... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro (ciprofloxacin hydrochloride) Prescribing Information Fluoroquinolone Antimicrobial Drugs-- Cipro (ciprofloxacin hydrochloride) Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-April 2009 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Brand (Generic) Name Sections Modified Cipro (ciprofloxacin hydrochloride) Tablets Cipro ...

... Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Drugs Home >Drugs >Drug Safety and Availability >Postmarket Drug Safety Information for Patients and Providers Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Approved Risk Evaluation and Mitigation Strategies (REMS) Postmarketing Safety Evaluation of New Molecular Entities: Final Report Drug Safety Information for Healthcare Professionals-FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Potential Contamination Updated June 1, 2010 On May 29, 2010, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals not to use certain intravenous bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Foreign matter should not be present in a sterile injectable product. Potentially affected products are sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. Healthcare professionals ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Fluoroquinolone Antimicrobial Drugs-- Proquin XR (ciprofloxacin HCl extended-release) Tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-April 2009 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Brand (Generic) Name Sections Modified Proquin XR (ciprofloxacin HCl extended-release) Tablets MEDICATION GUIDE â ...

... Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA Patient Safety News: Show #80, October 2008 FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. Fluoroquinolones include Cipro (ciprofloxacin ), Factive (gemifloxacin ), Levaquin (levofloxacin ), Avelox (moxifloxacin ), Noroxin (norfloxacin ), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride). FDA is concerned that large numbers of tendon problems were continuing to be reported, despite a warning that already appears in the labeling for these drugs. The boxed warning is being added to draw the practitioner's attention to this information. This can also affect the benefit-risk decisions that are made when these drugs are prescribed. Certain patients are at greater risk for these injuries, including those over 60, those taking corticosteroids, and patients who have had heart, lung or kidney transplants. Certain tendons are also more likely to be affected. The Achilles is the most commonly affected, but ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro XR (ciprofloxacin extended-release tablets) Prescribing Information Jan 2008-- Cipro XR (ciprofloxacin extended-release tablets) Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified PRECAUTIONS Photosensitivity / Phototoxicity Moderate to severe photosensitivity / phototoxicity reactions, the latter of which may ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro (ciprofloxacin) Prescribing Information and Medication Guide Oct 2008 Fluoroquinolone Antimicrobial Drugs-- Cipro (ciprofloxacin) Prescribing Information and Medication Guide Oct 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-October 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro (ciprofloxacin hydrochloride) Tablets and Oral Suspension Prescribing Information Jan 2008-- Cipro (ciprofloxacin) Oral Suspension Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified PRECAUTIONS Photosensitivity / Phototoxicity Moderate to severe photosensitivity / phototoxicity reactions, the latter of which ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro (ciprofloxacin) Prescribing Information and Medication Guide Oct 2008 Fluoroquinolone Antimicrobial Drugs-- Cipro I.V. (ciprofloxacin) for Intravenous Infusion October 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-October 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro I.V. (ciprofloxacin) For Intravenous Infusion Prescribing Information Jan 2008-- Cipro I.V. (ciprofloxacin) For Intravenous Infusion Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified PRECAUTIONS Photosensitivity / Phototoxicity Moderate to severe photosensitivity / phototoxicity reactions, the ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Cipro (ciprofloxacin) Prescribing Information and Medication Guide Oct 2008 Fluoroquinolone Antimicrobial Drugs-- Cipro (ciprofloxacin) Oral Suspension October 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-October 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of Changes to Contraindications ...