Factive Side Effects

Generic Name: gemifloxacin

Note: This page contains information about the side effects of gemifloxacin. Some of the dosage forms included on this document may not apply to the brand name Factive.

Not all side effects for Factive may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to gemifloxacin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by gemifloxacin (the active ingredient contained in Factive). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking gemifloxacin:

Less common
  • Rash
Rare
  • Body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chest pain or tightness
  • chills or fever
  • hives or welts
  • itching skin
  • painful or difficult urination
  • shortness of breath
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach tenderness
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • changes in urination
  • changes in vision
  • confusion
  • diarrhea
  • difficulty with breathing or swallowing
  • difficulty with chewing or talking
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • joint or muscle pain
  • muscle weakness
  • nausea or vomiting
  • numbness or tingling in the face, arms, or legs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the face, fingers, or lower legs
  • weight gain

Some of the side effects that can occur with gemifloxacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Rare
  • Acid or sour stomach
  • bad, unusual, or unpleasant taste
  • difficulty having a bowel movement (stool)
  • dizziness or lightheadedness
  • dryness or soreness of the throat
  • feeling of constant movement of self or surroundings
  • hoarseness
  • muscle aching or cramping
  • pain in the joints
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
  • trembling or shaking of the hands or feet
  • voice changes

For Healthcare Professionals

Applies to gemifloxacin: oral tablet

Gastrointestinal

Common (1% to 10%): Diarrhea (5%), nausea (3.7%), abdominal pain (up to 2.2%), vomiting (up to 1.6%)
Uncommon (0.1% to 1%): Anorexia, constipation, dry mouth, dyspepsia, flatulence, gastritis
Rare (less than 0.1%): Moniliasis, gastroenteritis, nonspecified gastrointestinal disorder
Postmarketing reports: Antibiotic-associated colitis

Dermatologic

Common (1% to 10%): Rash (up to 9.1%)
Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria
Rare (less than 0.1%): Eczema, photosensitivity/phototoxicity reaction
Postmarketing reports: Erythema multiforme, skin exfoliation

Most side effects reported during postmarketing experience were cutaneous (some were considered serious) and the majority of these were rash. Most rashes occurred in patients less than 40 years of age, in women (especially those on hormone replacement therapy), and in patients taking gemifloxacin for longer treatment durations (over 7 days).

The phototoxic potential of gemifloxacin may be dose-dependent.

Nervous system

Common (1% to 10%): Headache (4.2%), dizziness (1.7%)
Uncommon (0.1% to 1%): Insomnia (up to 1%), somnolence (up to 1%)
Rare (less than 0.1%): Nervousness, tremor, vertigo
Frequency not reported: Neurotoxicity (presenting as encephalopathy)
Postmarketing reports: Exacerbation of myasthenia gravis, peripheral neuropathy (may be irreversible)

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia (up to 1%), increased potassium (up to 0.5%), decreased albumin (0.3%), decreased sodium (up to 0.3%), decreased calcium (up to 0.2%), decreased total protein (0.1%), decreased potassium (0.1%), increased sodium (0.1%)
Rare (less than 0.1%): Increased lactate dehydrogenase, increased calcium

Hepatic

Common (1% to 10%): Increased ALT (up to 1.7%), increased AST (up to 1.3%)
Uncommon (0.1% to 1%): Increased creatine phosphokinase (up to 1%), increased alkaline phosphatase (up to 1%), increased GGT (up to 0.5%), increased total bilirubin (0.4%)

Musculoskeletal

Rare (less than 0.1%): Arthralgia, leg cramps, myalgia
Postmarketing reports: Tendon rupture

Other

Uncommon (0.1% to 1%): Taste perversion, fatigue, fungal infection
Rare (less than 0.1%): Asthenia, back pain, facial edema, flushing, hot flashes, increased nonprotein nitrogen, pain
Postmarketing reports: Facial swelling, peripheral edema

Genitourinary

Uncommon (0.1% to 1%): Genital moniliasis, genital pruritus, vaginitis
Rare (less than 0.1%): Abnormal urine

Hematologic

Uncommon (0.1% to 1%): Increased platelets (1%), decreased neutrophils (0.5%), increased neutrophils (0.5%), decreased hematocrit (0.3%), decreased hemoglobin (0.2%), decreased platelets (0.2%), decreased red blood cells (0.1%), increased hematocrit (0.1%), increased hemoglobin (0.1%), increased red blood cells (0.1%), leukopenia, thrombocythemia
Rare (less than 0.1%): Anemia, eosinophilia, granulocytopenia, bilirubinemia, thrombocytopenia
Postmarketing reports: Hemorrhage, increased international normalized ratio (INR)

Ocular

Rare (less than 0.1%): Abnormal vision
Postmarketing reports: Retinal hemorrhage

Respiratory

Rare (less than 0.1%): Dyspnea, pharyngitis, pneumonia
Frequency not reported: Bronchitis

Renal

Uncommon (0.1% to 1%): Increased blood urea nitrogen (0.3%), increased serum creatinine (0.2%)
Frequency not reported: Acute renal failure
Postmarketing reports: Renal failure

Cardiovascular

QTc interval prolongation has been reported; no cardiovascular morbidity or mortality due to QTc prolongation occurred during studies. Maximum QTc changes occurred 5 to 10 hours after administration of oral gemifloxacin (the active ingredient contained in Factive) This effect may be dose-related.

Frequency not reported: Ventricular extrasystoles
Postmarketing reports: Prolonged QT, supraventricular tachycardia, syncope, transient ischemic attack

Hypersensitivity

Postmarketing reports: Anaphylactic reaction

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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