Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile

The safety profile of VIAGRA is based on 9,570 patients in 74 double blind placebo-controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness nausea, hot flush, visual disturbance, cyanopsia and vision blurred
Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.

Tabulated list of adverse reactions

In the table below all medically important adverse reactions, which occurred in clinical studies at an incidence greater than placebo are listed by system organ class and frequency (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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance


System Organ       Very           Common            Uncommon            Rare Class              common         ( 1/100 and      ( 1/1,000 and      ( 1/10,000 and ( 1/10)       <1/10)            <1/100)             <1/1,000)
Infections and                                      Rhinitis infestations

Immune system                                       Hypersensitivity disorders

Nervous system     Headache       Dizziness         Somnolence,         Cerebrovascular disorders                                           Hypoaesthesia       accident, Transient ischaemic attack,
Seizure,*
Seizure recurrence,*
Syncope


System Organ     Very       Common           Uncommon         Rare
Class            common     ( 1/100 and     ( 1/1,000 and   ( 1/10,000 and ( 1/10)   <1/10)           <1/100)          <1/1,000)
Eye disorders               Visual colour    Lacrimation      Non-arteritic distortions**    disorders***     anterior ischaemic
Visual           Eye pain,        optic neuropathy disturbance,     Photophobia,     (NAION), *
Vision blurred   Photopsia,       Retinal vascular
Ocular           occlusion,* hyperaemia,      Retinal
Visual           haemorrhage,
brightness,      Arteriosclerotic
Conjunctivitis   retinopathy,
Retinal disorder,
Glaucoma,
Visual field defect,
Diplopia,
Visual acuity reduced,
Myopia,
Asthenopia,
Vitreous floaters,
Iris disorder,
Mydriasis,
Halo vision,
Eye oedema,
Eye swelling,
Eye disorder,
Conjunctival hyperaemia,
Eye irritation,
Abnormal sensation in eye,
Eyelid oedema,
Scleral discoloration


Ear and                                      Vertigo,         Deafness labyrinth                                    Tinnitus disorders

Cardiac                                      Tachycardia,     Sudden cardiac disorders                                    Palpitations     death,* Myocardial infarction,
Ventricular arrhythmia,*
Atrial fibrillation,
Unstable angina


System Organ       Very         Common           Uncommon           Rare Class              common       ( 1/100 and     ( 1/1,000 and     ( 1/10,000 and ( 1/10)     <1/10)           <1/100)            <1/1,000)
Vascular                        Flushing,        Hypertension,
disorders                       Hot flush        Hypotension

Respiratory,                    Nasal            Epistaxis,         Throat tightness, thoracic and                    congestion       Sinus congestion   Nasal oedema, mediastinal                                                         Nasal dryness disorders

Gastrointestinal                Nausea,          Gastro             Hypoaesthesia oral disorders                       Dyspepsia        oesophagael reflux disease,
Vomiting,
Abdominal pain upper,
Dry mouth

Skin and                                         Rash               Stevens-Johnson subcutaneous                                                        Syndrome (SJS), * tissue disorders                                                    Toxic Epidermal Necrolysis (TEN) *

Musculoskeletal                                  Myalgia,
and connective                                   Pain in tissue disorders                                 extremity

Renal and                                        Haematuria urinary disorders
Reproductive                                                        Penile system and                                                          haemorrhage, breast disorders                                                    Priapism,* Haematospermia,
Erection increased


General                                          Chest pain,        Irritability disorders and                                    Fatigue,
administration                                   Feeling hot site conditions

Investigations                                   Heart rate increased

*Reported during post-marketing surveillance only
**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased 
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/