Tramadol (Similar TO Nda 21-745)



Indications and Reactions:

Role Indications Reactions
Primary
Product Used For Unknown Indication 70.8%
Pain 9.6%
Analgesic Therapy 2.7%
Back Pain 1.7%
Hypertension 1.7%
Osteoarthritis 1.7%
Depression 1.0%
Drug Use For Unknown Indication 1.0%
Hypermobility Syndrome 1.0%
Myalgia 1.0%
Neuralgia 1.0%
Osteoporosis 1.0%
Rheumatoid Arthritis 1.0%
Abdominal Pain 0.8%
Arthralgia 0.8%
Drug Abuse 0.7%
Headache 0.7%
Neck Pain 0.7%
Prophylaxis 0.7%
Pain In Extremity 0.5%
Drug Ineffective 12.5%
Inadequate Analgesia 10.0%
Vomiting 10.0%
Convulsion 7.5%
Overdose 6.3%
Constipation 5.0%
Hallucination 5.0%
Nausea 5.0%
Drug Abuse 3.8%
Drug Interaction 3.8%
Hallucination, Visual 3.8%
Hypoglycaemia 3.8%
Pain 3.8%
Respiratory Depression 3.8%
Suicide Attempt 3.8%
Adrenal Insufficiency 2.5%
Adverse Drug Reaction 2.5%
Breakthrough Pain 2.5%
Drug Effect Decreased 2.5%
Drug Withdrawal Syndrome 2.5%
Secondary
Product Used For Unknown Indication 27.1%
Pain 12.7%
Osteoarthritis 11.0%
Hypermobility Syndrome 8.6%
Myalgia 8.6%
Osteoporosis 8.6%
Rheumatoid Arthritis 8.6%
Hypertension 2.3%
Insomnia 2.3%
Alcoholic Liver Disease 1.2%
Constipation 1.2%
Fibromyalgia 1.2%
Gastritis Prophylaxis 1.2%
Headache 1.2%
Arthralgia 0.9%
Back Pain 0.9%
Depression 0.9%
Abdominal Pain 0.6%
Drug Abuse 0.6%
Muscle Spasms 0.6%
Drug Ineffective 16.2%
Suicidal Ideation 13.5%
Gastric Ulcer Haemorrhage 10.8%
Adrenal Insufficiency 5.4%
Confusional State 5.4%
Negative Thoughts 5.4%
Skin Toxicity 5.4%
Tremor 5.4%
Arteriosclerosis 2.7%
C-reactive Protein Increased 2.7%
Convulsion 2.7%
Delusion 2.7%
Drug Hypersensitivity 2.7%
Drug Prescribing Error 2.7%
Drug Withdrawal Syndrome 2.7%
Feeling Abnormal 2.7%
Flatulence 2.7%
Gait Disturbance 2.7%
Nausea 2.7%
Overdose 2.7%
Concomitant
Product Used For Unknown Indication 58.8%
Pain 21.2%
Breakthrough Pain 6.5%
Analgesic Therapy 5.9%
Back Pain 2.4%
Osteoarthritis 1.2%
Arthralgia 0.6%
Blood Cholesterol Increased 0.6%
Complex Regional Pain Syndrome 0.6%
Intervertebral Disc Degeneration 0.6%
Neck Pain 0.6%
Neuralgia 0.6%
Rib Fracture 0.6%
Inadequate Analgesia 22.4%
Nausea 14.3%
Drug Ineffective 12.2%
Drug Effect Decreased 8.2%
Product Adhesion Issue 6.1%
Application Site Rash 4.1%
Malaise 4.1%
Wrong Technique In Drug Usage Process 4.1%
Accidental Overdose 2.0%
Application Site Scab 2.0%
Arthralgia 2.0%
Breakthrough Pain 2.0%
Drug Effect Increased 2.0%
Drug Hypersensitivity 2.0%
Drug Withdrawal Syndrome 2.0%
Extra Dose Administered 2.0%
Hypoaesthesia 2.0%
Impaired Driving Ability 2.0%
Overdose 2.0%
Pain 2.0%