FDA label 416b40c0-a1a3-4f0e-88e2-fb96e93e024e

5 WARNINGS AND PRECAUTIONS Hypersensitivity : Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of apremilast in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue apremilast and institute appropriate therapy ( 5.1 ). Diarrhea, Nausea, and Vomiting : Consider apremilast dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting ( 5.2 ) Depression : Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with apremilast in patients with a history of depression and/or suicidal thoughts or behavior ( 5.3 ) Weight Decrease : Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of apremilast ( 5.4 ) Drug Interactions : Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur ( 5.5 , 7.1 ) 5.1 Hypersensitivity Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported during post marketing surveillance. Avoid the use of apremilast in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue apremilast and institute appropriate therapy. 5.2 Diarrhea, Nausea, and Vomiting There have been reports of severe diarrhea, nausea, and vomiting associated with the use of apremilast. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting. Patients who reduced dosage or discontinued apremilast generally improved quickly. Consider apremilast dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting. 5.3 Depression Treatment with apremilast is associated with an increased incidence of depression. Before using apremilast in patients with a history of depression and/or suicidal thoughts or behavior, carefully weigh the risks and benefits of treatment with apremilast. Advise patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully evaluate the risks and benefits of continuing treatment with apremilast if such events occur. Psoriatic Arthritis : During the 16-week placebo-controlled period of the 3 controlled clinical trials, 1.0% (10/998) of subjects treated with apremilast reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. During the clinical trials, 0.3% (4/1,441) of subjects treated with apremilast discontinued treatment due to depression or depressed mood compared with none in placebo treated subjects (0/495). Depression was reported as serious in 0.2% (3/1,441) of subjects exposed to apremilast, compared to none in placebo-treated subjects (0/495). Instances of suicidal ideation and behavior have been observed in 0.2% (3/1,441) of subjects while receiving apremilast, compared to none in placebo treated subjects (0/495). In the clinical trials, 2 subjects who received placebo committed suicide compared to none in apremilast-treated subjects. Plaque Psoriasis : During the 16-week placebo-controlled period of the 3 controlled clinical trials in adult subjects with moderate to severe plaque psoriasis, 1.3% (12/920) of subjects treated with apremilast reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1,308) of subjects treated with apremilast discontinued treatment due to depression compared with none in placebo-treated subjects (0/506). Depression was reported as serious in 0.1% (1/1,308) of subjects exposed to apremilast, compared to none in placebo-treated subjects (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1,308) of subjects while receiving apremilast, compared to 0.2% (1/506) in placebo-treated subjects. In the clinical trials, one subject treated with apremilast attempted suicide while one who received placebo committed suicide. During the 16-week placebo-controlled period of the clinical trial in adults with mild to moderate plaque psoriasis, the incidence of subjects reporting depression was similar to what was observed in the adult moderate to severe plaque psoriasis trials. 5.4 Weight Decrease Weight loss may occur in adult or pediatric patients treated with apremilast tablets. Regularly monitor the weight of patients treated with apremilast tablets. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of apremilast tablets [see Adverse Reactions ( 6.1 )] . Weight Loss in Adult Patients During the placebo-controlled period of the trials in psoriatic arthritis (PsA), weight decrease between 5% to 10% of body weight was reported in 10% (49/497) of subjects treated with apremilast tablets 30 mg twice daily compared to 3.3% (16/495) treated with placebo. During the placebo-controlled period of the trials in adults with moderate to severe plaque psoriasis, weight decrease between 5% to 10% of body weight occurred in 12% (96/784) of subjects treated with apremilast compared to 5% (19/382) treated with placebo. Weight decrease of ≥ 10% of body weight occurred in 2% (16/784) of subjects treated with apremilast 30 mg twice daily compared to 1% (3/382) subjects treated with placebo. During the placebo-controlled period of the clinical trial in adults with mild to moderate plaque psoriasis, weight decrease was similar to what was observed in the trials of adults with moderate to severe plaque psoriasis. Pediatric use information is approved for Amgen Inc.'s Otezla (apremilast) Tablets. However, due to Amgen Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 5.5 Drug Interactions Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with apremilast is not recommended [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions ( 5.1 )] Diarrhea, Nausea, and Vomiting [see Warnings and Precautions ( 5.2 )] Depression [see Warnings and Precautions ( 5.3 )] Weight Decrease [see Warnings and Precautions ( 5.4 )] Drug Interactions [see Warnings and Precautions ( 5.5 )] Psoriatic Arthritis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Psoriatic Arthritis Clinical Trials Apremilast was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled trials (PsA-1, PsA-2, and PsA-3) of similar design in adult subjects with active psoriatic arthritis [see Clinical Studies ( 14.1 )] . Across the 3 trials, there were 1,493 subjects randomized equally to placebo, apremilast 20 mg twice daily or apremilast 30 mg twice daily. Titration was used over the first 5 days [see Dosage and Administration ( 2.1 )] . Placebo subjects whose tender and swollen joint counts had not improved by at least 20% were re-randomized 1:1 in a blinded fashion to either apremilast 20 mg twice daily or 30 mg twice daily at week 16 while apremilast subjects remained on their initial treatment. Subjects ranged in age from 18 to 83 years, with an overall median age of 51 years. The majority of the most common adverse reactions presented in Table 3 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking apremilast were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of subjects with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for subjects taking apremilast 30 mg twice daily and 1.2% for placebo-treated subjects. Table 3: Adverse Reactions Reported in ≥ 2% of Adult Subjects with Active Psoriatic Arthritis on apremilast 30 mg Twice Daily and ≥ 1% than That Observed in Subjects on Placebo up to Day 112 (Week 16) a Of the reported gastrointestinal adverse reactions, 1 subject experienced a serious adverse reaction of nausea and vomiting in apremilast 30 mg twice daily; 1 subject treated with apremilast 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 subject treated with apremilast 30 mg twice daily experienced a serious adverse reaction of headache. b Of the reported adverse drug reactions none were serious. c n (%) indicates number of subjects and percent. d BID = twice daily. Placebo Apremilast 30 mg BID d Adverse Reactions Day 1 to 5 (N = 495) n (%) c Day 6 to Day 112 (N = 490) n (%) Day 1 to 5 (N = 497) n (%) Day 6 to Day 112 (N = 493) n (%) Diarrhea a 6 (1.2) 8 (1.6) 46 (9.3) 38 (7.7) Nausea a 7 (1.4) 15 (3.1) 37 (7.4) 44 (8.9) Headache a 9 (1.8) 11 (2.2) 24 (4.8) 29 (5.9) Upper respiratory tract infection b 3 (0.6) 9 (1.8) 3 (0.6) 19 (3.9) Vomiting a 2 (0.4) 2 (0.4) 4 (0.8) 16 (3.2) Nasopharyngitis b 1 (0.2) 8 (1.6) 1 (0.2) 13 (2.6) Abdominal pain upper b 0 (0.0) 1 (0.2) 3 (0.6) 9 (2.0) Moderate to Severe Plaque Psoriasis Clinical Trials Adverse Reactions from Clinical Trials in Adults The safety of apremilast was assessed in 1,426 subjects in 3 randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive apremilast 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days [see Dosage and Administration ( 2.1 )] . Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years. Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions (see Table 4). The most common adverse reactions leading to discontinuation for subjects taking apremilast were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with plaque psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with apremilast 30 mg twice daily and 4.1% for placebo-treated subjects. Table 4: Adverse Reactions Reported in ≥1% of Adult Subjects with Moderate to Severe Plaque Psoriasis on apremilast and With Greater Frequency Than in Subjects on Placebo up to Day 112 (Week 16) a Two subjects treated with apremilast experienced serious adverse reaction of abdominal pain. b BID = twice daily. Adverse Reactions Placebo (N = 506) n (%) Apremilast 30 mg BID b (N = 920) n (%) Diarrhea 32 (6) 160 (17) Nausea 35 (7) 155 (17) Upper respiratory tract infection 31 (6) 84 (9) Tension headache 21 (4) 75 (8) Headache 19 (4) 55 (6) Abdominal pain a 11 (2) 39 (4) Vomiting 8 (2) 35 (4) Fatigue 9 (2) 29 (3) Dyspepsia 6 (1) 29 (3) Decreased appetite 5 (1) 26 (3) Insomnia 4 (1) 21 (2) Back pain 4 (1) 20 (2) Migraine 5 (1) 19 (2) Frequent bowel movements 1 (0) 17 (2) Depression 2 (0) 12 (1) Bronchitis 2 (0) 12 (1) Tooth abscess 0 (0) 10 (1) Folliculitis 0 (0) 9 (1) Sinus headache 0 (0) 9 (1) Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1,184) subjects following discontinuation of treatment with apremilast. Apremilast was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-3) in adults with moderate to severe plaque psoriasis of the scalp [see Clinical Studies ( 14.2 )] . A total of 302 subjects were randomized to receive apremilast 30 mg twice daily or placebo twice daily. The most commonly reported adverse reactions that occurred at a higher rate in the apremilast group than in the placebo group were: diarrhea (31% vs. 11%), nausea (22% vs. 6%), headache (12% vs. 5%), and vomiting (6% vs. 2%). The proportion of subjects who discontinued treatment because of any adverse reaction during the 16-week placebo-controlled period of the trial was 6% for subjects who received apremilast 30 mg twice daily and 3% for subjects who received placebo. Gastrointestinal adverse reactions that led to discontinuation of treatment were diarrhea (3% vs. 0%), nausea (1.5% vs. 1%), and vomiting (1.5% vs. 0 %) in the apremilast group compared to placebo. Mild to Moderate Plaque Psoriasis Clinical Trial in Adults Apremilast was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-4) in adult subjects with mild to moderate plaque psoriasis [see Clinical Studies ( 14.3 )] . A total of 595 subjects were randomized to receive apremilast 30 mg twice daily (297 subjects) or placebo twice daily (298 subjects) during the placebo-controlled phase of the trial. The trial also included an open label extension phase during which all subjects received apremilast 30 mg twice daily. Overall, the safety profile observed in the apremilast group during the placebo-controlled phase was consistent with the safety profile previously established in adult subjects with moderate to severe plaque psoriasis. Other adverse reactions reported in subjects on apremilast in psoriatic arthritis and plaque psoriasis clinical trials are : Gastrointestinal Disorders: Gastroesophageal reflux disease Immune System Disorders: Hypersensitivity Investigations: Weight decrease Metabolism and Nutrition Disorders: Decreased appetite* Nervous System Disorders: Migraine Respiratory, Thoracic, and Mediastinal Disorders: Cough Skin and Subcutaneous Tissue Disorders: Rash *1 subject treated with apremilast 30 mg twice daily experienced a serious adverse reaction. Pediatric use information is approved for Amgen Inc.'s Otezla (apremilast) Tablets. However, due to Amgen Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

<table ID="ID44" width="100%"><caption> Table 3: Adverse Reactions Reported in &#x2265; 2% of Adult Subjects with Active Psoriatic Arthritis on apremilast 30 mg Twice Daily and &#x2265; 1% than That Observed in Subjects on Placebo up to Day 112 (Week 16)</caption><colgroup><col width="25%"/><col width="16%"/><col width="21%"/><col width="17%"/><col width="19%"/></colgroup><tfoot><tr><td colspan="5" align="left"><paragraph styleCode="First Footnote">^aOf the reported gastrointestinal adverse reactions, 1 subject experienced a serious adverse reaction of nausea and vomiting in apremilast 30 mg twice daily; 1 subject treated with apremilast 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 subject treated with apremilast 30 mg twice daily experienced a serious adverse reaction of headache.</paragraph></td></tr><tr><td colspan="5" align="left"><paragraph styleCode="First Footnote">^b Of the reported adverse drug reactions none were serious.</paragraph></td></tr><tr><td colspan="5" align="left"><paragraph styleCode="First Footnote">^c n (%) indicates number of subjects and percent.</paragraph></td></tr><tr><td colspan="5" align="left"><paragraph styleCode="First Footnote">^d BID = twice daily.</paragraph></td></tr></tfoot><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"/><td styleCode="Botrule Rrule Toprule" colspan="2" align="center"><content styleCode="bold"> Placebo</content></td><td styleCode="Botrule Rrule Toprule" colspan="2" align="center"><content styleCode="bold"> Apremilast</content><content styleCode="bold"> 30 mg BID^d</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="center"><content styleCode="bold"> Adverse Reactions</content></td><td styleCode="Botrule Rrule" align="center"><content styleCode="bold"> Day 1 to 5</content> <content styleCode="bold"> (N = 495)</content> <content styleCode="bold"> n (%)^c</content></td><td styleCode="Botrule Rrule" align="center"><content styleCode="bold"> Day 6 to Day </content> <content styleCode="bold"> 112 (N = 490) </content> <content styleCode="bold"> n (%)</content></td><td styleCode="Botrule Rrule" align="center"><content styleCode="bold"> Day 1 to 5 </content> <content styleCode="bold"> (N = 497) </content> <content styleCode="bold"> n (%)</content></td><td styleCode="Botrule Rrule" align="center"><content styleCode="bold"> Day 6 to Day</content> <content styleCode="bold"> 112 (N = 493)</content> <content styleCode="bold"> n (%)</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Diarrhea^a</td><td styleCode="Botrule Rrule" align="center">6 (1.2)</td><td styleCode="Botrule Rrule" align="center">8 (1.6)</td><td styleCode="Botrule Rrule" align="center">46 (9.3)</td><td styleCode="Botrule Rrule" align="center">38 (7.7)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Nausea^a</td><td styleCode="Botrule Rrule" align="center">7 (1.4)</td><td styleCode="Botrule Rrule" align="center">15 (3.1)</td><td styleCode="Botrule Rrule" align="center">37 (7.4)</td><td styleCode="Botrule Rrule" align="center">44 (8.9)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Headache^a</td><td styleCode="Botrule Rrule" align="center">9 (1.8)</td><td styleCode="Botrule Rrule" align="center">11 (2.2)</td><td styleCode="Botrule Rrule" align="center">24 (4.8)</td><td styleCode="Botrule Rrule" align="center">29 (5.9)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Upper respiratory tract infection^b</td><td styleCode="Botrule Rrule" align="center">3 (0.6)</td><td styleCode="Botrule Rrule" align="center">9 (1.8)</td><td styleCode="Botrule Rrule" align="center">3 (0.6)</td><td styleCode="Botrule Rrule" align="center">19 (3.9)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Vomiting^a</td><td styleCode="Botrule Rrule" align="center">2 (0.4)</td><td styleCode="Botrule Rrule" align="center">2 (0.4)</td><td styleCode="Botrule Rrule" align="center">4 (0.8)</td><td styleCode="Botrule Rrule" align="center">16 (3.2)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Nasopharyngitis^b</td><td styleCode="Botrule Rrule" align="center">1 (0.2)</td><td styleCode="Botrule Rrule" align="center">8 (1.6)</td><td styleCode="Botrule Rrule" align="center">1 (0.2)</td><td styleCode="Botrule Rrule" align="center">13 (2.6)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Abdominal pain upper^b</td><td styleCode="Botrule Rrule" align="center">0 (0.0)</td><td styleCode="Botrule Rrule" align="center">1 (0.2)</td><td styleCode="Botrule Rrule" align="center">3 (0.6)</td><td styleCode="Botrule Rrule" align="center">9 (2.0)</td></tr></tbody></table>

<table ID="ID46" width="100%"><caption> Table 4: Adverse Reactions Reported in &#x2265;1% of Adult Subjects with Moderate to Severe Plaque Psoriasis on apremilast and With Greater Frequency Than in Subjects on Placebo up to Day 112 (Week 16)</caption><colgroup><col width="47%"/><col width="23%"/><col width="28%"/></colgroup><tfoot><tr><td colspan="3" align="left"><paragraph styleCode="First Footnote">^aTwo subjects treated with apremilast experienced serious adverse reaction of abdominal pain.</paragraph></td></tr><tr><td colspan="3" align="left"><paragraph styleCode="First Footnote">^b BID = twice daily.</paragraph></td></tr></tfoot><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule" align="left"><content styleCode="bold"> Adverse Reactions</content></td><td styleCode="Botrule Rrule Toprule" align="center"><content styleCode="bold"> Placebo </content> <content styleCode="bold"> (N = 506)</content> <content styleCode="bold"> n (%)</content></td><td styleCode="Botrule Rrule Toprule" align="center"><content styleCode="bold"> Apremilast</content><content styleCode="bold"> 30 mg BID^b</content> <content styleCode="bold"> (N = 920) </content> <content styleCode="bold"> n (%)</content></td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Diarrhea</td><td styleCode="Botrule Rrule" align="center">32 (6)</td><td styleCode="Botrule Rrule" align="center">160 (17)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Nausea</td><td styleCode="Botrule Rrule" align="center">35 (7)</td><td styleCode="Botrule Rrule" align="center">155 (17)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Upper respiratory tract infection</td><td styleCode="Botrule Rrule" align="center">31 (6)</td><td styleCode="Botrule Rrule" align="center">84 (9)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Tension headache</td><td styleCode="Botrule Rrule" align="center">21 (4)</td><td styleCode="Botrule Rrule" align="center">75 (8)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Headache</td><td styleCode="Botrule Rrule" align="center">19 (4)</td><td styleCode="Botrule Rrule" align="center">55 (6)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Abdominal pain ^a</td><td styleCode="Botrule Rrule" align="center">11 (2)</td><td styleCode="Botrule Rrule" align="center">39 (4)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Vomiting</td><td styleCode="Botrule Rrule" align="center">8 (2)</td><td styleCode="Botrule Rrule" align="center">35 (4)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Fatigue</td><td styleCode="Botrule Rrule" align="center">9 (2)</td><td styleCode="Botrule Rrule" align="center">29 (3)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Dyspepsia</td><td styleCode="Botrule Rrule" align="center">6 (1)</td><td styleCode="Botrule Rrule" align="center">29 (3)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Decreased appetite</td><td styleCode="Botrule Rrule" align="center">5 (1)</td><td styleCode="Botrule Rrule" align="center">26 (3)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Insomnia</td><td styleCode="Botrule Rrule" align="center">4 (1)</td><td styleCode="Botrule Rrule" align="center">21 (2)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Back pain</td><td styleCode="Botrule Rrule" align="center">4 (1)</td><td styleCode="Botrule Rrule" align="center">20 (2)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Migraine</td><td styleCode="Botrule Rrule" align="center">5 (1)</td><td styleCode="Botrule Rrule" align="center">19 (2)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Frequent bowel movements</td><td styleCode="Botrule Rrule" align="center">1 (0)</td><td styleCode="Botrule Rrule" align="center">17 (2)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Depression</td><td styleCode="Botrule Rrule" align="center">2 (0)</td><td styleCode="Botrule Rrule" align="center">12 (1)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Bronchitis</td><td styleCode="Botrule Rrule" align="center">2 (0)</td><td styleCode="Botrule Rrule" align="center">12 (1)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Tooth abscess</td><td styleCode="Botrule Rrule" align="center">0 (0)</td><td styleCode="Botrule Rrule" align="center">10 (1)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Folliculitis</td><td styleCode="Botrule Rrule" align="center">0 (0)</td><td styleCode="Botrule Rrule" align="center">9 (1)</td></tr><tr><td styleCode="Botrule Lrule Rrule" align="left">Sinus headache</td><td styleCode="Botrule Rrule" align="center">0 (0)</td><td styleCode="Botrule Rrule" align="center">9 (1)</td></tr></tbody></table>