Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimised by taking Fosrenol with food and generally abated with time with continued dosing (see section 4.2).
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).

Infections and Infestations

Uncommon                                       Gastroenteritis, laryngitis 
Blood and lymphatic system disorders

Uncommon                                       Eosinophilia
Endocrine disorders
Uncommon                                 Hyperparathyroidism

Metabolism and nutrition disorders

Common                                   Hypocalcaemia
Uncommon                                 Hypercalcaemia, hyperglycaemia, hyperphosphataemia, hypophosphataemia,
anorexia, appetite increased

Nervous system disorders

Very Common                              Headache
Uncommon                                 Dizziness, taste alteration

Ear and Labyrinth disorders

Uncommon                                 Vertigo
Gastrointestinal disorders

Very Common                              Abdominal      pain,     diarrhoea,   nausea, vomiting

Common                                   Constipation, dyspepsia, flatulence 
Uncommon                                 Ileus, Subileus, intestinal obstruction, irritable bowel syndrome, oesophagitis,
stomatitis, loose stools, indigestion,
gastrointestinal disorder (Not otherwise specified), dry mouth, tooth disorder,
eructation

Rare                                     Intestinal perforation

Skin and subcutaneous tissue disorders
Uncommon                                 Alopecia, sweating increased 
Musculoskeletal and connective tissue disorders

Uncommon                                 Arthralgia, myalgia, osteoporosis 
General disorders and administration site conditions
Uncommon                                   Asthenia, chest pain, fatigue, malaise, peripheral oedema, pain, thirst

Investigations

Uncommon                                   Blood aluminium increased, increase in GGT, increases in hepatic transaminases,
alkaline phosphatase increased, weight decrease.

Not known                                  Product residue present1
1
See Lanthanum deposition in gastrointestinal mucosa warning in section 4.4 

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.
Reporting of suspected adverse reactions
Side effects can be reported to the Ministry of Health by clicking on the link “Adverse Drug Reactions Repot” that appears on the home page of the Ministry of Health web site (www.health.gov.il), which leads to an online form for reporting side effects.
Alternatively, you can use the following link:
/https://sideeffects.health.gov.il