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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 for their level of renal function. Dosage reduction is recommended when administering famciclovir 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 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 are headache and nausea. The most common adverse events reported in at least one indication by >10% of adult patients are headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com ; 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 has been evaluated in active- and placebo-controlled clinical studies involving 816 famciclovir-treated patients with herpes zoster (famciclovir, 250 mg three times daily to 750 mg three times daily); 163 famciclovir-treated patients with recurrent genital herpes (famciclovir, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with famciclovir as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received famciclovir (open-labeled and/or double-blind) for at least 10 months; and 447 famciclovir-treated patients with herpes labialis (famciclovir, 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 Famcicovir Trials Patients may have entered into more than one clinical trial. Incidence Herpes Zoster 7 days of treatment Recurrent Genital Herpes 1 day of treatment Genital Herpes- Supression daily treatment Herpes Labialis Event Famciclovir Placebo Famciclovir Placebo Famciclovir Placebo Famciclovir Placebo (n = 273) (n = 146) (n = 163) (n = 166) (n = 458) (n = 63) (n = 447) (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 0.9 0 0 0 Migraine 0.7 0.7 0.6 0.6 3.1 0 0.2 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 Flatulence 1.5 0.7 0.6 0 4.8 1.6 0.2 0 Abdominal Pain 1.1 3.4 0 1.2 7.9 7.9 0.2 0.4 Body as a Whole Fatigue 4.4 3.4 0.6 0 4.8 3.2 1.6 0.4 Skin and Appendages Pruritus 3.7 2.7 0 0.6 2.2 0 0 0 Rash 0.4 0.7 0 0 3.3 1.6 0 0 Reproductive (Female) Dysmenorrhea 0 0.7 1.8 0.6 7.6 6.3 0.4 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. Parameter Famciclovir (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 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 NRH = Normal Range High. NRL = Normal Range Low. HIV-infected patients: In HIV-infected patients, the most frequently reported adverse events for famciclovir (500 mg twice daily; n = 150) and acyclovir (400 mg, 5x/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 post-approval use of famciclovir. 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 Nervous system disorders : Dizziness, somnolence 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., grace, eyelid, periorbital, and pharyngeal edema.), leukocytoclastic vasculitis. Cardiac disorders : Palpitations
adverse reactions table <table ID="id_f93f7dd7-8b16-4e8c-829e-0f085f91a90e" border="single" width="525"> <caption ID="id_ec0ee802-ee9e-410c-a024-3700e9734782">Table 2: Selected Adverse Events (All Grades and Without Regard to Causality) Reported by ≥ 2% of Patients in Placebo-Controlled Famcicovir Trials <footnote ID="id-73275b73-10c2-47bd-9c9b-3b9f9750ed6e">Patients may have entered into more than one clinical trial.</footnote> </caption> <col width="13.5%"/> <col width="12.4%"/> <col width="8.8%"/> <col width="12.4%"/> <col width="8.8%"/> <col width="12.6%"/> <col width="9.1%"/> <col width="13.3%"/> <col width="9.1%"/> <tbody> <tr ID="id_ce998490-0de1-41ea-85eb-6206bd071cba"> <td align="center" colspan="9" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Incidence</content> </td> </tr> <tr ID="id_d4605c52-a23e-45dd-8551-218465bac570"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top"/> <td align="center" colspan="2" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Herpes Zoster <footnote ID="id-6e62cbeb-14ba-44eb-8125-e22b5d479868">7 days of treatment</footnote> </content> </td> <td align="center" colspan="2" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Recurrent Genital Herpes <footnote ID="id-fb1fa213-e500-4cf6-8074-8dd5de657822">1 day of treatment</footnote> </content> </td> <td align="center" colspan="2" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Genital Herpes- Supression <footnote ID="id-312fc3ea-fb2b-4a8c-98cd-840829a90b65">daily treatment</footnote> </content> </td> <td align="center" colspan="2" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Herpes Labialis <footnoteRef IDREF="id-fb1fa213-e500-4cf6-8074-8dd5de657822"/> </content> </td> </tr> <tr ID="id_acf7fab1-cc2e-4862-9839-fca2eb192b0f"> <td align="left" rowspan="3" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Event</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Famciclovir</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Placebo</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Famciclovir</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Placebo</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Famciclovir</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Placebo</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Famciclovir</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Placebo</content> </td> </tr> <tr ID="id_31acea8b-6cff-4c7d-ad85-244b563324d4"> <td align="center" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">(n = 273)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 146)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 163)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 166)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 458)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 63)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 447)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">(n = 254)</content> </td> </tr> <tr ID="id_d3fbe4ea-70cf-44a0-ac07-cb6ed4baf961"> <td align="center" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">%</content> </td> </tr> <tr ID="id_efffc7a6-732f-45ba-95a8-15df55b9d6d6"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Nervous System</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> </tr> <tr ID="id_1d2e5c6f-cc5f-4b1e-8e91-a57536752b93"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Headache </td> <td align="center" styleCode="Botrule Rrule" valign="top">22.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">17.8</td> <td align="center" styleCode="Botrule Rrule" valign="top">13.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">5.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">39.3</td> <td align="center" styleCode="Botrule Rrule" valign="top">42.9</td> <td align="center" styleCode="Botrule Rrule" valign="top">8.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">6.7</td> </tr> <tr ID="id_21a6c00c-9b97-4564-a043-33cf830dea79"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Paresthesia </td> <td align="center" styleCode="Botrule Rrule" valign="top">2.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.9</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_0feb5975-99d5-431e-80ff-c48c4ce1b167"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Migraine </td> <td align="center" styleCode="Botrule Rrule" valign="top">0.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.1</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_e56e4e97-8947-428e-8054-70cb63d49337"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Gastrointestinal</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> </tr> <tr ID="id_d40d8889-13b3-4f75-ae33-a8feea1408e8"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Nausea </td> <td align="center" styleCode="Botrule Rrule" valign="top">12.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">11.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">2.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">7.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">9.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">2.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.9</td> </tr> <tr ID="id_823a2e4d-3a23-4f04-90c8-65af800ad6e5"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Diarrhea </td> <td align="center" styleCode="Botrule Rrule" valign="top">7.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">4.8</td> <td align="center" styleCode="Botrule Rrule" valign="top">4.9</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">9.0</td> <td align="center" styleCode="Botrule Rrule" valign="top">9.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.8</td> </tr> <tr ID="id_e4f99d6a-282c-4512-a896-e993701689fa"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Vomiting </td> <td align="center" styleCode="Botrule Rrule" valign="top">4.8</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.1</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_6d0fc348-55d0-4c79-b243-57d5fc10d77f"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Flatulence </td> <td align="center" styleCode="Botrule Rrule" valign="top">1.5</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">4.8</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_0fdcb056-b1c6-4ea1-97e6-4640dbf21ffb"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Abdominal Pain </td> <td align="center" styleCode="Botrule Rrule" valign="top">1.1</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">7.9</td> <td align="center" styleCode="Botrule Rrule" valign="top">7.9</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.4</td> </tr> <tr ID="id_f2e59740-1aaa-4abb-891a-8da85f107022"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Body as a Whole</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> </tr> <tr ID="id_98f8e9bf-d2ef-44c1-9513-eb5555c8828c"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Fatigue </td> <td align="center" styleCode="Botrule Rrule" valign="top">4.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">4.8</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.4</td> </tr> <tr ID="id_961b95b4-a314-49cc-aa33-dadb18d8a342"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Skin and Appendages</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> </tr> <tr ID="id_767327e2-d1ec-43d1-a198-42ec1ae77fa7"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Pruritus </td> <td align="center" styleCode="Botrule Rrule" valign="top">3.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">2.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">2.2</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_14a12d56-e57e-489c-9984-8fca07a24699"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Rash </td> <td align="center" styleCode="Botrule Rrule" valign="top">0.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">0.7</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.3</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.6</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> <tr ID="id_a110a735-6836-411e-b76d-28b44650cd34"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top"> <content styleCode="bold">Reproductive (Female)</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> <td align="center" styleCode="Botrule Rrule" valign="top"/> </tr> <tr ID="id_c48df2fc-ab79-45f7-92a5-c3c8bbac4411"> <td align="left" styleCode="Botrule Lrule Rrule" valign="top">Dysmenorrhea </td> <td align="center" styleCode="Rrule" valign="top">0</td> <td align="center" styleCode="Rrule" valign="top">0.7</td> <td align="center" styleCode="Rrule" valign="top">1.8</td> <td align="center" styleCode="Rrule" valign="top">0.6</td> <td align="center" styleCode="Rrule" valign="top">7.6</td> <td align="center" styleCode="Rrule" valign="top">6.3</td> <td align="center" styleCode="Rrule" valign="top">0.4</td> <td align="center" styleCode="Botrule Rrule" valign="top">0</td> </tr> </tbody> </table>
adverse reactions table <table ID="id_e818e094-9594-44fd-8e8f-2fbaaefa006d" border="single" width="344"> <caption ID="id_2ec05c5f-b997-42ca-a39c-02097624bf81">Table 3: Selected Laboratory Abnormalities in Genital Herpes Suppression Studies <footnote ID="id-8b1e97b6-0017-4218-85da-77a8260cad46">Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. </footnote> </caption> <col width="54.7%"/> <col width="22.7%"/> <col width="22.7%"/> <tbody> <tr ID="id_11d61a6a-4d2f-49a0-81e1-6e1a13eec050"> <td align="left" styleCode="Botrule Lrule Toprule" valign="top"> <content styleCode="bold">Parameter</content> </td> <td align="center" styleCode="Botrule" valign="middle"> <content styleCode="bold">Famciclovir (n = 660)</content> <footnote ID="id-f58b71c3-c5a7-4a0b-9844-94936cb25508">n values represent the minimum number of patients assessed for each laboratory parameter. </footnote> <content styleCode="bold"> % </content> </td> <td align="center" styleCode="Botrule Rrule" valign="middle"> <content styleCode="bold">Placebo (n = 210) <footnoteRef IDREF="id-f58b71c3-c5a7-4a0b-9844-94936cb25508"/> </content> <content styleCode="bold"> % </content> </td> </tr> <tr ID="id_e4e8b385-5c1d-490c-8b2e-ac923b470a16"> <td align="left" styleCode="Botrule Lrule" valign="middle">Anemia (< 0.8 x NRL) </td> <td align="center" styleCode="Botrule" valign="middle">0.1 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">0</td> </tr> <tr ID="id_8784d933-a5cb-4a16-8f85-d0dea2254d72"> <td align="left" styleCode="Botrule Lrule" valign="middle">Leukopenia (< 0.75 x NRL) </td> <td align="center" styleCode="Botrule" valign="middle">1.3 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">0.9 </td> </tr> <tr ID="id_c20ff5bd-11c4-4d22-8d00-b8b37652b484"> <td align="left" styleCode="Botrule Lrule" valign="middle">Neutropenia (< 0.8 x NRL) </td> <td align="center" styleCode="Botrule" valign="middle">3.2 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">1.5 </td> </tr> <tr ID="id_f8fdc01e-3006-4a0e-a23e-4794982ad04b"> <td align="left" styleCode="Botrule Lrule" valign="middle">AST (SGOT) (> 2 x NRH) </td> <td align="center" styleCode="Botrule" valign="middle">2.3 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">1.2 </td> </tr> <tr ID="id_b5142868-2f53-42ba-88f7-6f27d9cd6081"> <td align="left" styleCode="Botrule Lrule" valign="middle">ALT (SGPT) (> 2 x NRH) </td> <td align="center" styleCode="Botrule" valign="middle">3.2 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">1.5 </td> </tr> <tr ID="id_7a2d587e-6c0b-410b-9d80-527ed193d900"> <td align="left" styleCode="Botrule Lrule" valign="middle">Total Bilirubin (> 1.5 x NRH) </td> <td align="center" styleCode="Botrule" valign="middle">1.9 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">1.2 </td> </tr> <tr ID="id_c0df6013-b933-4cd3-af93-9e5e95f1181f"> <td align="left" styleCode="Botrule Lrule" valign="middle">Serum Creatinine (> 1.5 x NRH) </td> <td align="center" styleCode="Botrule" valign="middle">0.2 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">0.3 </td> </tr> <tr ID="id_bd1ec768-a10b-4aea-9639-ce49a1d33316"> <td align="left" styleCode="Botrule Lrule" valign="middle">Amylase (> 1.5 x NRH) </td> <td align="center" styleCode="Botrule" valign="middle">1.5 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">1.9 </td> </tr> <tr ID="id_5a69145b-f2a8-4da1-af2b-6baad4de6b6c"> <td align="left" styleCode="Botrule Lrule" valign="middle">Lipase (> 1.5 x NRH) </td> <td align="center" styleCode="Botrule" valign="middle">4.9 </td> <td align="center" styleCode="Botrule Rrule" valign="middle">4.7 </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.