Vesanoid Adverse Reactions

In patients treated with the recommended daily doses of tretinoin the most frequent undesirable effects are consistent with the signs and symptoms of the hypervitaminosis A syndrome, which tretinoin shares with other retinoids.
The adverse reactions listed in the table as follows have been reported in pivotal clinical studies and during the post-marketing period.
Adverse reactions are presented by MedDRA System Organ Class and frequency (very common (≥1/10)). Adverse reactions reported during the post-marketing period are also included in the table under the frequency category "not known" (cannot be estimated from the available data). (See table.)

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The decision to interrupt or continue therapy should be based on an evaluation of the benefit of the treatment versus the severity of the side-effects.
Description of selected adverse reactions: Differentiation syndrome (formerly known as retinoic acid syndrome) may be fatal and is characterised by fever, dyspnoea, acute respiratory distress, pulmonary infiltrates, pleural and pericardial effusions, hypotension, oedema, weight gain, hepatic, renal and multi-organ failure. Differentiation syndrome is frequently associated with hyperleukocytosis. For prevention and treatment of differentiation syndrome (see Precautions).
Leukocytosis/hyperleukocytosis are frequent adverse effects associated with tretinoin therapy of APL and may be accompanied by differentiation syndrome. However, most cases of leukocytosis/hyperleukocytosis are not associated with a differentiation syndrome.
In clinical trials increased frequencies of hyperleukocytosis, QTc prolongation and hepatotoxic effects have been observed with the combination therapy of tretinoin with arsenic trioxide compared to tretinoin/chemotherapy combination. Liver toxicity occurred predominantly during the first phase of therapy (induction therapy) and is mainly characterised by increase in transaminases. For the characteristics, prevention, and treatment of hyperleukocytosis, QTc prolongation and hepatotoxic effects (see Precautions).
Teratogenicity: See Use in Pregnancy & Lactation and Warnings.
Paediatric population: There is limited safety information on the use of tretinoin in children. There have been some reports of increased toxicity in children treated with tretinoin, particularly increased pseudotumour cerebri.