Rimonabant Acomplia

Side Effects

In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7 % for patients receiving rimonabant. The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.

Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg. These were usually mild or moderate in severity and resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups.

The following table shows all treatment-emergent adverse reactions from four placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events greater than or equal to 1 %) or considered clinically relevant (for events fewer than 1 %).

Classification of expected frequencies of undesirable effects:

Very common (More than 10 out of 100); Common (More than 1 in 100 but fewer than 10 in 100); Uncommon (More than 1 in 1,000 but fewer than 1 in 100); Rare (More than 1 in 10,000 but fewer than 1 in 1,000); Very rare (Fewer than 1 in 10,000), Not known (cannot be established from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class	Very common	Common	Uncommon	Rare
Infections and infestations	Upper respiratory tract infection	Gastroenteritis
Psychiatric disorders		Depressive disorders Mood alterations with depressive symptoms Anxiety Irritability Nervousness Sleep disorders Insomnia Parasomnias	Panic symptoms Anger Dysphoria Emotional disorder	Hallucinations
Nervous system disorders		Memory loss Dizziness Hypoaesthesia Sciatica	Lethargy
Vascular disorders		Hot flush
Respiratory, thoracic and mediastinal disorders			Hiccups
Gastrointestinal disorders	Nausea	Diarrhoea Vomiting
Skin and subcutaneous tissue disorders		Pruritus Hyperhidrosis	Night sweats
Musculoskeletal and connective tissue disorders		Tendonitis Muscle cramp Muscle spasms
General disorders		Asthenia/fatigue Influenza
Injury, Poisoning and procedural complications		Fall, Contusion, Joint sprain