Factive Adverse Reactions

Clinical Trials Experience: In clinical studies, 8,119 patients received daily oral doses of 320 mg FACTIVE. In addition, 1,797 healthy volunteers and 81 patients with renal or hepatic impairment received single or repeat doses of FACTIVE in clinical pharmacology studies.
Adverse Events with a Frequency of Greater than or Equal to 1%: The most commonly reported adverse events for patients receiving FACTIVE were diarrhea (5.0%), headache (4.2%), nausea (3.7%), rash (3.5%), abdominal pain (2.2%), dizziness (1.7%), and vomiting (1.6%).
Adverse Events with a Frequency of Less than 1%: Additional adverse events in the 8,119 patients included: Blood and Lymphatic System Disorders: Thrombocythemia.
Gastrointestinal Disorders: Abdominal pain, constipation, dry mouth, dyspepsia, flatulence, gastritis, vomiting.
*General Disorders and Administration Site Conditions: Fatigue.
Infections and Infestations: Fungal infection.
Laboratory investigations: Increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased alkaline phosphatase (ALP), increased creatinine phosphokinase (CPK).
Metabolism and Nutrition Disorders: Anorexia, hyperglycemia.
*Nervous System Disorders: Dizziness, taste perversion.
*Psychiatric Disorders: Insomnia, somnolence.
Reproductive System and Breast Disorders: Moniliasis genital, genital pruritus, vaginitis.
Skin and Subcutaneous Tissues Disorders: Dermatitis, pruritus, urticarial.
Other adverse reactions considered to have a suspected relationship to the drug that occurred in ≤0.1% of patients included: Blood and Lymphatic System Disorders: Anemia, eosinophilia, granulocytopenia, thrombocythemia.
*Ear and Labyrinth Disorders: Vertigo.
*Eye Disorder: Abnormal vision.
Gastrointestinal Disorders: Gastroenteritis, non-specified gastrointestinal disorder.
*General Disorders and Administration Site Conditions: Asthenia, facial edema, hot flashes, pain.
Infections and Infestations: Moniliasis, pharyngitis, pneumonia.
Laboratory investigations: Abnormal urine, gamma-glutamyltransferase (GGT) increased, increased non-protein nitrogen (NPN).
Metabolism and Nutrition Disorders: Bilirubinemia.
*Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, leg cramps, myalgia.
*Nervous System Disorders: Dizziness, tremor.
*Psychiatric Disorders: Insomnia, nervousness, somnolence.
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea.
Skin and Subcutaneous Tissues Disorders: Eczema, flushing, photosensitivity/phototoxicity reactions.
*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendinitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of fluoroquinolones in some cases irrespective of pre-existing risk factors (see Warnings and Precautions).
Post-Marketing Experience: The majority of the post-marketing adverse events reported were cutaneous and most of these were rash. Some of these cutaneous adverse events were considered serious. The majority of the rashes occurred in women and in patients under 40 years of age.
Post-Marketing Surveillance: Post-marketing surveillance of FACTIVE conducted in 3,972 patients over the past 6 years in Korea, occurrence rate of adverse events was reported to be 0.9% (34 patients/3,972 patients). The reported adverse events include eight cases of upper abdominal pain (0.2%) and rash (0.2%) respectively, five cases of nausea (0.1%), four cases of urticaria (0.1%), three cases of pruritus (0.1%), two cases of headache (0.1%) and dizziness (0.1%) respectively, and nine individual cases of myalgia, vomiting, constipation, diarrhea, dyspepsia, stomatitis, chest pain, insomnia, and otomycosis. All adverse events and their relationship to the drug cannot be entirely excluded. Among the reported adverse events, serious adverse event includes a single case of generalized rash and unexpected adverse reactions include five individual cases of myalgia, chest pain, abdominal distress, stomatitis, and otomycosis.
Post-Marketing Spontaneous Reporting: Following adverse events have been additionally reported during post-marketing use of FACTIVE. Since these events are reported spontaneously from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Peripheral neuropathy that may be irreversible; Anaphylactic reaction, erythema multiforme, skin exfoliation, facial swelling, pharyngeal swelling, Peripheral edema; Exacerbation of myasthenia gravis; Hemorrhage Increase of International Normalization Rate (INR), retinal hemorrhage; Renal failure; Prolonged QT, supraventricular tachycardia, syncope, transient ischemic attack; Photosensitivity/phototoxicity reaction; Antibiotic-associated colitis; Tendon rupture.