The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.
Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages. Available published data do not contraindicate breastfeeding.
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency. The following convention has been utilized for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimed from available data). Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.
Post Marketing Data
|Body System||Undesirable Effects||Frequency|
|Blood and lymphatic system disorders
|Immune System disorders
||Anaphylaxis, cutaneous hypersensitivity reactions including, among others, skin rashes, angioedema, Stevens -Johnson syndrome and Toxic Epidermal Necrolysis.||Very rare|
|Respiratory, thoracic and mediastinal disorders||Bronchospasm in patients sensitive to aspirin and other NSAIDs||Very rare|
|Hepatobiliary disorders||Hepatic dysfunction||Very rare|