Minoxidil

Topical drugs, such as corticosteroids, tretinoin or dithranol or petrolatum which alter the stratum corneum barrier, could result in increased absorption of minoxidil if applied concurrently.

Guanethidine has been reported to interact with oral formulations of minoxidil resulting in rapid and pronounced lowering of blood pressure. There is a theoretical possibility that topical minoxidil may also interact with guanethidine.

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using this product.

There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown a risk to the foetus at exposure levels that are very high compared to those intended for human exposure. There is potentially a risk of foetal harm in humans.

Systemically absorbed minoxidil is secreted in human milk. The effect of minoxidil on newborns/infants is unknown.

This product may cause dizziness or hypotension. If affected, patients should not drive or operate machinery.

The safety of topical minoxidil from clinical trials 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 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’.

Immune System Disorders

Common: Hypersensitivity reactions (The manifestations of Hypersensitivity reactions may include the following MedDRA PTs: Face oedema, Generalised erythema, Pruritus generalized, Swelling face, and Throat tightness)

Not known: Angioedema (The manifestations of angioedema may include following PTs: 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 mediastinal disorders

Uncommon: Dyspnoea

Gastrointestinal Disorders

Uncommon: Nausea

Not known: Vomiting

Skin and subcutaneous tissue disorders

Common: Hypertrichosis (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, Changes in hair colour

General disorders and administration site conditions

Common: Oedema peripheral

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