Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of the safety profile
The most frequent and very common adverse reactions related to midodrine hydrochloride therapy are piloerection, pruritus of the scalp and dysuria.


Tabulated list of adverse reactions
Organ Class    Very           Common            Uncomm       Rare         Frequency Common         (> 1/100, <       on           (>           not known (> 1/10)       1/10)             (>           1/10,000,    (cannot be 1/1,000,     <            estimated
< 1/100)     1/1,000)     from available data)
Psychiatric                                     Sleep                     Anxiety disorders                                       disorders                 Confusional Insomnia                  state
Nervous                       Paraesthesia      Restlessn system                        Paraesthesia of   ess disorders                     the scalp         Excitabilit
Headache          y
Irritability
Cardiac                                         Reflex       Tachycar disorders                                       bradycard dia ia           Palpitatio ns
Vascular                      Supine disorders                     hypertension
(dose dependent effect)
Gastrointest                  Nausea                                      Abdominal inal                          Dyspepsia                                   pain disorders                     Stomatitis                                  Vomiting Diarrhoea
Hepatobiliar                                                 Abnormal y disorders                                                  hepatic function
Raised liver enzymes
Skin and       Piloerection   Pruritus subcutaneou    (goose         Chills s tissue       bumps)         Flushing disorders      Pruritus of    Rash the scalp
Renal and      Dysuria        Urinary           Urinary
Urinary                       retention         urgency disorders


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.