ACC

ACC Adverse Reactions

acetylcysteine

Manufacturer:

Hermes

Distributor:

Sandoz
Full Prescribing Info
Adverse Reactions
The evaluation of adverse reactions is based on the following information on frequencies: Very common: (≥1/10); Common: (≥1/100 up to <1/10); Uncommon: (≥1/1,000 up to <1/100); Rare: (≥1/10,000 up to <1/1,000); Very rare: (<1/10,000); Not known: (cannot be estimated from the available data).
Immune system disorders: Uncommon: Hypersensitivity reactions. Very rare: Anaphylactic shock, anaphylactic/anaphylactoid reactions.
Nervous system disorders: Uncommon: Headache.
Ear and labyrinth disorders: Uncommon: Tinnitus.
Cardiac disorders: Uncommon: Tachycardia.
Vascular disorders: Uncommon: Hypotension. Very rare: Hemorrhage.
Respiratory, thoracic and mediastinal disorders: Rare: Dyspnoea, bronchospasm.
Gastrointestinal disorders: Uncommon: Nausea, vomiting, diarrhea, abdominal pain. Rare: Dyspepsia.
Skin and subcutaneous tissue disorders: Uncommon: Urticaria, rash, angioedema, itching, exanthema.
General disorders and administration site conditions: Uncommon: Fever. Not known: Facial edema.
Investigations: Uncommon: Hypotension.
In very rare cases, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine, In most of these reported cases, at least one additional drug that could potentially have intensified the described mucocutaneous effects was being taken at the same time.
If skin or mucous membrane abnormalities develop, medical advice should therefore immediately be sought and the use of acetylcysteine discontinued.
A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by different studies. The clinical relevance has not yet been clarified to date.
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