ck (0.2%) and sedation (0.2%).
Most Common Adverse Reactions
The most commonly observed adverse reactions in TRD patients treated with SPRAVATO plusoral AD (incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) weredissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressureincreased, vomiting, and feeling drunk. Table 3 shows the incidence of adverse reactions thatoccurred in TRD patients treated with SPRAVATO plus oral AD at any dose and greater thanpatients treated with placebo nasal spray plus oral AD.
Table 3: Adverse Reactions Occurring in ≥2% of TRD Patients Treated with SPRAVATO + OralAD at Any Dose and at a Greater Rate than Patients Treated with Placebo Nasal Spray +
Oral AD
SPRAVATO + Oral AD
(N=346)
Placebo + Oral AD
(N=222)
Cardiac disorders
Tachycardia* 6 (2%) 1 (0.5%)
Ear and labyrinth disorders
Vertigo* 78 (23%) 6 (3%)
Gastrointestinal disorders
Constipation 11 (3%) 3 (1%)
Diarrhea 23 (7%) 13 (6%)
Dry mouth 19 (5%) 7 (3%)
Nausea 98 (28%) 19 (9%)
Vomiting 32 (9%) 4 (2%)
General disorders and administration site conditions
Feeling abnormal 12 (3%) 0 (0%)
Feeling drunk 19 (5%) 1 (0.5%)
Investigations
Blood pressure increased* 36 (10%) 6 (3%)
Nervous system disorders
Dizziness* 101 (29%) 17 (8%)
Dysarthria* 15 (4%) 0 (0%)
Dysgeusia* 66 (19%) 30 (14%)
Headache* 70 (20%) 38 (17%)
Hypoesthesia* 63 (18%) 5 (2%)
Lethargy* 37 (11%) 12 (5%)
Mental impairment 11 (3%) 2 (1%)
Sedation* 79 (23%) 21 (9%)
Psychiatric disorders
Anxiety* 45 (13%) 14 (6%)
Dissociation* 142 (41%) 21 (9%)
Euphoric mood 15 (4%) 2 (1%)
Insomnia 29 (8%) 16 (7%)
Renal and urinary disorders
Pollakiuria 11 (3%) 1 (0.5%)
Respiratory, thoracic and mediastinal disorders
Nasal discomfort* 23 (7%) 11 (5%)
Oropharyngeal pain 9 (3%) 5 (2%)
Throat irritation 23 (7%) 9 (4%)
Skin and subcutaneous tissue disorders
Hyperhidrosis 14 (4%) 5 (2%) * The following terms were combined:
Anxiety includes: agitation; anticipatory anxiety; anxiety; fear; feeling jittery; irritability; nervousness; panic attack; tensionBlood pressure increased includes: blood pressure diastolic increased; blood pressure increased; blood pressure systolic increased;
hypertensionDissociation includes: delusional perception; depersonalization/derealization disorder; derealization; diplopia; dissociation; dysesthesia;
feeling cold; feeling hot; feeling of body temperature change; hallucination; hallucination, auditory; hallucination, visual; hyperacusis;
illusion; ocular discomfort; oral dysesthesia; paranesthesia; paranesthesia oral; pharyngeal paranesthesia; photophobia; time perceptionaltered; tinnitus; vision blurred; visual impairment
Dizziness includes: dizziness; dizziness exertional; dizziness postural; procedural dizziness
Dysarthria includes: dysarthria; slow speech; speech disorder
Dysgeusia includes: dysgeusia; hypogeusia
Headache includes: headache; sinus headache
Hypoesthesia includes: hypoesthesia; hypoesthesia oral, hypoesthesia teeth, pharyngeal hypoesthesia
Lethargy includes: fatigue; lethargyNasal discomfort includes: nasal crusting; nasal discomfort; nasal dryness; nasal pruritus
Sedation includes: altered state of consciousness; hypersomnia; sedation; somnolence
Tachycardia includes: extrasystoles; heart rate increased; tachycardia
Vertigo includes: vertigo; |
