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.