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Adverse reactions were assessed in clinical trials involving approximately 2500 patients receiving single-dose or multiple-dose regimens of grepafloxacin.

Multiple dose Regimens

Most of the adverse reactions reported in clinical trials were transient in nature, mild to moderate in severity, and required no treatment. Twenty of 1069 patients (1.9%) receiving grepafloxacin 400 mg daily and 50 of 925 patients (5.4%) receiving grepafloxacin 600 mg daily discontinued RAXAR (grepafloxacin) Tablets due to an adverse reaction thought by the investigator to be drug-related.

Table 3 lists adverse events that occurred with frequencies of 1% or greater. These events were thought by the investigators to be drug-related in patients treated with grepafloxacin in multiple dose clinical trials.

Table 3
Drug-related Adverse Reactions in Grepafloxacin Treated Patients on Multiple dose Dosing Regimens in Clinical Trials

Adverse Reaction
400 mg daily (n=1069)
600 mg daily (n=925)
Nausea
11.1 %
15.8 %
Taste perversion
9.0 %
17.8 %
Headache
4.6 %
4.9 %
Dizziness
4.3 %
5.4 %
Diarrhea
3.5 %
4.2 %
Vaginitis
3.3 %
1.4 %
Abdominal pain
2.2 %
2.1 %
Vomiting
1.7 %
5.7 %
Pruritus
1.6 %
1.2 %
Dyspepsia
1.5 %
3.1 %
Leukorrhea
1.4 %
0.0 %
Asthenia
1.4 %
2.3 %
Infection
1.3 %
0.4 %
Insomnia
1.3 %
2.1 %
Rash
1.1 %
1.9 %
Anorexia
0.8 %
1.8 %
Somnolence
1.0 %
1.5 %
Dry mouth
0.8 %
1.1 %
Photosensitivity reaction
0.7 %
1.8 %
Constipation
0.7 %
2.2 %
Pain
0.6 %
1.0 %
Nervousness
0.6 %
1.7 %

Additional drug-related events, occurring in multiple-dose clinical trials at a rate of less than 1% were:

Body as a Whole: Back pain, body odor, chest pain, chills, facial edema, fever, malaise, neck rigidity, pelvic pain.

Cardiovascular System: Arrhythmia, hypotension, palpitations, peripheral vascular disorder, postural hypotension, syncope, tachycardia, vasodilatation.

Digestive System: Abnormal liver function tests, abnormal stools, cheilitis, dysphagia, eructation, flatulence, gastritis, gastrointestinal disorder, gingivitis, glossitis, increased appetite, melena, mouth ulceration, oral moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue discoloration, tongue disorder, tongue edema.

Hemic and Lymphatic System: Anemia, eosinophilia, hypochromic, anemia, leukocytosis, leukopenia, lymphadenopathy, lymphocytosis, lymphoma like reaction, prothrombin decreased, prothrombin increased, reticuloendothelial hyperplasia, thrombocytopenia, thromboplastin increased.

Metabolic and Nutritional System: Dehydration, edema, electrolyte abnormality, gout, hyperglycemia, hyperlipidemia, hypernatremia, hyperuricemia, increased alkaline phosphatase, increased BUN, increased creatinine, increased gamma glutamyl transpeptidase, increased SGOT, increased SGPT, peripheral edema, weight loss.

Musculoskeletal System: Arthralgia, myalgia.

Nervous System: Abnormal dreams, abnormal gait, agitation, anxiety, confusion, depression, emotional lability, hallucinations, hyperkinesia, hypesthesia, hypokinesia, paresthesia, speech disorder, stupor, thinking abnormal, tremor, vertigo.

Respiratory System: Asthma, atelectasis, bronchitis, dyspnea, epistaxis, hemoptysis, increased cough, laryngismus, pharyngitis, pleural effusion, rhinitis, sputum increased.

Skin and Appendages: Acne, alopecia, dry skin, epidermal necrolysis, exfoliative dermatitis, fungal dermatitis, herpes simplex, maculopapular rash, skin disorder, sweating, urticaria, vesiculobullous rash.

Special Senses: Amblyopia, conjunctivitis, deafness, dry eyes, ear disorder, eye pain, lacrimation disorder, parosmia, photophobia, taste loss, tinnitus.

Urogenital System: Albuminuria, balanitis, dysuria, hematuria, impotence, polyuria, urethral pain, uricaciduria, urinary frequency, urinary tract disorder, urination impaired, urine abnormality, vulvovaginal disorder.

Single dose Regimens

In clinical trials, patients were treated for uncomplicated gonorrhea using a single dose of RAXAR (grepafloxacin) 400 mg. There were no deaths or permanent disabilities in these studies.

Table 4 lists the adverse events which occurred with frequencies of 1% or greater. These events were thought by the investigators to be drug related in patients treated with RAXAR (grepafloxacin) Tablets in single-dose clinical trials.

Table 4
Drug-related Adverse Reactions in Grepafloxacin Treated Patients on a Single dose Dosing Regimen in Clinical Trials

Adverse Reaction
400 mg daily (n=487)
Vaginitis
5.0%
Nausea
3.3%
Dizziness
2.1%
Vomiting
2.1%
Headache
1.8%
Leukorrhea
1.2%
Abdominal pain
1.2%
Diarrhea
1.2%
Pruritus
1.2%
Taste perversion
1.2%

Additional drug-related events occurring in single dose clinical trials at a rate of less than 1 were:

    Body as a Whole: Asthenia, chest pain, chills, flu-like syndrome, infection, malaise.
    Cardiovascular System: Syncope, vasodilatation.
    Digestive System: Anorexia, constipation, increased appetite, tenesmus.
    Hemic and Lymphatic System: Lymphadenopathy.
    Nervous System: Hyperkinesia, insomnia, nervousness, somnolence.
    Respiratory System: Rhinitis.
    Skin and Appendages: Acne, rash, sweating.
    Urogenital System: Balanitis.

Observed During Clinical Practice

In addition to adverse reactions reported from clinical trials the following events have been identified during post-approval use of grepafloxacin formulations. Because they are reported voluntarily from a population of unknown size estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to grepafloxacin.

    Eye: Disturbances in vision.
    Non Site specific: Allergic reactions, including anaphylactoid reaction/anaphylactic shock, angioedema, laryngeal edema.