Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebo-controlled randomised clinical trials in adults evaluating a 5% foam formulation.
Adverse drug reactions (ADRs) identified during clinical trials and post- marketing experience with minoxidil are included in the table below by System Organ Class (SOC).

The frequencies are provided according to the following convention: Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000, including isolated reports
Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

Body System                Frequency             Adverse Drug
(SOC)                                            Reaction
(Preferred
Term)
Immune System             Common                Hypersensitivity
Disorders                                       reactions (including face oedema,
generalised erythema,
pruritus generalised,
swelling face, and throat tightness)


Not known             Angioedema (including lip oedema, lip swelling, oedema mouth, oropharyngeal swelling, pharyngeal oedema, swollen tongue and tongue
oedema)

Psychiatric Disorders   Not known     Depressed mood
Nervous System          Very common   Headache
Disorders
Uncommon      Dizziness

Eye disorders           Not known     Eye irritation
Cardiac disorders       Common        Chest pain

Uncommon      Palpitations

Not known     Heart rate increased
Vascular disorders      Not known     Hypotension

Respiratory, thoracic   Uncommon      Dyspnoea and mediastinal disorders
Gastrointestinal        Uncommon      Nausea
Disorders
Not known     Vomiting

Skin and subcutaneous   Common        Hypertrichosis tissue disorders                      (unwanted non-scalp hair including facial hair growth in women)
Pruritus (including rash pruritic generalised and eye pruritus)
Rash (including pustular, papular,
generalised, vestibular and macular rash)
Dermatitis (including contact, allergic, atopic and seborrhoeic dermatitis)
Rare          Changes in hair texture
Not known            Dry skin
Skin exfoliation
(including exfoliative rash and dermatitis exfoliative)
Acne (acneiform rash)
Temporary hair loss
(see section 4.4)
Changes in hair colour

General disorders and     Common               Oedema peripheral administration site conditions                Not known            Application site reactions (These sometimes involve nearby structures like the ears and face and typically consist of pruritus, irritation,
pain, rash, oedema, dry skin, erythema and rash erythematous but can sometimes be more severe and include exfoliation, dermatitis,
blistering, bleeding and ulceration)

Investigations            Common               Weight 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 Side effects can also be reported to the following email: safety@trima.co.il