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Table 3 Reported adverse events from randomization through week-12

From: A randomized controlled trial of intranasal oxytocin in Phelan-McDermid syndrome

Adverse events Placebo Oxytocin
Sedation 2 (20%) 1 (12.5%)
Decreased appetite 2 (20%) 0 (0%)
Periorbital/facial swelling 1 (10%) 0 (0%)
Diarrhea 1 (10%) 1 (12.5%)
Upper respiratory tract infection 2 (20%) 1 (12.5%)
Sleep disturbance 2 (20%) 5 (62.5%)
Increased appetite 1 (10%) 1 (12.5%)
Irritability/agitation 3 (30%) 1 (12.5%)
Cough 0 (0%) 1 (12.5%)
Runny nose/congestion 1 (10%) 0 (0%)
Fever 5 (50%) 2 (25%)
Aggression/self-injury 1 (10%) 0 (0%)
Infection 3 (30%) 2 (25%)
Elated mood/silliness 1 (10%) 3 (37.5%)
Leg weakness 1 (10%) 1 (12.5%)
Restlessness/hyperactivity 1 (10%) 5 (62.5%)
Bloody nose 0 (0%) 2 (25%)
Stereotypies 2 (20%) 1 (12.5%)
Apathy 0 (0%) 1 (12.5%)
Foot pain 1 (10%) 0 (0%)
Hirsutism 0 (0%) 1 (12.5%)
Tooth pain 0 (0%) 1 (12.5%)
Eczema 1 (10%) 1 (12.5%)
Allergies/asthma 2 (20%) 2 (25%)
Enuresis 1 (10%) 0 (0%)
Accidental injury 1 (10%) 0 (0%)
Seizure 1 (10%) 0 (0%)
Rubbing ears 1 (10%) 0 (0%)
Disinhibited 1 (10%) 0 (0%)
Oppositional behavior 2 (20%) 0 (0%)
Low frustration tolerance 1 (10%) 1 (12.5%)
Tantrums 0 (0%) 1 (12.5%)
Total 41 35