayed 3.0%
Drug Withdrawal Syndrome 2.4%
Malaise 2.0%
Feeling Abnormal 2.0%
Pruritus 2.0%
Intentional Drug Misuse 1.9%
Secondary
Product Used For Unknown Indication 36.9%
Pain 20.6%
Back Pain 9.0%
Breakthrough Pain 5.6%
Arthralgia 3.6%
Neck Pain 3.2%
Arthritis 2.6%
Intervertebral Disc Protrusion 2.4%
Intervertebral Disc Degeneration 2.4%
Fibromyalgia 1.9%
Drug Abuse 1.7%
Pain In Extremity 1.5%
Neuropathy Peripheral 1.3%
Osteoarthritis 1.2%
Anxiety 1.2%
Cancer Pain 1.2%
Musculoskeletal Pain 1.0%
Neuralgia 1.0%
Rheumatoid Arthritis 0.9%
Depression 0.8%
Vomiting 15.7%
Pain 13.9%
Inadequate Analgesia 7.3%
Drug Effect Decreased 7.1%
Unevaluable Event 6.2%
Drug Ineffective 5.9%
Nausea 5.9%
Therapeutic Response Delayed 5.9%
Medication Residue Present 5.7%
Somnolence 5.1%
Weight Decreased 3.5%
Wrong Technique In Drug Usage Process 2.9%
Drug Dependence 2.4%
Pruritus 2.2%
Suicidal Ideation 2.2%
Drug Abuse 1.8%
Pneumonia 1.6%
Road Traffic Accident 1.6%
Tremor 1.6%
Headache 1.5%
Concomitant
Product Used For Unknown Indication 43.5%
Pain 19.6%
Breakthrough Pain 15.2%
Spinal Column Stenosis 8.7%
Scoliosis 4.3%
Back Pain 2.2%
Cancer Pain 2.2%
Intervertebral Disc Degeneration 2.2%
Spinal Osteoarthritis 2.2%
Drug Ineffective 42.1%
Tremor 21.1%
Application Site Rash 5.3%
Drug Effect Decreased 5.3%
Drug Withdrawal Syndrome 5.3%
Feeling Abnormal 5.3%
Local Swelling 5.3%
Respiratory Depression 5.3%
Strabismus 5.3%
Interacting
Product Used For Unknown Indication 50.0%
Complex Regional Pain Syndrome 15.4%
Deep Vein Thrombosis 7.7%
Muscle Disorder 7.7%
Nervous System Disorder 7.7%
Heart Transplant 3.8%
Procedural Pain 3.8%
Pulmonary Hypertension 3.8%
Hyperhidrosis 50.0%
Myoclonus 25.0%
Unevaluable Event 25.0%