Adverse reactions : תופעות לוואי

4.8         Undesirable effects

Summary of the safety profile
The most commonly reported adverse reactions in patients taking CIALIS for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of CIALIS. The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with CIALIS once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

Tabulated summary of adverse reactions

The table below lists the adverse reactions observed from spontaneous reporting and in placebo- controlled clinical trials (comprising a total of 8022 patients on CIALIS and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

Frequency convention: 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) and very rare (<1/10,000) and not known (cannot be estimated from the available data).



Very common                Common               Uncommon                  Rare           Not known 

Immune system disorders
Hypersensitivity       Angioedema2 reactions
Nervous system disorders
Headache                 Dizziness              Stroke1 (including haemorrhagic events), Syncope,
Transient ischaemic attacks1, Migraine2,
Seizures2,
Transient amnesia
Eye disorders
Blurred vision,        Visual field defect,   Central
Sensations described   Swelling of eyelids,   serous as eye pain            Conjunctival           chorioretino hyperaemia, Non-       pathy arteritic anterior ischemic optic neuropathy
(NAION)2, Retinal vascular occlusion2
Ear and labyrinth disorders
Tinnitus               Sudden hearing loss
Cardiac disorders1
Tachycardia,           Myocardial
Palpitations           infarction, Unstable angina pectoris2,
Ventricular arrhythmia2
Vascular disorders
Flushing               Hypotension3,
Hypertension
Respiratory, thoracic and mediastinal disorders
Nasal congestion        Dyspnoea, Epistaxis
Gastrointestinal disorders
Dyspepsia               Abdominal pain,
Vomiting, Nausea,
Gastro-oesophageal reflux
Skin and subcutaneous tissue disorders
Rash                  Urticaria,
Stevens-Johnson syndrome2,
Exfoliative dermatitis2,
Hyperhydrosis
(sweating)
Musculoskeletal, connective tissue and bone disorders
Back pain,
Myalgia, Pain in extremity
Renal and urinary disorders
Haematuria
Reproductive system and breast disorders

Prolonged erections        Priapism, Penile haemorrhage,
Haematospermia
General disorders and administration site conditions
Chest pain1, Peripheral       Facial oedema2,
oedema, Fatigue               Sudden cardiac death1, 2

(1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4).
(2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.
(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products.

Description of selected adverse reactions

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.

Other special populations

Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.

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