Home FDA labels 4bb69d4e-059a-03aa-e054-00144ff88e88 FDA label 4bb69d4e-059a-03aa-e054-00144ff88e88 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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SPL set ID 3ed5acba-1d00-4144-a20a-78ccda09eea6
SPL ID 4bb69d4e-059a-03aa-e054-00144ff88e88
Version 3
Effective date 2017-03-27
Source export date 2026-10-12
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
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warnings and cautions 5.8 Development of Drug Resistant Bacteria Prescribing BIAXIN in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
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adverse reactions table <table ID="Table_5" border="1" frame="box" rules="all" width="100%"> <caption>Table 5. Percentage of Patients <sup>a</sup> Exceeding Extreme Laboratory Values in Patients Receiving Prophylaxis Against M. avium Complex </caption> <col/> <col/> <col/> <col/> <tbody> <tr> <td colspan="2" styleCode="Toprule Botrule Lrule"> </td> <td align="center" styleCode="Toprule Botrule Lrule"> <content styleCode="bold">BIAXIN 500 mg </content> <content styleCode="bold">twice a day</content> </td> <td align="center" styleCode="Toprule Botrule Lrule Rrule"> <content styleCode="bold">Placebo</content> </td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule">WBC Count </td> <td align="center" styleCode="Toprule Botrule Lrule"><1 x 10 <sup>9</sup>/L </td> <td align="center" styleCode="Toprule Botrule Lrule">2/103 (4%) </td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">0/95 </td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule">SGOT </td> <td align="center" styleCode="Toprule Botrule Lrule">>5 x ULN <sup>b</sup> </td> <td align="center" styleCode="Toprule Botrule Lrule">7/196 (4%)</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">5/208 (2%) </td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule">SGPT</td> <td align="center" styleCode="Toprule Botrule Lrule">>5 x ULN <sup>b</sup> </td> <td align="center" styleCode="Toprule Botrule Lrule">6/217 (3%)</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">4/232 (2%)</td> </tr> <tr> <td colspan="4" align="left" styleCode="Toprule Botrule Lrule" valign="top"> <paragraph ID="p97771291436381230">a Includes only patients with baseline values within the normal range or borderline high (hematology variables) and within normal range or borderline low (chemistry variables)</paragraph> <paragraph ID="p99861291436381230">b ULN= Upper Limit of Normal</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table ID="Table_6" border="1" frame="box" rules="all" width="100%"> <caption>Table 6. Selected Treatment-Related <sup>a</sup> Adverse Reaction Incidence Rates (%) in Immunocompromised Adult Patients During the First 12 Weeks of Therapy with 500 mg Twice a Day BIAXIN Dose </caption> <col/> <col/> <col/> <col/> <tbody> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule"> <content styleCode="bold">Adverse Reaction</content> </td> <td align="center" styleCode="Toprule Botrule"> <content styleCode="bold">Trial 1</content> <content styleCode="bold">(n=53)</content> </td> <td align="center" styleCode="Toprule Botrule Lrule"> <content styleCode="bold">Trial 2</content> <content styleCode="bold">(n=255)</content> </td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule"> <content styleCode="bold">Combined</content> <content styleCode="bold">(n=308)</content> </td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Abdominal Pain</td> <td align="center" styleCode="Toprule Botrule">8</td> <td align="center" styleCode="Toprule Botrule Lrule">2</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">3</td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Diarrhea </td> <td align="center" styleCode="Toprule Botrule">9</td> <td align="center" styleCode="Toprule Botrule Lrule">2</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">3</td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Flatulence </td> <td align="center">8</td> <td align="center" styleCode="Toprule Botrule Lrule">0</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">1</td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Headache </td> <td align="center" styleCode="Toprule Botrule">8</td> <td align="center" styleCode="Toprule Botrule Lrule">0</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">2</td> </tr> <tr> <td align="center" styleCode="BOTTTOM Lrule Rrule">Nausea </td> <td align="center" styleCode="Toprule Botrule">28</td> <td align="center" styleCode="Toprule Botrule Lrule">9</td> <td align="center" styleCode=" BOTTTOM Lrule Rrule">12</td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Rash </td> <td align="center" styleCode="Toprule Botrule">9</td> <td align="center" styleCode="Toprule Botrule Lrule">2</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">3</td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Taste Perversion </td> <td align="center" styleCode="Toprule Botrule">19</td> <td align="center" styleCode="Toprule Botrule Lrule">0</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">4</td> </tr> <tr> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">Vomiting</td> <td align="center" styleCode="Toprule Botrule">25</td> <td align="center" styleCode="Toprule Botrule Lrule">4</td> <td align="center" styleCode="Toprule BOTTTOM Lrule Rrule">8</td> </tr> <tr> <td colspan="4" styleCode="Toprule BOTTTOM Lrule Rrule">a Includes those events possibly or probably related to study drug and excludes concurrent conditions</td> </tr> </tbody> </table>
adverse reactions table <table ID="Table_7" border="1" frame="box" rules="all" width="100%"> <caption>Table 7. Adverse Reactions with an Incidence of 3% or Greater </caption> <col width="25*"/> <col width="24*"/> <col width="24*"/> <col width="24*"/> <tbody> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule"> <content styleCode="bold">Adverse Reaction </content> </td> <td align="center" styleCode="Toprule Botrule"> <content styleCode="bold">BIAXIN + Omeprazole</content> <content styleCode="bold">(n=346)</content> <content styleCode="bold">% of Patients</content> </td> <td align="center" styleCode="Toprule Botrule Lrule"> <content styleCode="bold">Omeprazole </content> <content styleCode="bold"> (n=355) </content> <content styleCode="bold">% of Patients </content> </td> <td align="center" styleCode="Toprule Botrule Lrule Rrule"> <content styleCode="bold">BIAXIN</content> <content styleCode="bold">(n=166)</content> <content styleCode="bold">% of Patients <sup>a</sup> </content> </td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule">Taste Perversion </td> <td align="center" styleCode="Toprule Botrule">15</td> <td align="center" styleCode="Toprule Botrule Lrule">1</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">16</td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule">Nausea </td> <td align="center" styleCode="Toprule Botrule">5</td> <td align="center" styleCode="Toprule Botrule Lrule">1</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">3</td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule">Headache </td> <td align="center" styleCode="Toprule Botrule">5</td> <td align="center" styleCode="Toprule Botrule Lrule">6</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">9</td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule">Diarrhea </td> <td align="center" styleCode="Toprule Botrule">4</td> <td align="center" styleCode="Toprule Botrule Lrule">3</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">7</td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule">Vomiting </td> <td align="center" styleCode="Toprule Botrule">4</td> <td align="center" styleCode="Toprule Botrule Lrule"><1</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">1</td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule">Abdominal Pain </td> <td align="center" styleCode="Toprule Botrule">3</td> <td align="center" styleCode="Toprule Botrule Lrule">2</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">1</td> </tr> <tr> <td align="center" styleCode="Toprule Botrule Lrule Rrule"> Infection</td> <td align="center" styleCode="Toprule Botrule">3</td> <td align="center" styleCode="Toprule Botrule Lrule">4</td> <td align="center" styleCode="Toprule Botrule Lrule Rrule">2</td> </tr> <tr valign="top"> <td colspan="4" align="left" styleCode="Toprule Botrule Lrule Rrule">a Only two of four studies</td> </tr> </tbody> </table>
adverse reactions table <table ID="Table_4" border="0" frame="border" rules="none" width="100%"> <caption>Table 4. Incidence Rates (%) of Selected Adverse Reactions <sup>a</sup> in Immunocompromised Adult Patients Receiving Prophylaxis Against M. avium Complex </caption> <col/> <col/> <col/> <tbody> <tr> <td align="left" styleCode="Rrule Lrule Toprule"> <content styleCode="bold">Body System <sup>b</sup> </content> </td> <td rowspan="2" align="center" styleCode="Botrule Rrule Lrule Toprule"> <content styleCode="bold">BIAXIN</content> <content styleCode="bold">(n=339)</content> <content styleCode="bold">%</content> </td> <td rowspan="2" align="center" styleCode="Rrule Botrule Rrule Toprule"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n=339)</content> <content styleCode="bold">%</content> </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule"> <content styleCode="bold">Adverse Reaction</content> </td> </tr> <tr> <td styleCode="Lrule Rrule Botrule"> <content styleCode="bold">Body as a Whole</content> </td> <td styleCode="Rrule Botrule Lrule"> </td> <td styleCode="Botrule Rrule"> </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Abdominal pain </td> <td align="center" styleCode="Rrule Botrule Rrule">5%</td> <td align="center" styleCode="Rrule Botrule Rrule">4% </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Headache </td> <td align="center" styleCode="Rrule Botrule Rrule">3%</td> <td align="center" styleCode="Rrule Botrule Rrule">1%</td> </tr> <tr> <td styleCode="Lrule Rrule Botrule"> <content styleCode="bold">Digestive </content> </td> <td align="center" styleCode="Rrule Botrule Lrule"> </td> <td styleCode="Botrule Rrule"> </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Diarrhea </td> <td align="center" styleCode="Rrule Botrule Rrule">8%</td> <td align="center" styleCode="Rrule Botrule Rrule">4% </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Dyspepsia </td> <td align="center" styleCode="Rrule Botrule Rrule">4%</td> <td align="center" styleCode="Rrule Botrule Rrule">3%</td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Flatulence </td> <td align="center" styleCode="Rrule Botrule Rrule">2%</td> <td align="center" styleCode="Rrule Botrule Rrule">1%</td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Nausea </td> <td align="center" styleCode="Rrule Botrule Rrule">11%</td> <td align="center" styleCode="Rrule Botrule Rrule">7%</td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Vomiting </td> <td align="center" styleCode="Rrule Botrule Rrule">6%</td> <td align="center" styleCode="Rrule Botrule Rrule">3%</td> </tr> <tr> <td styleCode="Lrule Rrule Botrule"> <content styleCode="bold">Skin & Appendages</content> </td> <td align="center" styleCode="Rrule Botrule Rrule"> </td> <td styleCode="Botrule Rrule"> </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule">Rash </td> <td align="center" styleCode="Rrule Botrule Rrule">3%</td> <td align="center" styleCode="Rrule Botrule Rrule">4%</td> </tr> <tr> <td styleCode="Lrule Rrule Botrule"> <content styleCode="bold">Special Senses</content> </td> <td align="center" styleCode="Rrule Botrule Rrule"> </td> <td styleCode="Botrule Rrule"> </td> </tr> <tr> <td align="center" styleCode="Lrule Rrule Botrule" valign="middle">Taste Perversion </td> <td align="center" styleCode="Rrule Botrule Rrule">8% <sup>c</sup> </td> <td align="center" styleCode="Rrule Botrule Rrule">0.3%</td> </tr> <tr valign="top"> <td colspan="3" align="left" styleCode="Lrule Rrule Botrule"> <paragraph ID="p92391291436378037">a Includes those events possibly or probably related to study drug and excludes concurrent conditions </paragraph> <paragraph ID="p92421291436378037">b 2% or greater Adverse Reaction Incidence Rates for either treatment group</paragraph> <paragraph ID="p92451291436378037">c Significant higher incidence compared to the placebo-treated group</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.