Adverse events observed with a frequency of ≥1% among patients who received ziprasidone in short-term placebo-controlled studies of its use in schizophrenia.
| Class of organ systems | Undesirable reactions and their frequency |
| Mental disorders | Often: agitation, insomnia. |
| Disturbances from the nervous system | Very often: drowsiness. Often: akathisia, dizziness, dystonia, extrapyramidal syndrome, headache, hypertension, tremor. |
| Vision disorders | Often: impaired vision. |
| Disorders from the digestive system | Often: constipation, dry mouth, dyspepsia, increased salivation, nausea, vomiting. |
| Systemic disorders and complications at the site of administration | Often: asthenia. |
Very often ≥10%; often ≥1%, but <10%
Cramps rarely occurred (less than 1% of patients who received ziprasidone). The Movement Disorder Burden Score, which reflects the severity of extrapyramidal symptoms, is significantly lower with ziprasidone (p <0.05) than with haloperidol or risperidone. Comparable changes were observed on the scale of akathisia assessment (Simpson Angus and Barnes akathisia scales) with ziprasidone and placebo. In addition, with the treatment of haloperidol and risperidone, the frequency of akathisia and the use of anticholinergic agents was higher than with ziprasidone.
It has been reported that the body weight fluctuation increases by an average of 0.5 kg for short-term admission (within 4-6 weeks) and downward by 1.3 kg in patients with an initially high body mass index at long-term admission (during the year ) in comparison with patients who did not take the drug.
On the background of maintenance therapy with ziprasidone, an increase in prolactin levels was sometimes observed, but in most cases it normalized without discontinuing treatment.
Adverse events with a frequency of ≥ 5% among patients who received ziprasidone in short-term placebo-controlled studies of its use in manic episodes of bipolar disorder.
| Disturbances from the nervous system | Very often: akathisia. dizziness, extrapyramidal syndrome, headache, drowsiness. Often: dystonia, hypertonus, tremor. |
| Disturbances on the part of the organ of sight | Often: impaired vision. |
| Disorders from the digestive system | Very often: nausea. Often: constipation. |
| Systemic disorders and complications at the site of administration | Often: asthenia. |
Very often ≥10%; often ≥ 1%, but <10%.
Side effects noted during postmarketing use of the drug.
Immune system disorders: an allergic reaction.
Mental disorders: insomnia, mania and hypomania.
Disturbances from the nervous system: paresis of the facial nerve, malignant neuroleptic syndrome; serotonin syndrome (when using ziprasidone inmonotherapy or in combination with serotonergic drugs) tardive dyskinesia.
Cardiac disorders: tachycardia, paroxysmal ventricular arrhythmia (torsade des pointes)
Disorders from the vascular system: postural hypotension, fainting.
Disorders from the digestive system: dysphagia, edema of the tongue.
Disturbances from the skin and subcutaneous tissue: angioedema, skin rashes.
Disorders from the urinary system: enuresis, urinary incontinence
Disorders from the reproductive system and breast: galactorrhea, priapism.
Malignant neuroleptic syndrome (CNS).
With the use of antipsychotic agents, cases of CNS, which is a rare but potentially fatal complication, have been observed. Clinical manifestations of CNS are fever (hyperpyrexia), muscle rigidity, changes in mental status and instability of the autonomic nervous system (arrhythmia, fluctuations in blood pressure, tachycardia, profuse sweating, heart rhythm disturbance). Additional signs may include increased levels of creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.If the patient develops symptoms that can be attributed to signs of the NSA, or if a high fever (hyperpyrexia) suddenly appears, not accompanied by the appearance of other symptoms of the NSA, all antipsychotics should be immediately discontinued, including ziprasidone.
CNS cases were noted in the post-marketing application of Zeldox®.
Late dyskinesia
With prolonged use of ziprasidone, as well as other antipsychotics, there is a risk of developing late dyskinesias and other distant extrapyramidal syndromes. When there are signs of dyskinesia, it is advisable to reduce the dose of ziprasidone or to cancel it.
Increase in the frequency of mortality with the use of neuroleptics in elderly patients with dementia, combined with psychosis.
A number of antipsychotics have been shown to increase, compared to placebo, the risk of death in elderly patients with psychosis, diagnosed with dementia. The results obtained during the research of ziprasidone do not allow to conclude that the risk of death in elderly patients with psychosis caused by dementia is increasing as the drug is taken. Nevertheless, ziprasidone It is not recommended for treatment of this category of patients.