Adverse reactions : תופעות לוואי

4.8 Undesirable effects


As all paracetamol products, adverse drug reactions are rare (>1/10000, <1/1000) or very rare (<1/10000), they are described below:

Organ system         Rare                 Very rare           Isolated reports2
>1/10000,            <1/10000
<1/1000
General              Malaise              Hypersensitivit y reaction
Cardiovascular       Hypotension          Shock2
Liver                Increased levels of hepatic transaminases
Blood and the        Agranulocytosis, Leucopenia lymphatic system     neutropenia2 disorders2                            Thrombocytop enia
Neurological 2                        Neurological            Coma2
disorders2
Renal/Genitourin                           Acute renal ary2                                       failure2
Skin and              Macular rash,        Maculo-            Lyell subcutaneous          injection site       papular rash,      Syndrome2 tissue disorders2     reaction2            pemphigoid reaction,
pustular rash2

Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation).

Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment.


Post Market Adverse Effects for Propacetamol/Paracetamol2
The following adverse events have also been reported during postmarketing surveillance, but incidence rate (frequency) is not known.

Organ System                                    Adverse Event
Blood and the lymphatic system                  - Thrombocytopenia disorders

Cardiac disorders                               - Tachycardia
Gastrointestinal disorders                  - Nausea
- Vomiting

General disorders and administration            - Administration site reaction site conditions

Hepatobiliary disorders                     - Fulminant hepatitis
- Hepatic necrosis
- Hepatic failure
- Hepatic enzymes increased
Immune system disorders                         - Angioneurotic (Quincke’s) edema - Anaphylactic shock
- Anaphylaxis
- Hypersensitivity reactions (ranging from simple skin rash or urticaria to anaphylactic shock) have been reported and require the discontinuation of treatment



Skin and subcutaneous tissue                    - Erythema disorders                                       - Flushing
- Pruritus
- Rash
- Urticaria
- Acute generalised exanthematous pustulosis
- Toxic epidermal necrolysis
- Stevens-Johnson syndrome