Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile
Approximately 600 patients were treated with paricalcitol in Phase II/III/IV clinical trials.
Overall, 6% of the paricalcitol treated patients reported adverse reactions.


The most common adverse reaction associated with paricalcitol therapy was hypercalcaemia, occurring in 4.7% of patients. Hypercalcaemia is dependent on the level of PTH oversuppression and can be minimised by proper dose titration.

Tabulated List of adverse reactions:
Adverse events at least possibly related to paricalcitol, both clinical and laboratory are displayed by MedDRA System Organ Class, Adverse reaction and frequency. The following frequency groupings are used: Very common ( ≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10,000, <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).


System Organ Class                  Preferred Term                   Frequency Infections and                Sepsis, pneumonia, infection     Uncommon infestations                  pharyngitis, vaginal infection, influenza
Neoplasms benign,             Breast cancer                    Uncommon malignant and unspecified
(including cysts and polyps)
Blood and lymphatic           Anaemia, leukopenia,             Uncommon system disorders              lymphadenopathy
Immune system disorders       Hypersensitivity                 Uncommon Laryngeal oedema,                Not Known* angioedema, urticaria
Endocrine Disorders           Hypoparathyrodism                Common Hyperparathyrodism               Uncommon
Metabolism and                Hypercalcaemia,                  Common nutrition disorders           Hyperphosphataemia
Hyperkalaemia,                   Uncommon hypocalcemia, anorexia
Psychiatric disorders         Confusional state, delirium,     Uncommon depersonalization, agitation,
insomnia, nervousness
Nervous system disorders      Headache, dysgeusia              Common Coma, cerebrovascular            Uncommon accident, transient ischemic attack, syncope, myoclonus,
hypoaesthesia, paraesthesia,
dizziness
Eye disorders                 Glaucoma, conjunctivitis         Uncommon Ear and labyrinth             Ear disorder                     Uncommon disorders
Cardiac disorders             Cardiac arrest, arrhythmia,      Uncommon atrial flutter
Vascular disorders            Hypertension, hypotension        Uncommon Respiratory, thoracic         Pulmonary oedema, asthma,        Uncommon and mediastinal               dyspnoea, epistaxis, cough disorders
Gastrointestinal              Rectal haemhorrhage,             Uncommon disorders                     colitis, diarrhoea, gastritis,
dyspepsia, dysphagia,
abdominal pain,
constipation, nausea,
vomiting, dry mouth,
gastrointestinal disorder
Gastrointestinal                 Not known haemorrhage
Skin and subcutaneous           Pruritus                         Common tissue disorders                Bullous dermatitis, alopecia,    Uncommon hirsutism, rash,
hyperhidrosis
Musculoskeletal and             Arthralgia, joint stiffness,     Uncommon connective tissue               back pain, muscle twitching,
disorders                       myalgia
Reproductive                    Breast pain, erectile            Uncommon system and breast               dysfunction disorders
General disorders              Gait disturbance, oedema,     Uncommon and administration             peripheral oedema, pain,
site conditions                injection site pain, pyrexia,
chest pain, condition aggravated, asthenia,
malaise, thirst
Investigations                 Bleeding time prolonged,      Uncommon aspartate aminotransferase increased, laboratory test abnormal, weight decreased
*Frequencies for adverse reactions from postmarketing experience cannot be estimated and have been reported as “Not known.”

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: https://sideeffects.health.gov.il.