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 |