Home FDA labels 08dc4fad-78da-4e81-8cef-42627469a765 FDA label 08dc4fad-78da-4e81-8cef-42627469a765 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Acute Renal Failure Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir tablets for their level of renal function. Dosage reduction is recommended when administering famciclovir tablets to patients with renal impairment [see Dosage and Administration (2.3) , Use in Specific Populations (8.6) ] . Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of famciclovir tablets for their level of renal function. Reduce dosage in patients with renal impairment. ( 2.3 , 8.6 )
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adverse reactions 6 ADVERSE REACTIONS Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions (5) ] . The most common adverse events reported in at least 1 indication by > 10% of adult patients treated with famciclovir tablets are headache and nausea. The most common adverse events reported in at least 1 indication by > 10% of adult patients are headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Immunocompetent Patients The safety of famciclovir tablets has been evaluated in active- and placebo-controlled clinical studies involving 816 famciclovir tablet-treated patients with herpes zoster (famciclovir tablets, 250 mg three times daily to 750 mg three times daily); 163 famciclovir tablet-treated patients with recurrent genital herpes (famciclovir tablets, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with famciclovir tablets as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received famciclovir tablets (open-labeled and/or double-blind) for at least 10 months; and 447 famciclovir tablet-treated patients with herpes labialis (famciclovir tablets, 1500 mg once daily or 750 mg twice daily). Table 2 lists selected adverse events. Table 2. Selected Adverse Events (all grades and without regard to causality) Reported by ≥ 2% of Patients in Placebo-Controlled Famciclovir Tablet Trials Patients may have entered into more than one clinical trial. Incidence Events Herpes Zoster 7 days of treatment Recurrent Genital Herpes 1 day of treatment Genital Herpes- Suppression Daily treatment Herpes Labialis Famciclovir Tablets (n = 273) % Placebo (n = 146) % Famciclovir Tablets (n = 163) % Placebo (n = 166) % Famciclovir Tablets (n = 458) % Placebo (n = 63) % Famciclovir Tablets (n = 447) % Placebo (n = 254) % Nervous System Headache 22.7 17.8 13.5 5.4 39.3 42.9 8.5 6.7 Paresthesia 2.6 0.0 0.0 0.0 0.9 0.0 0.0 0.0 Migraine 0.7 0.7 0.6 0.6 3.1 0.0 0.2 0.0 Gastrointestinal Nausea 12.5 11.6 2.5 3.6 7.2 9.5 2.2 3.9 Diarrhea 7.7 4.8 4.9 1.2 9.0 9.5 1.6 0.8 Vomiting 4.8 3.4 1.2 0.6 3.1 1.6 0.7 0.0 Flatulence 1.5 0.7 0.6 0.0 4.8 1.6 0.2 0.0 Abdominal Pain 1.1 3.4 0.0 1.2 7.9 7.9 0.2 0.4 Body as a Whole Fatigue 4.4 3.4 0.6 0.0 4.8 3.2 1.6 0.4 Skin and Appendages Pruritus 3.7 2.7 0.0 0.6 2.2 0.0 0.0 0.0 Rash 0.4 0.7 0.0 0.0 3.3 1.6 0.0 0.0 Reproductive (Female) Dysmenorrhea 0.0 0.7 1.8 0.6 7.6 6.3 0.4 0.0 Table 3 lists selected laboratory abnormalities in genital herpes suppression trials. Table 3. Selected Laboratory Abnormalities in Genital Herpes Suppression Studies Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. NRH = Normal Range High. NRL = Normal Range Low. Parameter Famciclovir Tablets (n = 660) n values represent the minimum number of patients assessed for each laboratory parameter. % Placebo (n = 210) % Anemia (< 0.8 x NRL) 0.1 0.0 Leukopenia (< 0.75 x NRL) 1.3 0.9 Neutropenia (< 0.8 x NRL) 3.2 1.5 AST (SGOT) (> 2 x NRH) 2.3 1.2 ALT (SGPT) (> 2 x NRH) 3.2 1.5 Total Bilirubin (> 1.5 x NRH) 1.9 1.2 Serum Creatinine (> 1.5 x NRH) 0.2 0.3 Amylase (> 1.5 x NRH) 1.5 1.9 Lipase (> 1.5 x NRH) 4.9 4.7 HIV-Infected Patients In HIV-infected patients, the most frequently reported adverse events for famciclovir tablets (500 mg twice daily; n = 150) and acyclovir (400 mg, 5 times/day; n = 143), respectively, were headache (17% vs. 15%), nausea (11% vs. 13%), diarrhea (7% vs. 11%), vomiting (5% vs. 4%), fatigue (4% vs. 2%), and abdominal pain (3% vs. 6%). 6.2 Postmarketing Experience The adverse events listed below have been reported during postapproval use of famciclovir tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and Lymphatic System Disorders: Thrombocytopenia Hepatobiliary Disorders: Abnormal liver function tests, cholestatic jaundice Immune System Disorders: Anaphylactic shock, anaphylactic reaction. Nervous System Disorders: Dizziness, somnolence, seizure. Psychiatric Disorders: Confusion (including delirium, disorientation, and confusional state occurring predominantly in the elderly), hallucinations Skin and Subcutaneous Tissue Disorders: Urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema (e.g., face, eyelid, periorbital, and pharyngeal edema), hypersensitivity vasculitis Cardiac Disorders: Palpitations
adverse reactions table <table ID="_Refid_3b15d15b-1e1b-4dfb-992f-a23744593" width="100%"> <caption>Table 2. Selected Adverse Events (all grades and without regard to causality) Reported by ≥ 2% of Patients in Placebo-Controlled Famciclovir Tablet Trials<footnote ID="_Refid-8e8c091c-2879-4989-b583-a6b04b957">Patients may have entered into more than one clinical trial.</footnote> </caption> <col width="16%"/> <col width="12%"/> <col width="9%"/> <col width="12%"/> <col width="9%"/> <col width="12%"/> <col width="9%"/> <col width="12%"/> <col width="9%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"/> <td align="center" colspan="8" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Incidence</content> </paragraph> </td> </tr> <tr> <td rowspan="2" styleCode="Rrule Lrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Events</content> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Herpes Zoster</content> <footnote ID="_Ref443465040">7 days of treatment</footnote> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Recurrent</content> </paragraph> <paragraph> <content styleCode="bold">Genital Herpes </content> <footnote ID="_Refid-b920e8a2-5757-4fdc-a9db-5a3cec9dd">1 day of treatment</footnote> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Genital Herpes-</content> <content styleCode="bold">Suppression</content> <footnote ID="_Refid-de6413d8-fdd9-4c63-bd77-c3b69e1f2">Daily treatment</footnote> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="bottom"> <paragraph> <content styleCode="bold">Herpes Labialis</content> <footnoteRef IDREF="_Refid-b920e8a2-5757-4fdc-a9db-5a3cec9dd"/> </paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Famciclovir Tablets</content> <content styleCode="bold">(n = 273)</content> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n = 146)</content> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Famciclovir Tablets </content> </paragraph> <paragraph> <content styleCode="bold">(n = 163) </content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo </content> </paragraph> <paragraph> <content styleCode="bold">(n = 166) </content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Famciclovir Tablets</content> <content styleCode="bold">(n = 458)</content> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n = 63)</content> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Famciclovir Tablets </content> </paragraph> <paragraph> <content styleCode="bold">(n = 447)</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo </content> </paragraph> <paragraph> <content styleCode="bold">(n = 254)</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Nervous System</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Headache </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>22.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>17.8</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>13.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>5.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>39.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>42.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>8.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>6.7</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Paresthesia </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Migraine </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Gastrointestinal</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Nausea </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>12.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>11.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>7.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>9.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Diarrhea</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>7.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.8</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>9.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>9.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.8</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Vomiting </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.8</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Flatulence </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.8</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Abdominal Pain </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>7.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>7.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.4</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Body as a Whole</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Fatigue </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.8</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.4</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Skin and Appendages</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Pruritus </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Rash </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Reproductive (Female)</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Dysmenorrhea</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>1.8</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>7.6</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>6.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>0.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table ID="_Refid_63ebdc04-7df7-44af-8bc5-c54771d1d" width="100%"> <caption>Table 3. Selected Laboratory Abnormalities in Genital Herpes Suppression Studies<footnote ID="_Refid-fd82c143-04dd-454d-a947-b42a25669">Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. </footnote> </caption> <col width="56%"/> <col width="24%"/> <col width="20%"/> <tfoot> <tr> <td align="left" colspan="12" styleCode="Botrule" valign="top">NRH = Normal Range High. NRL = Normal Range Low.</td> </tr> </tfoot> <tbody> <tr> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Parameter</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Famciclovir Tablets </content> </paragraph> <paragraph> <content styleCode="bold">(n = 660)</content> <footnote ID="_Refid-51fd40ff-6a5a-4e63-ab43-12ab12dc1">n values represent the minimum number of patients assessed for each laboratory parameter.</footnote> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo </content> </paragraph> <paragraph> <content styleCode="bold">(n = 210)</content> <footnoteRef IDREF="_Refid-51fd40ff-6a5a-4e63-ab43-12ab12dc1"/> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Anemia (< 0.8 x NRL) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Leukopenia (< 0.75 x NRL) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Neutropenia (< 0.8 x NRL) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.5</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>AST (SGOT) (> 2 x NRH) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>2.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>ALT (SGPT) (> 2 x NRH) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.5</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Total Bilirubin (> 1.5 x NRH) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.9 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Serum Creatinine (> 1.5 x NRH) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Amylase (> 1.5 x NRH) </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.5 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Lipase (> 1.5 x NRH) </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>4.9 </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>4.7</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.