Risperdal -  Generic Name: risperidone

Risperdal is an antipsychotic drug that was approved to treat symptoms of schizophrenia.  It may, as with all medicines, cause some side effects.

Most common Risperdal side effects :  Anxiety; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; lightheadedness; nausea; restlessness; runny nose; stomach pain or upset; trouble sleeping; vomiting; weight gain

Severe Risperdal side effects:  Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; confusion; decreased sexual ability; drooling; enlarged breasts; fainting; fast or irregular heartbeat; fever; inability to control urination; increased sweating; missed menstrual period; new or worsening mental or mood changes (eg, aggression, agitation, severe anxiety); nipple discharge; prolonged painful erection; seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes.

Bipolar Mania In the US placebo-controlled trial with risperidone as monotherapy, approximately 8% (10/134) of Risperdal®-treated patients discontinued treatment due to an adverse event, compared with approximately 6% (7/125) of placebo-treated patients. The adverse events associated with discontinuation and considered to be possibly, probably, or very likely drug-related included paroniria, somnolence, dizziness, extrapyramidal disorder, and muscle contractions involuntary. Each of these events occurred in one Risperdal®-treated patient (0.7%) and in no placebo-treated patients (0%).

In the US placebo-controlled trial with risperidone as adjunctive therapy to mood stabilizers, there was no overall difference in the incidence of discontinuation due to adverse events (4% for Risperdal® vs. 4% for placebo).
 

Incidence in Controlled Trials

Commonly Observed Adverse Events in Controlled Clinical Trials

Schizophrenia

In two 6- to 8-week placebo-controlled trials, spontaneously-reported, treatment-emergent adverse events with an incidence of 5% or greater in at least one of the Risperdal® groups and at least twice that of placebo were anxiety, somnolence, extrapyramidal symptoms, dizziness, constipation, nausea, dyspepsia, rhinitis, rash, and tachycardia.

Adverse events were also elicited in one of these two trials (i.e., in the fixed-dose trial comparing Risperdal® at doses of 2, 6, 10, and 16 mg/day with placebo) utilizing a checklist for detecting adverse events, a method that is more sensitive than spontaneous reporting. By this method, the following additional common and drug-related adverse events occurred at an incidence of at least 5% and twice the rate of placebo: increased dream activity, increased duration of sleep, accommodation disturbances, reduced salivation, micturition disturbances, diarrhea, weight gain, menorrhagia, diminished sexual desire, erectile dysfunction, ejaculatory dysfunction, and orgastic dysfunction.

Bipolar Mania -  In the United States  placebo-controlled trial with risperidone as monotherapy, the most commonly observed adverse events associated with the use of Risperdal® (incidence of 5% or greater and at least twice that of placebo) were somnolence, dystonia, akathisia, dyspepsia, nausea, parkinsonism, vision abnormal, and saliva increased. In the US placebo-controlled trial with risperidone as adjunctive therapy to mood stabilizers, the most commonly observed adverse events associated with the use of Risperdal® were somnolence, dizziness, parkinsonism, saliva increased, akathisia, abdominal pain, and urinary incontinence.

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