General Adverse Events in Clinical Trials

FATIGUE: Persistent tiredness not relieved by rest.

FEVER: Elevated body temperature due to infection or inflammation.

HEADACHE: Pain or discomfort in the head or upper neck.

DIZZINESS: A feeling of lightheadedness or unsteadiness.

NAUSEA: Sensation of wanting to vomit.

VOMITING: Forceful expulsion of stomach contents.

DIARRHEA: Frequent, watery bowel movements.

CONSTIPATION: Difficulty or infrequency in passing stools.

ABDOMINAL PAIN: Pain localized in the stomach area.

ALLERGIC REACTIONS: Immune response causing rash, itching, or swelling.

HYPERTENSION: Abnormally high blood pressure.

HYPOTENSION: Abnormally low blood pressure.

TACHYCARDIA: Faster than normal heart rate.

BRADYCARDIA: Slower than normal heart rate.

CHEST PAIN: Discomfort or pain in the chest area.

PALPITATIONS: Irregular or rapid heartbeat sensations.

MYOCARDIAL INFARCTION: Blockage causing heart attack.

DEEP VEINTHROMBOSIS: Blood clot in a deep vein, often in legs.

STROKE: Disruption of blood flow to the brain.

PERIPHERAL EDEMA: Swelling in arms or legs due to fluid retention.

SHORTNESSOF BREATH: Difficulty breathing or feeling breathless.

COUGH: Forceful release of air to clear the throat or lungs.

PULMONARY EMBOLISM: Blockage in a lung artery.

PNEUMONIA: Infection causing inflammation in the lungs.

WHEEZING: High-pitched sound during breathing.

NASAL CONGESTION: Blocked nasal passages due to swelling or mucus.

RESPIRATORY FAILURE: Inability of the lungs to provide adequate oxygen.

SEIZURES: Sudden, uncontrolled electrical activity in the brain.

TREMORS: Involuntary rhythmic muscle movements.

PARESTHESIA: Tingling or numbness often felt in extremities.

MEMORY LOSS: Impaired ability to recall information or events.

CONFUSION: Difficulty thinking clearly or making decisions.

ANXIETY: Excessive worry or fear affecting daily activities.

DEPRESSION: Persistent low mood or loss of interest in activities.

GERD: Acid reflux causing heartburn.

GASTROINTESTINAL BLEEDING: Blood loss within the digestive tract.

JAUNDICE: Yellowing of the skin and eyes due to liver dysfunction.

PANCREATITIS: Inflammation of the pancreas causing abdominal pain.

HEPATOTOXICITY: Liver damage caused by chemicals or medications.

ERYTHEMA: Redness of the skin due to inflammation or irritation.

URTICARIA: Raised, itchy welts on the skin, also called hives.

PHOTOSENSITIVITY: Increased skin sensitivity to sunlight.

HAIR LOSS: Loss of hair from the scalp or body, known as alopecia.

MUSCLE PAIN: Soreness or aches in the muscles, also called myalgia.

JOINT PAIN: Pain in the joints, often due to inflammation or injury.

BONE FRACTURES: Breaks in bones caused by trauma or weakness.

MUSCLEWEAKNESS: Reduced strength in muscles, limiting movement.

ANEMIA: Low red blood cell count causing fatigue and weakness.

THROMBOCYTOPENIA: Decreased platelet count leading to easy bruising or bleeding.


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Resource Person: Brindha Chandrasekaran

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