Cialis ® (tadalafil)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Cialis Summary of Product Characteristics (SmPC)

Cialis® (tadalafil): Undesirable effects

The most commonly reported adverse reactions were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of Cialis.

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), Very Rare (<1/10,000) and Not known (cannot be estimated from the available data).

Very common

Common

Uncommon

Rare

Immune system disorders



Hypersensitivity reactions

Angioedema2

Nervous system disorders


Headache

Dizziness

Stroke1 (including haemorrhagic events), Syncope,

Transient ischaemic attacks1,

Migraine2, Seizures2, Transient amnesia

Eye disorders



Blurred vision, Sensations described as eye pain

Visual field defect, Swelling of eyelids, Conjunctival hyperaemia, Non- arteritic anterior ischaemic optic neuropathy (NAION)2, Retinal vascular occlusion2

Ear and labyrinth disorders



Tinnitus

Sudden hearing loss


Very common

Common

Uncommon

Rare

Cardiac disorders1



Tachycardia, Palpitations

Myocardial 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 oedema, Fatigue

Facial oedema2, 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. Healthcare professionals are asked to report any suspected adverse reactions via United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

REFERENCE

Cialis [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.

Date of Last Review: September 26, 2018


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