Ciprobay Adverse Reactions

Summary of the safety profile: Adverse drug reactions (ADRs) based on all clinical studies with ciprofloxacin (oral, parenteral) sorted by CIOMS III categories of frequency are listed as follows (overall n = 51621).
Tabulated list of adverse reactions: The frequencies of ADRs reported with Ciprofloxacin (Ciprobay) are summarized in the following table. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as: 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).
The ADRs identified only during post marketing surveillance, and for which a frequency could not be estimated, are listed under 'not known'. (See Table 7.)

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In isolated instances, some serious adverse drug reactions may be long-lasting (> 30 days) and disabling; such as tendinitis, tendon rupture, musculoskeletal disorders, and other reactions affecting the nervous system including psychiatric disorders and disturbance of senses.
The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment: See Table 8.

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The MedDRA preferred term is used to describe a certain reaction and its synonyms and related conditions. ADR term representation is based on MedDRA version 14.0 (except for 'Mycotic Superinfections' and 'Unspecific Pain').
Additional information on special populations: Pediatric population: The incidence of arthropathy (arthralgia, arthritis), mentioned previously, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see Precautions).