Sativex achieved sustained
improvements in spasticity vs
placebo when used as an adjunct1

Safety and tolerability
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Sativex was
generally
well tolerated,
with comparable
AE rates
to placebo1–5

The most common AEs are usually mild6

Dizziness and fatigue are the only very common AEs associated with Sativex

 

They normally occur during the first 4 weeks of treatment and resolve in a few days if treatment is continued6

Less than 5% of patients had serious AEs1–5,7,8

0–4.8% and 0–2.6% of patients had serious AEs in clinical trials and long-term registries, respectively1–5,7,8

Low discontinuation rates1–4

2.1–6.4% discontinuation rate due to AEs in clinical trials1–4

 

16.3% of patients discontinued Sativex due to AEs in a registry with a median follow up of 2 years9

AEs associated with Sativex6

MedDRA system organ class

Very common (≥1/10)

Common (≥1/100 to <1/10)
 

Uncommon (≥1/1,000 to <1/100)
 

Infections and infestations Pharyngitis
Metabolism and nutrition disorders Anorexia (including appetite decreased), appetite increased
Psychiatric disorders Depression, disorientation, dissociation, euphoric mood Hallucination (unspecified, auditory, visual), illusion, paranoia, suicidal ideation, delusional perception*
Nervous system disorders Dizziness Amnesia, balance disorder, disturbance in attention, dysarthria, dysgeusia, lethargy, memory impairment, somnolence Syncope
Eye disorders Vision blurred
Ear and labyrinth disorders Vertigo
Cardiac disorders Palpitations, tachycardia
Vascular disorders Hypertension
Respiratory, thoracic and mediastinal disorders Throat irritation
Gastrointestinal disorders Constipation, diarrhoea, dry mouth, glossodynia, mouth ulceration, nausea, oral discomfort, oral pain, vomiting Abdominal pain (upper), oral mucosal discolouration,* oral mucosal disorder, oral mucosal exfoliation,* stomatitis, tooth discolouration
General disorders and administration site conditions Fatigue Application site pain, asthenia, feeling abnormal, feeling drunk, malaise Application site irritation
Injury, poisoning and procedural complaints Fall