Fosrenol Adverse Reactions

The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimized by taking Fosrenol with food and generally abated with time with continued dosing (see Dosage & Administration).
The following convention was used for frequency of adverse drug reactions: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). (See table.)

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Post marketing experience: During post-approval use of Fosrenol, cases of allergic skin reactions (including skin rashes, urticaria and pruritus) have been reported which show a close temporal relationship to lanthanum carbonate therapy. In clinical trials, allergic skin reactions were seen in both Fosrenol and placebo/active comparator groups at a frequency of very common (≥1/10).
Although there have been a number of additional isolated reactions reported, none of these reactions are considered unexpected in this patient population.
Transient QT changes have been observed but these were not associated with an increase of cardiac adverse events.
Paediatric population: Frequency, type and severity of adverse reactions in children have not been fully established. In particular, uncertainty exists on the accumulation in bone and risk of growth retardation with treatment in children.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.