Home FDA labels c44712eb-0e9d-4f40-b932-e27d2a100c29 FDA label c44712eb-0e9d-4f40-b932-e27d2a100c29 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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Effective date 2020-11-05
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warnings WARNINGS The potential for a delayed hypersensitivity reaction to fluorouracil exists. Patch testing to prove hypersensitivity may be inconclusive. Patients should discontinue therapy with fluorouracil cream 0.5% if symptoms of DPD enzyme deficiency develop. Rarely, unexpected, systemic toxicity (e.g. stomatitis, diarrhea, neutropenia, and neurotoxicity) associated with parenteral administration of fluorouracil has been attributed to deficiency of dihydropyrimidine dehydrogenase "DPD" activity. One case of life threatening systemic toxicity has been reported with the topical use of 5% fluorouracil in a patient with a complete absence of DPD enzyme activity. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil. Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
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adverse reactions ADVERSE REACTIONS The following were adverse events considered to be drug-related and occurring with a frequency of ≥1% with fluorouracil cream 0.5%: application site reaction (94.6%), and eye irritation (5.4%). The signs and symptoms of facial irritation (application site reaction) are presented below. Summary of Facial Irritation Signs and Symptoms - Pooled Phase 3 Studies Clinical Sign or Symptom Active One Week N=85 Active Two Week N=87 Active Four Week N=85 ALL Active Treatments N=257 Vehicle Treatments N=127 n (%) n (%) n (%) n (%) n (%) Erythema 76 (89.4) 82 (94.3) 82 (96.5) 240 (93.4) 76 (59.8) Dryness 59 (69.4) 76 (87.4) 79 (92.9) 214 (83.3) 60 (47.2) Burning 51 (60.0) 70 (80.5) 71 (83.5) 192 (74.7) 28 (22.0) Erosion 21 (24.7) 38 (43.7) 54 (63.5) 113 (44.0) 17 (13.4) Pain 26 (30.6) 34 (39.1) 52 (61.2) 112 (43.6) 7 (5.5) Edema 12 (14.1) 28 (32.2) 51 (60.0) 91 (35.4) 6 (4.7) During clinical trials, irritation generally began on day 4 and persisted for the remainder of treatment. Severity of facial irritation at the last treatment visit was slightly below baseline for the vehicle group, mild to moderate for the 1 week active treatment group, and moderate for the 2 and 4 week active treatment groups. Mean severity declined rapidly for each active group after completion of treatment and was below baseline for each group at the week 2 post-treatment follow-up visit. Thirty-one patients (12% of those treated with fluorouracil cream 0.5% in the Phase 3 clinical studies) discontinued study treatment early due to facial irritation. Except for three patients, discontinuation of treatment occurred on or after day 11 of treatment. Eye irritation adverse events, described as mild to moderate in intensity, were characterized as burning, watering, sensitivity, stinging and itching. These adverse events occurred across all treatment arms in one of the two Phase 3 studies. Summary of All Adverse Events Reported in ≥ 1% of Patients in the Combined Active Treatment and Vehicle Groups - Pooled Phase 3 Studies 9721 and 9722 Combined Adverse Event Active One Week N= 85 Active Two Week N= 87 Active Four Week N= 85 ALL Active Treatments N=257 Vehicle Treatments N=127 n (%) n (%) n (%) n (%) n (%) BODY AS A WHOLE 7 (8.2) 6 (6.9) 12 (14.1) 25 (9.7) 15 (11.8) Headache 3 (3.5) 2 (2.3) 3 (3.5) 8 (3.1) 3 (2.4) Common Cold 4 (4.7) 0 2 (2.4) 6 (2.3) 3 (2.4) Allergy 0 2 (2.3) 1 (1.2) 3 (1.2) 2 (1.6) Infection Upper 0 0 0 0 2 (1.6) Respiratory MUSCULOSKELETAL 1 (1.2) 1 (1.1) 1 (1.2) 3 (1.2) 5 (3.9) Muscle Soreness 0 0 0 0 2 (1.6) RESPIRATORY 5 (5.9) 0 1 (1.2) 6 (2.3) 6 (4.7) Sinusitis 4 (4.7) 0 0 4 (1.6) 2 (1.6) SKIN & APPENDAGES 78 (91.8) 83 (95.4) 82 (96.5) 243 (94.6) 85 (66.9) Application Site 78 (91.8) 83 (95.4) 82 (96.5) 243 (94.6) 83 (65.4) Reaction Irritation Skin 1 (1.2) 0 2 (2.4) 3 (1.2) 0 SPECIAL SENSES 6 (7.1) 4 (4.6) 6 (7.1) 16 (6.2) 6 (4.7) Eye Irritation 5 (5.9) 3 (3.4) 6 (7.1) 14 (5.4) 3 (2.4) Adverse Experiences Reported by Body System: In the Phase 3 studies, no serious adverse event was considered related to study drug. A total of five patients, three in the active treatment groups and two in the vehicle group, experienced at least one serious adverse event. Three patients died as a result of adverse event(s) considered unrelated to study drug (stomach cancer, myocardial infarction and cardiac failure). Post-treatment clinical laboratory tests other than pregnancy tests were not performed during the Phase 3 clinical studies. Clinical laboratory tests were performed during conduct of a Phase 2 study of 104 patients and 21 patients in a Phase 1 study. No abnormal serum chemistry, hematology, or urinalysis results in these studies were considered clinically significant.
adverse reactions table <table ID="_RefID0EPPAC" width="80%"><caption>Summary of Facial Irritation Signs and Symptoms - Pooled Phase 3 Studies</caption><col width="12%"/><col width="5%"/><col width="8%"/><col width="5%"/><col width="8%"/><col width="5%"/><col width="8%"/><col width="6%"/><col width="8%"/><col width="6%"/><col width="8%"/><thead><tr><th align="left" styleCode="Lrule Toprule " valign="top"><content styleCode="bold">Clinical Sign or Symptom</content></th><th align="center" colspan="2" styleCode="Toprule " valign="top"><content styleCode="bold">Active One Week</content> <content styleCode="bold">N=85</content></th><th align="center" colspan="2" styleCode="Toprule " valign="top"><content styleCode="bold">Active Two Week</content> <content styleCode="bold">N=87</content></th><th align="center" colspan="2" styleCode="Toprule " valign="top"><content styleCode="bold">Active Four Week</content> <content styleCode="bold">N=85</content></th><th align="center" colspan="2" styleCode="Toprule " valign="top"><content styleCode="bold">ALL Active Treatments</content> <content styleCode="bold">N=257</content></th><th align="center" colspan="2" styleCode="Rrule Toprule " valign="top"><content styleCode="bold">Vehicle Treatments</content> <content styleCode="bold">N=127</content></th></tr><tr><th align="left" styleCode="Lrule Botrule " valign="top"/><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">n</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">n</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">n</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">n</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="center" styleCode="Botrule " valign="top"><content styleCode="bold">n</content></th><th align="center" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">(%)</content></th></tr></thead><tbody><tr><td styleCode="Lrule Toprule " valign="top"><paragraph>Erythema </paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>76</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>(89.4)</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>82</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>(94.3)</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>82</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>(96.5)</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>240</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>(93.4)</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>76</paragraph></td><td align="center" styleCode="Rrule Toprule " valign="top"><paragraph>(59.8)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph> Dryness</paragraph></td><td align="center" valign="top"><paragraph>59</paragraph></td><td align="center" valign="top"><paragraph>(69.4)</paragraph></td><td align="center" valign="top"><paragraph>76</paragraph></td><td align="center" valign="top"><paragraph>(87.4)</paragraph></td><td align="center" valign="top"><paragraph>79</paragraph></td><td align="center" valign="top"><paragraph>(92.9)</paragraph></td><td align="center" valign="top"><paragraph>214</paragraph></td><td align="center" valign="top"><paragraph>(83.3)</paragraph></td><td align="center" valign="top"><paragraph>60</paragraph></td><td align="center" styleCode="Rrule " valign="top"><paragraph>(47.2)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph> Burning </paragraph></td><td align="center" valign="top"><paragraph>51</paragraph></td><td align="center" valign="top"><paragraph>(60.0)</paragraph></td><td align="center" valign="top"><paragraph>70</paragraph></td><td align="center" valign="top"><paragraph>(80.5)</paragraph></td><td align="center" valign="top"><paragraph>71</paragraph></td><td align="center" valign="top"><paragraph>(83.5)</paragraph></td><td align="center" valign="top"><paragraph>192</paragraph></td><td align="center" valign="top"><paragraph>(74.7)</paragraph></td><td align="center" valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule " valign="top"><paragraph>(22.0)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph> Erosion </paragraph></td><td align="center" valign="top"><paragraph>21</paragraph></td><td align="center" valign="top"><paragraph>(24.7)</paragraph></td><td align="center" valign="top"><paragraph>38</paragraph></td><td align="center" valign="top"><paragraph>(43.7)</paragraph></td><td align="center" valign="top"><paragraph>54</paragraph></td><td align="center" valign="top"><paragraph>(63.5)</paragraph></td><td align="center" valign="top"><paragraph>113</paragraph></td><td align="center" valign="top"><paragraph>(44.0)</paragraph></td><td align="center" valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule " valign="top"><paragraph>(13.4)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Pain </paragraph></td><td align="center" valign="top"><paragraph>26</paragraph></td><td align="center" valign="top"><paragraph>(30.6)</paragraph></td><td align="center" valign="top"><paragraph>34</paragraph></td><td align="center" valign="top"><paragraph>(39.1)</paragraph></td><td align="center" valign="top"><paragraph>52</paragraph></td><td align="center" valign="top"><paragraph>(61.2)</paragraph></td><td align="center" valign="top"><paragraph>112</paragraph></td><td align="center" valign="top"><paragraph>(43.6)</paragraph></td><td align="center" valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule " valign="top"><paragraph>(5.5)</paragraph></td></tr><tr><td styleCode="Botrule Lrule " valign="top"><paragraph> Edema </paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>(14.1)</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>(32.2)</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>51</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>(60.0)</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>91</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>(35.4)</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>(4.7)</paragraph></td></tr></tbody></table>
adverse reactions table <table ID="_RefID0EDFAE" width="103.08%"><caption>Summary of All Adverse Events Reported in ≥ 1% of Patients in the Combined Active Treatment and Vehicle Groups - Pooled Phase 3 Studies </caption><col width="24%"/><col width="4%"/><col width="8%"/><col width="4%"/><col width="9%"/><col width="4%"/><col width="12%"/><col width="7%"/><col width="8%"/><col width="4%"/><col width="14%"/><col width="0%"/><thead><tr><th align="left" colspan="12" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">9721 and 9722 Combined</content></th></tr><tr><th align="left" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">Adverse Event</content></th><th align="center" colspan="2" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">Active One Week</content> <content styleCode="bold">N= 85</content></th><th align="center" colspan="2" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">Active Two Week</content> <content styleCode="bold">N= 87</content></th><th align="center" colspan="2" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">Active Four Week</content> <content styleCode="bold">N= 85</content></th><th align="center" colspan="2" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">ALL Active Treatments</content> <content styleCode="bold">N=257</content></th><th align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><content styleCode="bold">Vehicle Treatments</content> <content styleCode="bold">N=127</content></th></tr><tr><th align="left" styleCode="Lrule Botrule " valign="top"/><th align="left" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">n</content></th><th align="left" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="left" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">n</content></th><th align="left" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="left" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">n</content></th><th align="left" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="left" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">n</content></th><th align="left" styleCode="Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="left" styleCode="Lrule Botrule " valign="top"><content styleCode="bold">n</content></th><th align="left" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">(%)</content></th></tr></thead><tbody><tr><td styleCode="Lrule Toprule " valign="top"><paragraph>BODY AS A WHOLE </paragraph></td><td styleCode="Lrule Toprule " valign="top"><paragraph>7</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>(8.2)</paragraph></td><td styleCode="Lrule Toprule " valign="top"><paragraph>6</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>(6.9)</paragraph></td><td styleCode="Lrule Toprule " valign="top"><paragraph>12</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>(14.1)</paragraph></td><td styleCode="Lrule Toprule " valign="top"><paragraph>25</paragraph></td><td styleCode="Toprule " valign="top"><paragraph>(9.7)</paragraph></td><td styleCode="Lrule Toprule " valign="top"><paragraph>15</paragraph></td><td styleCode="Rrule Toprule " valign="top"><paragraph>(11.8)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Headache </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td valign="top"><paragraph>(3.5)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2</paragraph></td><td valign="top"><paragraph>(2.3)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td valign="top"><paragraph>(3.5)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>8</paragraph></td><td valign="top"><paragraph>(3.1)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(2.4)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Common Cold </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>4</paragraph></td><td valign="top"><paragraph>(4.7)</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2</paragraph></td><td valign="top"><paragraph>(2.4)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>6 </paragraph></td><td valign="top"><paragraph>(2.3)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(2.4)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Allergy </paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2</paragraph></td><td valign="top"><paragraph>(2.3)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>1</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(1.6)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Infection Upper </paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2 </paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(1.6)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Respiratory</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td styleCode="Rrule " valign="top"/></tr><tr><td styleCode="Lrule " valign="top"><paragraph>MUSCULOSKELETAL</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>1</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>1</paragraph></td><td valign="top"><paragraph>(1.1)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>1</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>5</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(3.9)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Muscle Soreness</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2 </paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(1.6)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>RESPIRATORY </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>5</paragraph></td><td valign="top"><paragraph>(5.9)</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>1</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>6</paragraph></td><td valign="top"><paragraph>(2.3)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>6</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(4.7)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Sinusitis </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>4</paragraph></td><td valign="top"><paragraph>(4.7)</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>4</paragraph></td><td valign="top"><paragraph>(1.6)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2 </paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(1.6)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>SKIN & APPENDAGES </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>78</paragraph></td><td valign="top"><paragraph>(91.8)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>83</paragraph></td><td valign="top"><paragraph>(95.4)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>82</paragraph></td><td valign="top"><paragraph>(96.5)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>243</paragraph></td><td valign="top"><paragraph>(94.6)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>85</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(66.9)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Application Site </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>78</paragraph></td><td valign="top"><paragraph>(91.8)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>83</paragraph></td><td valign="top"><paragraph>(95.4)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>82</paragraph></td><td valign="top"><paragraph>(96.5)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>243 </paragraph></td><td valign="top"><paragraph>(94.6)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>83</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(65.4)</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Reaction </paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td valign="top"/><td styleCode="Lrule " valign="top"/><td styleCode="Rrule " valign="top"/></tr><tr><td styleCode="Lrule " valign="top"><paragraph>Irritation Skin </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>1</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"/><td valign="top"><paragraph>0</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>2</paragraph></td><td valign="top"><paragraph>(2.4)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>3</paragraph></td><td valign="top"><paragraph>(1.2)</paragraph></td><td styleCode="Lrule " valign="top"/><td styleCode="Rrule " valign="top"><paragraph>0</paragraph></td></tr><tr><td styleCode="Lrule " valign="top"><paragraph>SPECIAL SENSES </paragraph></td><td styleCode="Lrule " valign="top"><paragraph>6</paragraph></td><td valign="top"><paragraph>(7.1)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>4</paragraph></td><td valign="top"><paragraph>(4.6)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>6</paragraph></td><td valign="top"><paragraph>(7.1)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>16</paragraph></td><td valign="top"><paragraph>(6.2)</paragraph></td><td styleCode="Lrule " valign="top"><paragraph>6</paragraph></td><td styleCode="Rrule " valign="top"><paragraph>(4.7)</paragraph></td></tr><tr><td styleCode="Botrule Lrule " valign="top"><paragraph>Eye Irritation </paragraph></td><td styleCode="Botrule Lrule " valign="top"><paragraph>5</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>(5.9)</paragraph></td><td styleCode="Botrule Lrule " valign="top"><paragraph>3</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>(3.4)</paragraph></td><td styleCode="Botrule Lrule " valign="top"><paragraph>6</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>(7.1)</paragraph></td><td styleCode="Botrule Lrule " valign="top"><list listType="ordered"><item><caption> </caption>14</item></list></td><td styleCode="Botrule " valign="top"><paragraph>(5.4)</paragraph></td><td styleCode="Botrule Lrule " valign="top"><paragraph>3</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>(2.4)</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.