Cipro XR

[ciprofloxacin]

In these clinical trials, the following events occurred in >= 2% of all CIPRO XR patients, regardless of drug relationship: nausea (4%), headache (3%), dizziness (2%), diarrhea (2%), vomiting (2%) and vaginal moniliasis (2%).

Adverse events, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 1% of all CIPRO XR treated patients were: nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000 mg group.

Additional uncommon events, judged by investigators to be at least possibly drug-related, that occurred in less than 1% of CIPRO XR treated patients were:

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BODY AS A WHOLE: abdominal pain, asthenia, malaise, photosensitivity reaction

CARDIOVASCULAR: bradycardia, migraine, syncope

DIGESTIVE: anorexia, constipation, dry mouth, flatulence, liver function tests abnormal, thirst

HEMIC/LYMPHATIC: prothrombin decrease

CENTRAL NERVOUS SYSTEM: abnormal dreams, depersonalization, depression, hypertonia, incoordination, insomnia, somnolence, tremor, vertigo

METABOLIC: hyperglycemia

SKIN/APPENDAGES: dry skin, maculopapular rash, pruritus, rash, skin disorder, urticaria, vesiculobullous rash

SPECIAL SENSES: diplopia, taste perversion

UROGENITAL: dysmenorrhea, hematuria, kidney function abnormal, vaginitis

The following additional adverse events, some of them life threatening, regardless of incidence or relationship to drug, have been reported during clinical trials and from worldwide post-marketing experience in patients given ciprofloxacin (includes all formulations, all dosages, all drug-therapy durations, and all indications). Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or a causal relationship to drug exposure. The events in alphabetical order are:

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