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ACOMPLIA (RIMONABANT): ADVERSE REACTIONS, SIDE EFFECTS

Rimonabant (Acomplia) 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications. 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 factors treated with Acomplia (Rimonabant) tablets 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.

Below there are all treatment-emergent adverse reactions from 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 >= 1%) or considered clinically relevant (for events < 1%).

Classification of expected frequencies of undesirable effects: Very common (>=10%); Common (>=1, < 10%); Uncommon (>=0.1, < 1%); Rare (>=0.01, < 0.1%); Very rare (< 0.01%), Not known (cannot be estimated from the available data).

Infections and infestations:
Very common: upper respiratory tract infection
Common: gastroenteritis

Metabolism and nutrition disorders:
Uncommon: hypoglycaemia

Psychiatric disorders:
Common: depressive disorders, mood alterations with depressive symptoms, anxiety, irritability, nervousness, sleep disorders, insomnia, parasomnias
Uncommon: panic symptoms, dysphoria, anger, emotional disorder, aggressiveness, suicidal ideation, aggressive behaviour
Rare: hallucinations

Nervous system disorders:
Common: memory loss, hypoaesthesia, dizziness, sciatica, paresthesia
Uncommon: lethargy, tremor

Vascular disorders:
Common: hot flush

Respiratory, thoracic and mediastinal disorders:
Uncommon: hiccups

Gastrointestinal disorders:
Very common: nausea
Common: diarrhoea, vomiting

Skin and subcutaneous tissue disorders:
Common: pruritus, hyperhidrosis
Uncommon: night sweats

Musculoskeletal and connective tissue disorders:
Common: tendonitis, muscle cramp, muscle spasms

General disorders:
Common: asthenia/fatigue, influenza

Injury, poisoning and procedural complications:
Common: fall contusion, joint sprain

In clinical studies for other indications, the following additional adverse reactions were commonly reported:

  • infections and infestations: sinusitis
  • metabolism and nutrition disorders: anorexia, decreased appetite
  • gastrointestinal disorders: stomach discomfort, dry mouth.

    Post-Marketing

    In addition the following adverse reactions were reported during postmarketing (frequency not known):
  • Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia.
  • Skin and subcutaneous tissue disorders: rash.
  • Nervous disorders: convulsions, disturbance in attention, headache.
  • Gastrointestinal disorders: abdominal pain.

    Laboratory adverse events

    Rimonabant (Acomplia) tablets has not been shown to alter laboratory test values.

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