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, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), 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 (SOC)             Frequency                 Adverse Drug Reaction (Preferred Term)
Immune System Disorders       Common                    Hypersensitivity 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 Disorders Very common                    Headache
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 and    Uncommon                  Dyspnoea mediastinal disorders
Gastrointestinal Disorders   Uncommon                  Nausea
Not known                 Vomiting
Skin and subcutaneous        Common                    Hypertrichosis (unwanted non-scalp tissue disorders                                       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          Not known                 Application site reactions (These conditions                                             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 Additionally, you can also report to Padagis.co.il.