Adverse reactions : תופעות לוואי

4.8      Undesirable effects
The most common reported drug reaction is diarrhoea which is usually mild and occurs more commonly with higher doses.
These adverse reactions may occur when using sodium clodronate:
System Organ          Common               Rare                   Very Rare         Frequency Class                  1/100 to < 1/10     1/10,000 to <        < 1/10,000        unknown 1/1,000
Metabolism and        Asymptomatic         Symptomatic nutrition disorders   hypocalcaemia.       hypocalcaemia.
Increased levels of serum parathyroid hormone associated with decreased serum calcium levels.
Increased levels of serum alkaline phosphatase.*

Gastrointestinal      Diarrhoea** disorders
Nausea**
Vomiting**
Hepatobiliary         Levels of            Levels of disorders             transaminases        transaminases increased –          increased to more usually within       than twice the normal range.        normal range without associated abnormal hepatic function.
Skin and                                   Hypersensitivity subcutaneous                               reaction tissue disorders                           manifesting as skin reaction e.g.
pruritus, urticaria,
exfoliative dermatitis
Respiratory,                               Bronchospasm in                          Impairment of thoracic and                               patients with and                        respiratory function mediastinal                                without a previous                       in patients with disorders                                  history of asthma.                       aspirin-sensitive asthma.
Hypersensitivity reactions manifesting as respiratory disorder.
Renal and urinary                                                                   Impairment of renal disorders                                                                           function (elevation of serum creatinine and proteinuria),
severe renal damage.
Single cases of renal failure, in rare cases with fatal outcome,
especially with concomitant use of
NSAIDs, most often diclofenac.
Musculoskeletal    Atypical            Osteonecrosis     Isolated cases of and connective     subtrochanteric     of the external   osteonecrosis of tissue disorders   and diaphyseal      auditory canal    the jaw, primarily in femoral fractures   (bisphosphonate   patients previously
(bisphosphonate     class adverse     treated with amino- class adverse       reaction).        bisphosphonates reaction; from                        such as post-marketing                        zoledronate and experience) (see                      pamidronate (see section 4.4).                         section 4.4).
Severe bone, joint and/or muscle pain has been reported in patients taking sodium clodronate.
However, such reports have been infrequent and in randomised placebo controlled studies no differences are apparent between placebo and sodium clodronate treated patients.
The onset of symptoms varied from days to several months after starting sodium clodronate.
Eye Disorders                                            Uveitis has been reported with
Sodium clodronate during post- marketing experience.
Although the following reactions have been reported with other bisphosphonates;
conjunctivitis,
episcleritis and scleritis, only conjunctivitis has been reported for
Sodium clodronate.
This was in one patient concomitantly treated with another bisphosphonate.
To date, episcleritis
and scleritis
(bisphosphonate class adverse reactions) have not been reported with
Sodium clodronate

* in patients with metastatic disease, may also be due to hepatic and bone disease.

** usually mild – use of the divided dose regimen rather than a single daily dose may improve gastro-intestinal tolerance.

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il