Table 3.

Reported adverse events from randomization through week-12

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