FDA label 453c9f61-1902-44ab-e063-6394a90ab639

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453c9f61-1902-44ab-e063-6394a90ab639
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boxed warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo . Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. In clinical trials, higher rates of suicidal thoughts and behavior were reported in patients treated with Qelbree than in patients treated with placebo. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Blood Pressure and Heart Rate Increases: Assess heart rate and blood pressure prior to initiating treatment, following increases in dosage, and periodically while on therapy ( 5.2 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder ( 5.3 ) Somnolence and Fatigue: Advise patients to use caution when driving or operating hazardous machinery due to potential somnolence (including sedation and lethargy) and fatigue ( 5.4 ) 5.1 Suicidal Thoughts and Behaviors Higher rates of suicidal thoughts and behaviors were reported in pediatric and adult patients with ADHD treated with Qelbree than in patients treated with placebo. Among 1019 pediatric patients exposed to Qelbree 100 mg to 400 mg in short-term trials, a total of nine patients (0.9%) reported suicidal ideation (N=6), behavior (N=1) or both (N=2). Eight patients reported suicidal ideation or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS), a validated scale that assesses suicide risk. An additional patient treated with Qelbree reported suicidal behavior during the clinical trials, but did not report it on the C-SSRS. Among 463 patients treated with placebo in these studies, two patients (0.4%) reported suicidal ideation on the C-SSRS. No patients treated with placebo reported suicidal behavior. No completed suicides occurred in these trials. Among 189 adults treated with Qelbree, a total of three patients (1.6%) reported suicidal ideation on the C-SSRS, versus 0 of 183 adults treated with placebo. No adults treated with either Qelbree or placebo reported suicidal behavior on the C-SSRS in the study. No attempted or completed suicides occurred in the trial. Patients treated with Qelbree had higher rates of insomnia and irritability [see Adverse Reactions (6.1) ] . Although a causal link between the emergence of insomnia and irritability and the emergence of suicidal impulses has not been established, there is a concern that these and other symptoms such as depressed mood, anxiety, agitation, akathisia, mania, hypomania, panic attacks, impulsive behavior, and aggression may represent precursors to emerging suicidal ideation or behavior. Thus, patients being treated with Qelbree should be observed for the emergence of precursor symptoms. Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Consider changing the therapeutic regimen, including possibly discontinuing Qelbree, in patients who are experiencing emergent suicidal thoughts and behaviors or symptoms that might be precursors to emerging suicidal ideation or behavior, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms. Advise family members or caregivers of patients to monitor for the emergence of suicidal ideation or behavior, and to report such symptoms immediately to the healthcare provider. 5.2 Blood Pressure and Heart Rate Increases Qelbree can cause an increase in heart rate and diastolic blood pressure. Pediatric Patients In a clinical study in pediatric patients 6 to 11 years of age, 34/154 (22%) of patients treated with Qelbree 100 mg daily had a ≥20 beat per minute (bpm) increase in heart rate at any time point in the clinical trial, compared to 15/159 (9%) of patients who received placebo. This finding was observed in 84/268 (31%) who received the 200 mg daily dosage, compared to 39/262 (15%) of patients in the placebo group, and in 28/100 (28%) of patients who received the 400 mg daily dosage, compared to 24/103 (23%) of patients who received placebo. In a clinical study in pediatric patients 12 to 17 years of age, 22/99 (22%) of patients treated with Qelbree 200 mg daily had a ≥20 bpm increase in heart rate at any time point in the clinical trial, compared to 15/104 (14%) of patients who received placebo. This finding was observed in 69/205 (34%) who received the 400 mg daily dosage, compared to 35/201 (17%) of patients in the placebo group. In pediatric patients 12 to 17 years of age, 52/205 (25%) of patients treated with Qelbree 400 mg daily had a ≥ 15 mmHg increase in diastolic blood pressure at any time in the clinical trial, compared to 26/201 (13%) of patients in the placebo group. Adult Patients In a clinical study in adult patients (18 to 60 years of age), 52/178 (29%) of patients treated daily with Qelbree (200 mg to 600 mg) had a ≥20 beat per minute (bpm) increase in heart rate at any time point in the clinical trial, compared to 23/181 (13%) of patients who received placebo. Of patients treated daily with Qelbree (200 to 600 mg), 23/178 (13%) had a ≥ 15 mmHg increase in diastolic blood pressure at any time in the clinical trial, compared to 16/181 (9%) of patients in the placebo group. Assess heart rate and blood pressure prior to initiating treatment with Qelbree, following increases in dosage, and periodically while on therapy [see Dosage and Administration (2.1) ] . 5.3 Activation of Mania or Hypomania Noradrenergic drugs, such as Qelbree, may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression [see Dosage and Administration (2.1) ]. 5.4 Somnolence and Fatigue Qelbree can cause somnolence and fatigue. In the short-term, placebo-controlled clinical trials in pediatric patients (6 to 17 years) with ADHD, somnolence (including lethargy and sedation) was reported in 16% of Qelbree-treated patients compared to 4% of placebo-treated patients. Fatigue was reported in 6% of Qelbree-treated patients, compared to 2% of placebo-treated patients [see Adverse Reactions (6.1) ]. In adults, somnolence was reported in 6% of Qelbree-treated patients versus 2% in placebo-treated patients. Fatigue was reported in 12% of Qelbree-treated patients versus 3% of placebo-treated patients. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by Qelbree.

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adverse reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described in other sections of the labeling: Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1) ] Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5.2) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.3) ] Somnolence and Fatigue [see Warnings and Precautions (5.4) ] Most commonly observed adverse reactions (≥5% and at least twice the rate of placebo) were: Pediatric patients 6 to 17 years of age : somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability ( 6.1 ) Adult patients : insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Supernus Pharmaceuticals at 1-866-398-0833 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 practice. The safety of Qelbree has been evaluated in 1118 pediatric patients (6 to 17 years of age) with ADHD exposed to one or more doses in short-term (6 to 8 week), randomized, double-blind, placebo-controlled trials. A total of 682 pediatric patients 6 to 17 years of age were treated for at least 6 months, and 347 pediatric patients 6 to 17 years of age for at least 12 months with Qelbree. The safety of Qelbree has been evaluated in 189 adult patients (18 to 60 years of age) with ADHD exposed to one or more doses in a short-term (6 week), randomized, double-blind, placebo-controlled trial. A total of 277 adult patients with ADHD have been exposed to one or more doses of Qelbree. Eighty-four adult patients were treated for at least 6 months, and 22 adult patients for at least 12 months. Pediatric Patients (6 to 17 Years of Age) The data described below reflect exposure to Qelbree in 826 pediatric patients (6 to 17 years) who participated in randomized, double-blind, placebo-controlled trials with doses ranging from 100 mg to 400 mg. The population (N=826) was 65% male, 35% female, 54% White, 41% Black, 4% multiracial, and 1% other races. Adverse Reactions Leading to Discontinuation of Qelbree Treatment : Approximately 3% (n=27) of the 826 patients receiving Qelbree in clinical studies discontinued treatment due to an adverse reaction. The adverse reactions most commonly associated with discontinuation of Qelbree were somnolence (n=5), nausea (n=3), headache (n=2), irritability (n=2), tachycardia (n=2), fatigue (n=2), and decreased appetite (n=2). Most Common Adverse Reactions (occurring at ≥5% and at least twice the placebo rate for any dose) : somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. Table 1 lists adverse reactions that occurred in at least 2% of patients treated with Qelbree and more frequently in Qelbree-treated patients than in placebo-treated patients. Table 1 data represents pooled data from pediatric patients 6 to 17 years of age who were enrolled in randomized, placebo-controlled trials of Qelbree. Table 1. Adverse Reactions Reported in ≥2% of Pediatric Patients (6 to 17 Years of Age) Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in Placebo-Controlled ADHD Studies Qelbree Body System Adverse Reaction Placebo N=463 (%) 100mg N=154 (%) 200mg N=367 (%) 400mg N=305 (%) All Qelbree N=826 (%) Nervous system disorders Somnolence The following terms were combined: Somnolence: somnolence, lethargy, sedation Headache: headache, migraine, migraine with aura, tension headache Upper respiratory tract infection: nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, viral sinusitis, viral upper respiratory tract infection Abdominal pain: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia 4 12 16 19 16 Headache 7 10 11 11 11 Metabolic and nutritional disorders Decreased appetite 0.4 5 8 8 7 Infections and infestations Upper respiratory tract infection 6 5 7 8 7 Body as a Whole - General disorders Fatigue 2 4 5 9 6 Pyrexia 0.2 3 2 1 2 Gastrointestinal system disorders Abdominal Pain 4 3 6 7 5 Nausea 3 1 4 7 5 Vomiting 2 5 3 6 4 Psychiatric disorders Insomnia 1 2 5 5 4 Irritability 1 3 2 5 3 Effects on Weight: In short–term, controlled studies (6 to 8 weeks), Qelbree-treated patients 6 to 11 years of age gained an average of 0.2 kg, compared to a gain of 1 kg in same-aged patients who received placebo. Qelbree-treated patients 12 to 17 years of age lost an average of 0.2 kg, compared to a weight gain of 1.5 kg in same-aged patients who received placebo. In a long-term open-label extension safety trial, 1097 patients received at least 1 dose of Qelbree. Among the 338 patients evaluated at 12 months, the mean change from baseline in weight-for-age z-score was -0.2 (standard deviation of 0.5). In the absence of a control group, it is unclear whether the weight change observed in the long-term open-label extension was attributable to the effect of Qelbree. Adults The data described below reflect exposure to Qelbree in 189 adults with ADHD who participated in the flexible-dose, randomized, double-blind, placebo-controlled trial with doses ranging from 200 mg to 600 mg. The population (N=189) was 56% male, 44% female, 81% White, 12% Black, 3% Asian, 3% other races and 1% multiracial. Adverse Reactions Leading to Discontinuation of Qelbree Treatment : Approximately 9% of the 189 patients receiving Qelbree in clinical studies discontinued treatment due to an adverse reaction. The adverse reactions most commonly associated with discontinuation of Qelbree were fatigue (n=4), insomnia (n=3), constipation (n=3), and headache (n=2). Most Common Adverse Reactions (occurring at ≥5% and at least twice the placebo rate of Qelbree): insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. Table 2 lists adverse reactions that occurred in at least 2% of patients treated with Qelbree and more frequently in Qelbree-treated patients than in placebo-treated patients. Table 2 represents data from adults with ADHD who were enrolled in a flexible-dose, randomized, placebo-controlled trial of Qelbree at doses of 200 mg to 600 mg. Table 2. Adverse Reactions Reported in ≥2% of Adults Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in a Flexible-Dose Placebo-Controlled ADHD Study Body System Adverse Reaction Placebo N=183 (%) Qelbree (200 mg to 600 mg) N=189 (%) Psychiatric disorders Insomnia The following terms were combined: Somnolence: somnolence, lethargy, sedation Headache: headache, migraine, migraine with aura, tension headache Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia 7 23 Irritability 3 4 Nervous system disorders Headache 7 17 Somnolence 2 6 Dizziness 2 4 Gastrointestinal system disorders Nausea 3 12 Dry mouth 2 10 Constipation 1 6 Vomiting 1 4 Gastrooesophageal reflux disease 1 2 Body as a Whole - General disorders Fatigue 3 12 Metabolic and nutritional disorders Decreased appetite 3 10 Cardiac Disorders Tachycardia 1 4

adverse reactions table

<table width="95%"><caption>Table 1. Adverse Reactions Reported in &#x2265;2% of Pediatric Patients (6 to 17 Years of Age) Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in Placebo-Controlled ADHD Studies</caption><col width="25%" align="left" valign="top"/><col width="12%" align="center" valign="top"/><col width="13%" align="center" valign="top"/><col width="12%" align="center" valign="top"/><col width="13%" align="center" valign="top"/><col width="25%" align="center" valign="top"/><thead><tr><th styleCode="Lrule Rrule"/><th styleCode="Rrule"/><th colspan="4" styleCode="Rrule Botrule">Qelbree</th></tr><tr><th styleCode="Lrule Rrule" valign="middle">Body System Adverse Reaction </th><th styleCode="Rrule">Placebo N=463 (%) </th><th styleCode="Rrule">100mg N=154 (%) </th><th styleCode="Rrule">200mg N=367 (%) </th><th styleCode="Rrule">400mg N=305 (%) </th><th styleCode="Rrule">All Qelbree N=826 (%) </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Nervous system disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Somnolence <footnote ID="t1f1">The following terms were combined: Somnolence: somnolence, lethargy, sedation Headache: headache, migraine, migraine with aura, tension headache Upper respiratory tract infection: nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, viral sinusitis, viral upper respiratory tract infection Abdominal pain: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia</footnote></content></td><td styleCode="Rrule">4</td><td styleCode="Rrule">12</td><td styleCode="Rrule">16</td><td styleCode="Rrule">19</td><td styleCode="Rrule">16</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Headache <footnoteRef IDREF="t1f1"/></content></td><td styleCode="Rrule">7</td><td styleCode="Rrule">10</td><td styleCode="Rrule">11</td><td styleCode="Rrule">11</td><td styleCode="Rrule">11</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Metabolic and nutritional disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Decreased appetite</content></td><td styleCode="Rrule">0.4</td><td styleCode="Rrule">5</td><td styleCode="Rrule">8</td><td styleCode="Rrule">8</td><td styleCode="Rrule">7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Infections and infestations</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Upper respiratory tract infection <footnoteRef IDREF="t1f1"/></content></td><td styleCode="Rrule">6</td><td styleCode="Rrule">5</td><td styleCode="Rrule">7</td><td styleCode="Rrule">8</td><td styleCode="Rrule">7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Body as a Whole - General disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Fatigue</content></td><td styleCode="Rrule">2</td><td styleCode="Rrule">4</td><td styleCode="Rrule">5</td><td styleCode="Rrule">9</td><td styleCode="Rrule">6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Pyrexia</content></td><td styleCode="Rrule">0.2</td><td styleCode="Rrule">3</td><td styleCode="Rrule">2</td><td styleCode="Rrule">1</td><td styleCode="Rrule">2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Gastrointestinal system disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Abdominal Pain <footnoteRef IDREF="t1f1"/></content></td><td styleCode="Rrule">4</td><td styleCode="Rrule">3</td><td styleCode="Rrule">6</td><td styleCode="Rrule">7</td><td styleCode="Rrule">5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Nausea</content></td><td styleCode="Rrule">3</td><td styleCode="Rrule">1</td><td styleCode="Rrule">4</td><td styleCode="Rrule">7</td><td styleCode="Rrule">5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Vomiting</content></td><td styleCode="Rrule">2</td><td styleCode="Rrule">5</td><td styleCode="Rrule">3</td><td styleCode="Rrule">6</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Psychiatric disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Insomnia <footnoteRef IDREF="t1f1"/></content></td><td styleCode="Rrule">1</td><td styleCode="Rrule">2</td><td styleCode="Rrule">5</td><td styleCode="Rrule">5</td><td styleCode="Rrule">4</td></tr><tr><td styleCode="Lrule Rrule"><content styleCode="bold">Irritability</content></td><td styleCode="Rrule">1</td><td styleCode="Rrule">3</td><td styleCode="Rrule">2</td><td styleCode="Rrule">5</td><td styleCode="Rrule">3</td></tr></tbody></table>

adverse reactions table

<table width="75%"><caption>Table 2. Adverse Reactions Reported in &#x2265;2% of Adults Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in a Flexible-Dose Placebo-Controlled ADHD Study</caption><col width="34%" align="left" valign="top"/><col width="33%" align="center" valign="top"/><col width="33%" align="center" valign="top"/><thead><tr><th styleCode="Lrule Rrule">Body System Adverse Reaction </th><th styleCode="Rrule">Placebo N=183 (%) </th><th styleCode="Rrule">Qelbree (200 mg to 600 mg) N=189 (%) </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Psychiatric disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Insomnia <footnote ID="t2f1">The following terms were combined: Somnolence: somnolence, lethargy, sedation Headache: headache, migraine, migraine with aura, tension headache Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia</footnote></td><td styleCode="Rrule">7</td><td styleCode="Rrule">23</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Irritability</td><td styleCode="Rrule">3</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Nervous system disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Headache <footnoteRef IDREF="t2f1"/></td><td styleCode="Rrule">7</td><td styleCode="Rrule">17</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Somnolence <footnoteRef IDREF="t2f1"/></td><td styleCode="Rrule">2</td><td styleCode="Rrule">6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dizziness</td><td styleCode="Rrule">2</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Gastrointestinal system disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nausea</td><td styleCode="Rrule">3</td><td styleCode="Rrule">12</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dry mouth</td><td styleCode="Rrule">2</td><td styleCode="Rrule">10</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Constipation</td><td styleCode="Rrule">1</td><td styleCode="Rrule">6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Vomiting</td><td styleCode="Rrule">1</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Gastrooesophageal reflux disease</td><td styleCode="Rrule">1</td><td styleCode="Rrule">2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Body as a Whole - General disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Fatigue</td><td styleCode="Rrule">3</td><td styleCode="Rrule">12</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Metabolic and nutritional disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased appetite</td><td styleCode="Rrule">3</td><td styleCode="Rrule">10</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Cardiac Disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Tachycardia</td><td styleCode="Rrule">1</td><td styleCode="Rrule">4</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.