Adverse reactions : תופעות לוואי

4.8.    Undesirable effects
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.

Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (34%), insomnia (19%), agitation (15%), hyperkinesia (13%), headache (12%), psychotic disorder (9%), depression (8%), weight increased (8%), tremor (8%),
hypertonia (7%), orthostatic hypotension (7%), dystonia (6%) and somnolence (5%).

In addition, 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.

Table 2 lists adverse reactions as follows:

•    Reported in clinical studies with haloperidol.
•    Reported in clinical studies with haloperidol decanoate and relate to the active moiety.
•    From postmarketing experience with haloperidol and haloperidol decanoate.

Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol, 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.



Table 2: Adverse reactions
System Organ                                            Adverse Reaction Class
Frequency
Very           Common            Uncommon                 Rare             Not known Common
Blood and                                            Leukopenia                              Pancytopenia lymphatic system                                                                             Agranulocytosis disorders                                                                                    Thrombocytopen ia
Neutropenia
Immune system                                        Hypersensitivity                        Anaphylactic disorders                                                                                    reaction Endocrine                                                                Hyperprolactinaemia Inappropriate disorders                                                                                    antidiuretic hormone secretion
Metabolic and                                                                                Hypoglycaemia nutritional disorders
Psychiatric         Agitation      Psychotic         Confusional state disorders           Insomnia       disorder          Loss of libido
Depression        Libido decreased
Restlessness
Nervous system      Extrapyrami    Tardive           Convulsion           Neuroleptic         Akinesia disorders           dal disorder   dyskinesia        Parkinsonism         malignant           Cogwheel rigidity Hyperkinesi    Akathisia         Sedation             syndrome      Motor Masked facies a              Bradykinesia      Muscle               dysfunction
Headache       Dyskinesia        contractions         Nystagmus
Dystonia          involuntary
Hypokinesia
Hypertonia
Dizziness
Somnolence
Tremor
Eye disorders                      Oculogyric crisis Vision blurred
Visual disturbance
Cardiac disorders                                    Tachycardia                               Ventricular fibrillation
Torsade de pointes
Ventricular tachycardia
Extrasystoles
Vascular                           Hypotension disorders                          Orthostatic hypotension
Respiratory,                                         Dyspnoea             Bronchospasm         Laryngeal thoracic and                                                                                   oedema mediastinal                                                                                    Laryngospasm disorders
Gastrointestinal                   Vomiting disorders                          Nausea
Constipation
Dry mouth
Salivary hypersecretion


System Organ                                          Adverse Reaction Class
Frequency
Very        Common              Uncommon               Rare              Not known Common
Hepatobiliary                  Liver    function Hepatitis                                  Acute hepatic disorders                      test abnormal     Jaundice                                   failure Cholestasis
Skin and                       Rash                Photosensitivity                         Angioedema subcutaneous                                       reaction                                 Dermatitis tissue disorders                                   Urticaria                                exfoliative Pruritus                                 Leukocytoclastic
Hyperhidrosis                            vasculitis

Musculoskeletal                                    Torticollis Muscle Trismus               Rhabdomyolysis and connective                                     rigidity           Muscle twitching tissue disorders                                   Muscle spasms
Musculoskeletal stiffness
Renal and urinary              Urinary retention disorders
Pregnancy,                                                                                  Drug withdrawal puerperium and                                                                              syndrome perinatal                                                                                   neonatal     (see conditions                                                                                  section 4.6) Reproductive                   Erectile            Amenorrhoea         Menorrhagia          Priapism system and breast              dysfunction         Galactorrhoea       Menstrual disorder   Gynaecomastia disorders                                          Dysmenorrhoea       Sexual dysfunction Breast pain
Breast discomfort
General disorders                                  Hyperthermia                             Sudden death and                                                Oedema                                   Face oedema administration                                     Gait disturbance                         Hypothermia site conditions
Investigations                 Weight                                  Electrocardiogram increased                               QT 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.
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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form at the following link: https://sideeffects.health.gov.il