UNIT 4: Severity Grading and Types of ADRs
This unit explains how adverse events are graded based on clinical severity and how special safety scenarios are handled in Pharmacovigilance. It clarifies practical severity grading with real clinical interpretation and covers high-risk situations such as pregnancy, pediatrics, geriatrics, hypersensitivity, and drug–drug interactions.
Based on intensity and severity of the adverse events, it is classified into 5 different types
| Grade | Severity Level | Clinical Description | Risk Management Plan |
|---|---|---|---|
| Grade 0 | Nill | No pain, No symptoms but feels unwell | Rest |
| Grade 1 | Mild | Tolerable, transient symptoms requiring no treatment or intervention | Rest |
| Grade 2 | Moderate | Symptoms requiring minimal medical intervention and non tolerable | Consult Physician and non invasive therapies such as oral medication |
| Grade 3 | Severe | Required Hospitalization | Invasive therapies like IV, IM treatments |
| Grade 4 | Life-threatening | Immediate risk to life requiring urgent intervention | ICU or proper ventilation required |
| Grade 5 | Death | Event results in patient death | N/A |
Explore Our Courses
Master life sciences with comprehensive courses in regulatory science, clinical research, and pharmacovigilance.
How was this unit?
Your feedback helps us improve our content
Don't just guess—prove it! Take a quick MCQ test to challenge your understanding and boost your retention.
#severity grading#special populations#pregnancy cases#hypersensitivity#drug interactions