Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The safety of haloperidol decanoate was evaluated in 410 patients who participated in 3 comparator studies (1 comparing haloperidol decanoate versus fluphenazine and 2 comparing the decanoate formulation to oral haloperidol), 9 open label studies and 1 dose response study.

Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (14%), tremor (8%), parkinsonism (7%), muscle rigidity (6%) and somnolence (5%).

In addition, the safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 double-blind active comparator-controlled clinical studies.

Table 3 lists adverse reactions as follows:

•      Reported in clinical studies with haloperidol decanoate.
•      Reported in clinical studies with haloperidol (non-decanoate formulations) and relate to the active moiety.
•      From postmarketing experience with haloperidol decanoate and haloperidol.

Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol decanoate, and classified using the following convention: 
Very common:       ≥1/10
Common:            ≥1/100 to <1/10
Uncommon:          ≥1/1,000 to <1/100
Rare:              ≥1/10,000 to <1/1,000
Very rare:         <1/10,000
Not known:         cannot be estimated from the available data.

The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.



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Table 3: Adverse reactions

System Organ                                         Adverse Reaction Class
Frequency
Very          Common              Uncommon        Rare          Not known Common
Blood and                                                                      Pancytopenia lymphatic                                                                      Agranulocytosis system                                                                         Thrombocytopenia disorders                                                                      Leukopenia Neutropenia
Immune                                                                         Anaphylactic reaction system                                                                         Hypersensitivity disorders
Endocrine                                                                      Inappropriate antidiuretic disorders                                                                      hormone secretion Hyperprolactinaemia
Metabolic and                                                                  Hypoglycaemia nutritional disorders
Psychiatric                       Depression                                   Psychotic disorder disorders                         Insomnia                                     Agitation Confusional state
Loss of libido
Libido decreased
Restlessness
Nervous            Extrapyramidal Akathisia        Akinesia                    Neuroleptic malignant system             disorder       Parkinsonism     Dyskinesia                  syndrome disorders                         Masked facies    Dystonia                    Tardive dyskinesia Tremor           Cogwheel rigidity           Convulsion
Somnolence       Hypertonia                  Bradykinesia
Sedation         Headache                    Hyperkinesia
Hypokinesia
Dizziness
Muscle contractions involuntary
Motor dysfunction
Nystagmus
Eye disorders                                      Oculogyric crisis
Vision blurred
Visual disturbance
Cardiac                                            Tachycardia                 Ventricular fibrillation disorders                                                                      Torsade de pointes Ventricular tachycardia
Extrasystoles
Vascular                                                                       Hypotension disorders                                                                      Orthostatic hypotension Respiratory,                                                                   Laryngeal oedema thoracic and                                                                   Bronchospasm mediastinal                                                                    Laryngospasm disorders                                                                      Dyspnoea Gastrointestinal                  Constipation                                 Vomiting disorders                         Dry mouth                                    Nausea Salivary hypersecretion



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System Organ                                        Adverse Reaction Class
Frequency
Very           Common              Uncommon       Rare           Not known Common
Hepatobiliary                                                                   Acute hepatic failure disorders                                                                       Hepatitis Cholestasis
Jaundice
Liver function test abnormal
Skin and                                                                        Angioedema subcutaneous                                                                    Dermatitis exfoliative tissue                                                                          Leukocytoclastic disorders                                                                       vasculitis Photosensitivity reaction
Urticaria
Pruritus
Rash
Hyperhidrosis
Musculoskeletal                   Muscle                                        Rhabdomyolysis and connective                    rigidity                                      Torticollis tissue disorders                                                                Trismus Muscle spasms
Muscle twitching
Musculoskeletal stiffness
Renal and                                                                       Urinary retention urinary disorders
Pregnancy,                                                                      Drug withdrawal puerperium                                                                      syndrome neonatal (see and perinatal                                                                   section 4.6) conditions
Reproductive                      Sexual                                        Priapism system and                        dysfunction                                   Amenorrhoea breast                                                                          Galactorrhoea disorders                                                                       Dysmenorrhoea Menorrhagia
Erectile dysfunction
Gynaecomastia
Menstrual disorder
Breast pain
Breast discomfort
General                           Injection site                                Sudden death disorders and                     reaction                                      Face oedema administration                                                                  Oedema site conditions                                                                 Hyperthermia Hypothermia
Gait disturbance
Injection site abscess
Investigations                    Weight                                        Electrocardiogram QT increased                                     prolonged
Weight decreased

Electrocardiogram QT prolonged, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), torsade de pointes and sudden death have been reported with haloperidol.

Class effects of antipsychotics

Cardiac arrest has been reported with antipsychotics.
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Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotics. The frequency is unknown.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health, according to the National Regulation by using an online form: https://sideeffects.health.gov.il