What is the most important information I should know about ciprofloxacin?

• Tendon problems can happen in people of all ages who take ciprofloxacin.Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
  
  • pain
  • swelling
  • tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites.
• The risk of getting tendon problems while you take ciprofloxacin is higher if you:
  • are over 60 years of age
  • are taking steroids (corticosteroids)
  • have had a kidney, heart or lung transplant.
• Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin.
• Other reasons that can increase your risk of tendon problems can include:
  • physical activity or exercise
  • kidney failure
  • tendon problems in the past, such as in people with rheumatoid arthritis (RA).
• Stop taking ciprofloxacin immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.
• Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin. Tendon ruptures can happen within hours or days of taking ciprofloxacin and have happened up to several months after people have finished taking their fluoroquinolone.
• Stop taking ciprofloxacin immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • hear or feel a snap or pop in a tendon area
  • bruising right after an injury in a tendon area
  • unable to move the affected area or bear weightThe tendon problems may be permanent.

• pain
• burning
• tingling
• numbness
• weaknessCiprofloxacin may need to be stopped to prevent permanent nerve damage.

• seizures
• hear voices, see things, or sense things that are not there (hallucinations)
• feel restless or agitated
• tremors
• feel anxious or nervous
• confusion
• depression
• reduced awareness of surroundings
• trouble sleeping
• nightmares
• feel lightheaded or dizzy
• feel more suspicious (paranoia)
• suicidal thoughts or acts
• headaches that will not go away, with or without blurred vision
• memory problems
• false or strange thoughts or beliefs (delusions)The CNS changes may be permanent.

• urinary tract infection
• chronic prostate infection
• lower respiratory tract infection
• sinus infection
• skin infection
• bone and joint infection
• nosocomial pneumonia
• intra-abdominal infection, complicated
• infectious diarrhea
• typhoid (enteric) fever
• cervical and urethral gonorrhea, uncomplicated
• people with a low white blood cell count and a fever
• inhalational anthrax
• plague

• Studies of ciprofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
• Ciprofloxacin should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
• Ciprofloxacin should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections caused by a certain type of bacterial called Streptococcus pneumoniae.
• Ciprofloxacin Injection, USP is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs.
• Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin. Ciprofloxacin should not be used as the first choice of antibacterial medicine in children under 18 years of age.

• have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin. See the end of this Medication Guide for a complete list of ingredients in ciprofloxacin.
• also take a medicine called tizanidine (Zanaflex®).

• have tendon problems; ciprofloxacin should not be used in patients who have a history of tendon problems.
• have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin should not be used in patients who have a known history of myasthenia gravis
• have liver problems
• have central nervous system problems (such as epilepsy).
• have nerve problems. Ciprofloxacin should not be used in patients who have a history of a nerve problem called peripheral neuropathy
• have or anyone in your family has an irregular heartbeat, or heart attack, especially a condition called “QT prolongation”.
• have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
• have or have had seizures.
• have kidney problems. You may need a lower dose of ciprofloxacin if your kidneys do not work well.
• have diabetes or problems with low blood sugar (hypoglycemia).
• have joint problems including rheumatoid arthritis (RA)
• have trouble swallowing pills.
• are pregnant or plan to become pregnant. It is not known if ciprofloxacin will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Ciprofloxacin passes into your breast milk.
  • You should not breastfeed during treatment with ciprofloxacin and for 2 days after taking your last dose of ciprofloxacin. You may pump your breast milk and throw it away during treatment with ciprofloxacin and for 2 days after taking your last dose of ciprofloxacin.
  • If you are taking ciprofloxacin for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin.

• Ciprofloxacin and other medicines can affect each other causing side effects.
• Especially tell your healthcare provider if you take:
  • a steroid medicine.
  • an anti-psychotic medicine.
  • a tricyclic antidepressant.
  • a water pill (diuretic).
  • theophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®).
  • a medicine to control your heart rate or rhythm (antiarrhythmics).
  • an oral anti-diabetes medicine.
  • phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin Sodium®, Prompt Phenytoin Sodium®, Phenytek®).
  • cyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®).
  • a blood thinner (such as warfarin, Coumadin®, Jantoven®).
  • methotrexate (Trexall®).
  • ropinirole (Requip®).
  • clozapine (Clozaril®, Fazaclo® ODT®).
  • a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
  • sildenafil (Viagra®, Revatio®).
  • duloxetine.
  • products that contain caffeine.
  • probenecid (Probalan®, Col-probenecid®).

• Take ciprofloxacin exactly as your healthcare provider tells you to take it.
• Ciprofloxacin Injection, USP is given to you by intravenous (IV) infusion into your vein, slowly, over 60 minutes, as prescribed by your healthcare provider.
• Ciprofloxacin can be taken with or without food.
• Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
• Drink plenty of fluids while taking ciprofloxacin.
• Do not skip any doses of ciprofloxacin, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:
  • you have tendon problems. See “What is the most important information I should know about ciprofloxacin?”
  • you have nerve problems. See “What is the most important information I should know about ciprofloxacin?”
  • you have central nervous system problems. See “What is the most important information I should know about ciprofloxacin?”
  • you have a serious allergic reaction. See “What are the possible side effects of ciprofloxacin?”
  • your healthcare provider tells you to stop taking ciprofloxacin.Taking all of your ciprofloxacin doses will help make sure that all of the bacteria are killed.

• If you take too much ciprofloxacin, call your healthcare provider or get medical help right away.

What should I avoid while taking ciprofloxacin?

• Ciprofloxacin can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin affects you.
• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take ciprofloxacin, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of ciprofloxacin?

• See “What is the most important information I should know about ciprofloxacin?”
• Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin, even after only 1 dose. Stop taking ciprofloxacin and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  • hives
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faint
  • skin rash
  Skin rash may happen in people taking ciprofloxacin even after only 1 dose. Stop taking ciprofloxacin at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin.
  
• Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin. Call your healthcare provider right away if you have unexplained symptoms such as:
  • nausea or vomiting
  • stomach pain
  • fever
  • weakness
  • abdominal pain or tenderness
  • itching
  • unusual tiredness
  • loss of appetite
  • light colored bowel movements
  • dark colored urine
  • yellowing of the skin and whites of your eyes
  Stop taking ciprofloxacin and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin (a liver problem).
  
• Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
• Intestine infection(Clostridioides difficile -associated diarrhea).Clostridioidesdifficile-associated diarrhea (CDAD) can happen with many antibacterial medicines, including ciprofloxacin. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. CDAD can happen 2 or more months after you have finished your antibacterial medicine.
• Serious heart rhythm changes (QT prolongation and torsade de pointes).Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
  • who are elderly.
  • with a family history of prolonged QT interval.
  • with low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
  • who take certain medicines to control heart rhythm (antiarrhythmics).
• Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old can happen. Tell your child's healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin.
• Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking ciprofloxacin?”
• Changes in blood sugar. People who take ciprofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking ciprofloxacin, stop taking ciprofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

• nausea
• diarrhea
• changes in liver function tests
• vomiting
• rash