Table 3 Adverse events
Omega-3 | Placebo |
|---|---|
Neuropsychiatric disorders | Neuropsychiatric disorders |
• Overactivity (3) | • Decreased energy (2) |
• Decreased energy (4) | • Social communicative intent loss (1) |
• Social communicative intent loss (1) | • Increased emotional lability (3) |
• Starring spell (1) | • Increase irritability/anger/aggression (4) |
• Headache (1) |  |
• Stuttering (1) |  |
• Increase emotional lability (1) |  |
• Increase irritability/anger/aggression (10) |  |
Sleep disturbances | Sleep disturbances |
• Initial insomnia (6) | • Initial insomnia (4) |
• Mid-cycle insomnia (6) | • Mid-cycle insomnia (3) |
• Early awakening (1) | • Nightmares (1) |
• Non-restorative sleep (1) |  |
• Nightmares (1) |  |
Nutritional and gastrointestinal disorders | Nutritional and gastrointestinal disorders |
• Increased appetite (1) | • Decreased appetite (3) |
• Decreased appetite (7) | • Abdominal pain (4) |
• Decreased dietary variety (1) | • Vomiting (3) |
• Abdominal pain (6) | • Diarrhea (9) |
• Regurgitation (1) | • Constipation (7) |
• Vomiting (4) |  |
• Diarrhea (5) |  |
• Constipation (7) |  |
Eyes, ears, nose, teeth, and throat | Eyes, ears, nose, teeth, and throat |
• Eye swelling (1) | • Red eyes (1) |
• Nearsightedness (1) | • Nose bleed (3) |
• Eye surgery (1) | • Tonsillectomy (1) |
• Earache (3) |  |
Allergic | Allergic |
• Nasal congestion (2) | • Nasal congestion (1) |
• Cough (3) | • Cough (4) |
Urogenital disorders | Urogenital disorders |
• Day time wetting (1) | • Pain on urination (1) |
|  | • Change in urine colour (1) |
Musculoskeletal disorders | Musculoskeletal disorders |
• Muscle ache (1) | • Left knee injury (1) |
• Right leg internal rotation (2) |  |
Skin and subcutaneous disorders | Skin and subcutaneous disorders |
• Rash (10) | • Rash (9) |
• Eczema (2) | • Eczema (4) |
• Bruising (4)) | • Bruising (2) |
• Dry skin (1) | • Dry skin (2) |
|  | • Flaky scalp (1) |
Infections | Infections |
• Upper respiratory infections (23) | • Upper respiratory infections (24) |
• Fever (4) | • Fever (5) |
• Ear infection (1) | • Bronchiolitis (3) |
• Gastroenteritis (1) | • Ear infection (3) |
• Skin infection (1) | • Gastroenteritis (2) |
|  | • Skin infection (1) |
|  | • Hand mouth foot disease (2) |
|  | • Roseola (1) |
Serious adverse event: 0 | Serious adverse event: 0 |