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Table 10. Adverse Reactions (≥2%) Reported in CLOZARIL-treated Patients (N=842) Across all CLOZARIL Studies (excluding the 2-year InterSePTTM Study)

Body System Adverse Reaction*

CLOZARIL

N=842

Percentage of Patients

Body System Adverse Reaction*

Central Nervous System:

  1. Drowsiness/Sedation 39
  2. Dizziness/Vertigo 19
  3. Headache 7
  4. Tremor 6
  5. Syncope 6
  6. Disturbed Sleep/Nightmares 4
  7. Restlessness 4
  8. Hypokinesia/Akinesia 4
  9. Agitation 4
  10. Seizures (convulsions) 3†
  11. Rigidity 3
  12. Akathisia 3
  13. Confusion 3
  14. Fatigue 2
  15. Insomnia 2

Cardiovascular:

  1. Tachycardia 25†
  2. Hypotension 9
  3. Hypertension 4

Gastrointestinal:

  1. Constipation 14
  2. Nausea 5
  3. Abdominal Discomfort/Heartburn 4
  4. Nausea/Vomiting3
  5. Vomiting 3
  6. Diarrhea 2

Urogenital:

  1. Urinary Abnormalities 2

Autonomic Nervous System:

  1. Salivation 31
  2. Sweating 6
  3. Dry Mouth 6
  4. Visual Disturbances 5

Skin:

  1. Rash 2

Hemic/Lymphatic:

  1. Leukopenia/Decreased WBC/Neutropenia 3

Miscellaneous:

  1. Fever 4
  2. Weight Gain 5

†Rate based on population of approximately 1700 exposed during premarket clinical evaluation of CLOZARIL.


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