Adverse reactions : תופעות לוואי

4.8.    Undesirable effects
Hytrin in common with other alpha-adrenoceptor blockers may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive agent.

In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of tachycardia with heart rates of 120 to 160 beats per minute.

If syncope occurs the patient should be placed in a recumbent position and supportive treatment applied as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent their recurrence.

These adverse effects are self limiting and in most cases do not recur after the initial period of therapy or during subsequent re-titration.

Adverse drug effects reported with terazosin from multiple sources including clinical trials and spontaneous reports:

System Organ Class         Frequency                  Adverse reaction Blood and lymphatic        Not known                  Thrombocytopenia system disorder
Immune system              Not known                  Anaphylactoid reaction disorders
Psychiatric disorders      Not known                  Depression, nervousness, anxiety, insomnia
Nervous system             Not known                  Dizziness, somnolence, disorders                                             headache, paraesthesia, vertigo
Eye disorders              Not known                  Blurred vision, amblyopia, visual impairment,
conjunctivitis
Ear and labyrinth          Not known                  Tinnitus disorders
Cardiac disorders          Not known                  Palpitations, tachycardia, arrhythmia, atrial fibrillation
Vascular disorders         Not known                  Postural hypotension, syncope, vasodilatation
Respiratory, thoracic     Not known        Nasal congestion,
and mediastinal                            rhinitis, dyspnoea,
disorders                                  sinusitis, bronchitis,
epistaxis, flu symptoms,
pharyngitis, cold symptoms, cough
Gastrointestinal          Not known        Nausea, abdominal pain,
disorders                                  constipation, diarrhoea,
dry mouth, dyspepsia,
flatulence, vomiting


Skin and subcutaneous     Not known        Pruritus, rash,
tissue disorders                           hyperhidrosis,
angioedema
Musculoskeletal and       Not known        Back pain, pain in connective tissue                          extremity, neck pain,
disorders                                  shoulder pain, gout,
arthralgia, arthritis, joint disorders, myalgia
Renal and urinary         Not known        Pollakiuria, urinary tract disorders                                  infection and urinary incontinence (primarily reported in post- menopausal women)
Reproductive system       Not known        Libido decreased,
and breast disorders                       erectile dysfunction,
priapism
General disorders and     Not known        Asthenia, peripheral administration site                        oedema, oedema, chest conditions                                 pain, face oedema,
pyrexia
Investigations            Not known        Weight increased.
Decreased haematocrit,
decreased haemoglobin,
decreased white blood cell count, decreased total protein and decreased blood albumin
(suggestive of haemodilution)
Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen
(PSA) levels.

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/