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Home >> Patients >Possible side effects

Possible Side Effects

Who should not take FACTIVE?

Do not take FACTIVE, if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in FACTIVE. Ask your healthcare provider if you are not sure.

What should I avoid while taking FACTIVE?

FACTIVE 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 FACTIVE affects you.

What are the possible side effects of FACTIVE?

Most people who take FACTIVE do not have major side effects. The most common side effects, which are usually mild, include rash, diarrhea, nausea, headache, abdominal pain, vomiting and dizziness.

FACTIVE belongs to a class of antibiotics called fluoroquinolones. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take FACTIVE.

The most common side effects of FACTIVE

  • Diarrhea
  • Rash
  • Nausea
  • Headache
  • Stomach pain
  • Vomiting
  • Dizziness

Tendon rupture or swelling of the tendon (tendinitis)

  • Tendons are tough cords of tissue that connect muscles to bones.
  • Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including FACTIVE.

The risk of getting tendon problems is higher if you:

  • Are over 60 years of age
  • Are taking steroids (corticosteroids)
  • Have had a kidney, heart or lung transplant.
  • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
  • Other reasons for tendon ruptures
  • Physical activity or exercise
  • Kidney failure
  • Tendon problems in the past, such as in people with rheumatoid arthritis (RA).
  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking FACTIVE until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. 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. Talk to your healthcare provider about the risk of tendon rupture with continued use of FACTIVE. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking FACTIVE. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • 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 weight

Central Nervous System Effects.

Seizures have been reported in people who take fluoroquinolone antibiotics, including FACTIVE. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking FACTIVE will change your risk of having a seizure. Central Nervous System (CNS) side effects may occur as soon as after taking the first dose of FACTIVE.

Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

  • Feel lightheaded
  • Seizures
  • Hear voices, see things, or sense things that are not there (hallucinations)
  • Feel restless
  • Tremors
  • Feel anxious or nervous
  • Confusion
  • Depression
  • Trouble sleeping
  • Feel more suspicious (paranoia)
  • Suicidal thoughts or acts
  • Nightmares

Serious allergic reactions.

Allergic reactions can happen in people taking fluoroquinolones, including FACTIVE, even after only one dose.

Stop taking FACTIVE 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
  • Yellowing of the skin or eyes. Stop taking FACTIVE and call your healthcare provider right away if you get 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 FACTIVE (a liver problem).

Skin rash.

Skin rash may happen in people taking FACTIVE. Stop taking FACTIVE 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 FACTIVE.

Rash happens more often with FACTIVE in :

  • Women, especially women who take hormone replacement therapy
  • People under 40 years of age
  • People who take FACTIVE for longer than 5 days.

Serious heart rhythm changes (QTc prolongation and torsades de pointes).

Tell your healthcare provider right away if you have a change in your heartbeat (get a fast or irregular heartbeat), or if you faint. FACTIVE 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 happening are higher in people:

  • Who are elderly
  • With a family history of prolonged QT interval
  • With low blood potassium (hypokalemia)
  • Who take certain medicines to control heart rhythm (antiarrhythmics).

Intestine infection (Pseudomembranous colitis).

Pseudomembranous colitis can happen with most antibiotics, including FACTIVE. 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. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Changes in sensation and possible nerve damage (Peripheral Neuropathy).

Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including FACTIVE.

Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

  • Pain
  • Burning
  • Tingling
  • Numbness
  • Weakness

FACTIVE may need to be stopped to prevent permanent nerve damage.

Sensitivity to sunlight (photosensitivity)

Avoid sunlamps, tanning beds, and try to limit your time in the sun. FACTIVE can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking FACTIVE, call your healthcare provider right away. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

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Important Safety Information

THE SAFETY AND EFFECTIVENESS OF FACTIVE IN CHILDREN, ADOLESCENTS (<18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components. Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including FACTIVE. Hypersensitivity reactions reported in patients receiving fluoroquinolone therapy have occasionally been fatal. These reactions may include serious, sometimes fatal skin reactions such as toxic epidermal necrolysis or Stevens-Johnson Syndrome; effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure; renal toxicities including interstitial nephritis and/or acute renal insufficiency or failure; and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. FACTIVE should be discontinued immediately at the first sign of an immediate type I hypersensitivity skin rash or any other manifestation of hypersensitivity reaction.

Fluoroquinolones, including FACTIVE, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking FACTIVE until tendinitis or tendon rupture have been ruled out, and avoid exercise and using the affected area.

Fluoroquinolones may prolong the QT interval in some patients. FACTIVE should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients receiving Class IA or Class III antiarrhythmic agents.

Rare cases of peripheral neuropathy have been reported in patients receiving quinolones.

In clinical studies with FACTIVE, central nervous system (CNS) effects have been reported infrequently. As with other fluoroquinolones, FACTIVE should be used with caution in patients with known or suspected CNS diseases. If CNS reactions occur, FACTIVE should be discontinued and appropriate measures instituted.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotic agents, including FACTIVE. If diarrhea occurs, evaluate for CDAD and treat appropriately.

In clinical trials, rash occurred more often with FACTIVE than therapy with comparator agents (2.8% vs. 0.6%). Increasing incidence of rash was associated with younger age (especially below 40), female gender, use of hormone replacement therapy, and longer duration of therapy.

Moderate to severe photosensitivity/phototoxicity reactions can be associated with the use of quinolones after sun or UV light exposure. Excessive exposure to the sun or UV light should be avoided.

Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin preparations containing zinc or other cations, or Videx® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should not be taken within 2 hours of FACTIVE.

In clinical trials, the most common adverse drug reactions (≥2%) were diarrhea, rash, nausea, headache, abdominal pain, vomiting, and dizziness.

This product is available by prescription only.

* Videx® is a registered trademark of Bristol-Myers Squibb Company.

For US residents,
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For Non-US residents,
You are encouraged to report negative side effects of prescription drugs, please click here or call 82-2-6924-3620.

Please note that the information contained on this site is intended for international health care providers and may not be appropriate for your country of origin. Please see the full FACTIVE prescribing information for your country for approved product indications, dosing, and important safety considerations. Click on the "Global Countries" tab above to learn how to obtain country-specific prescribing information.

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