Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Hypertension: In clinical trials involving patients with hypertension, the most common reactions associated with doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific.
Benign prostatic hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.
The following undesirable effects have been observed and reported during treatment with doxazosin with the following frequencies: 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).
System Organ       Very    Common           Uncommon          Rare       Very Rare             Unknown Class              Common
(≥1/100 to       (≥1/1,000 to      (≥1/10,000 (<1/10,000)
(≥1/10) <1/10)           <1/100)           to
<1/1,000)

Infections and              Respiratory infestations                tract infection,
urinary tract infection

Blood and the                                                            Leukopenia, lymphatic system                                                         thrombocytopenia disorders

Immune system                               Allergic drug disorders                                   reaction

Metabolism and                              Gout, increased nutrition                                   appetite,
disorders                                   anorexia
Psychiatric                                 Agitation,
disorders                                   depression,
anxiety,
insomnia,
nervousness

Nervous system              Somnolence      Cerebrovascular              Dizziness postural, disorders                   dizziness,      accident,                    paraesthesia headache        hypoesthesia,
syncope, tremor

Eye disorders                                                            Blurred vision        Intraoperative floppy iris syndrome (see
Section 4.4)

Ear and                     Vertigo         Tinnitus labyrinth disorders

Cardiac                     Palpitation,    Angina                       Bradycardia, disorders                   tachycardia     pectoris,                    cardiac myocardial                   arrhythmias infarction

Vascular                    Hypotension,                                 Hot flushes System Organ        Very    Common          Uncommon          Rare       Very Rare              Unknown Class               Common
(≥1/100 to      (≥1/1,000 to      (≥1/10,000 (<1/10,000)
(≥1/10) <1/10)          <1/100)           to
<1/1,000)
 disorders                    postural hypotension

Respiratory,                 Bronchitis,    Epistaxis,                   Bronchospasm thoracic and                 cough,
mediastinal                  dyspnoea,
disorders                    rhinitis

Gastrointestinal             Abdominal      Constipation,
disorders                    pain,          flatulence,
dyspepsia,     vomiting,
dry mouth,     gastroenteritis nausea         diarrhoea

Hepato-biliary                              Abnormal liver               Cholestasis, disorders                                   function tests               hepatitis, jaundice 
Skin and                     Pruritus       Skin rash                    Urticaria, alopecia, subcutaneous                                                             purpura tissue disorders

Musculoskeletal,             Back pain,     Arthralgia        Muscle connective tissue            myalgia                          cramps, and bone                                                      muscle disorders                                                     weakness 
Renal and                    Cystitis,    Dysuria,            Polyuria   Increased diuresis, urinary disorders            urinary      micturition                    micturition incontinence frequency,                     disorder, nocturia haematuria

Reproductive                                Impotence                    Gynecomastia,          Retrograde system and breast                                                        priapism               ejaculation disorders

General                      Asthenia,      Pain, facial                 Fatigue, malaise disorders and                chest pain,    oedema administration               influenza-like site conditions              symptoms,
peripheral oedema
System Organ     Very    Common           Uncommon       Rare          Very Rare       Unknown Class            Common
(≥1/100 to       (≥1/1,000 to   (≥1/10,000 (<1/10,000)
(≥1/10) <1/10)           <1/100)        to
<1/1,000)

Investigations                            Weight increase


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