FDA label ff667ed4-cca2-463d-b700-8b134a68d15a

SUICIDALITY IN CHILDREN AND ADOLESCENTS Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of DESYREL or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. DESYREL is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use ). Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well. No suicides occurred in any of these trials . It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, ie, beyond several months. It is also unknown whether the suicidality risk extends to adults. All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits. Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for DESYREL should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Families and caregivers of adults being treated for depression should be similarly advised. Screening Patients for Bipolar Disorder A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that DESYREL is not approved for use in treating bipolar depression. TRAZODONE HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF PRIAPISM. IN MANY OF THE CASES REPORTED, SURGICAL INTERVENTION WAS REQUIRED AND, IN A SOME OF THESE CASES, PERMANENT IMPAIRMENT OF ERECTILE FUNCTION OR IMPOTENCE RESULTED. MALE PATIENTS WITH PROLONGED OR INAPPROPRIATE ERECTIONS SHOULD IMMEDIATELY DISCONTINUE THE DRUG AND CONSULT THEIR PHYSICIAN. The detumescence of priapism and drug-induced penile erections has been accomplished by both pharmacologic, eg, the intracavernosal injection of alpha-adrenergic stimulants such as epinephrine and norepinephrine, as well as surgical procedures. 2-7 Any pharmacologic or surgical procedure utilized in the treatment of priapism should be performed under the supervision of a urologist or a physician familiar with the procedure and should not be initiated without urologic consultation if the priapism has persisted for more than 24 hours. DESYREL (trazodone hydrochloride) is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering DESYREL to patients with cardiac disease, and such patients should be closely monitored, since antidepressant drugs (including DESYREL) have been associated with the occurrence of cardiac arrhythmias. Recent clinical studies in patients with pre-existing cardiac disease indicate that DESYREL may be arrhythmogenic in some patients in that population. Arrhythmias identified include isolated PVCs, ventricular couplets, and in two patients, short episodes (3–4 beats) of ventricular tachycardia.

ADVERSE REACTIONS Because the frequency of adverse drug effects is affected by diverse factors (eg, drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with DESYREL. It is impossible to determine precisely what accounts for the differences observed. Clinical Trial Reports The table below is presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of DESYREL ® (trazodone hydrochloride). The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those which prevailed in the clinical trials. These incidence figures, also, cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials is conducted under a different set of conditions. Treatment-Emergent Symptom Incidence Inpts. Outpts. D P D P * Incidence less than 1% D = DESYREL P = PLACEBO Number of Patients 142 95 157 158 % of Patients Reporting Allergic Skin Condition/Edema 2.8 1.1 7.0 1.3 Autonomic Blurred Vision 6.3 4.2 14.7 3.8 Constipation 7.0 4.2 7.6 5.7 Dry Mouth 14.8 8.4 33.8 20.3 Cardiovascular Hypertension 2.1 1.1 1.3 * Hypotension 7.0 1.1 3.8 0.0 Shortness of Breath * 1.1 1.3 0.0 Syncope 2.8 2.1 4.5 1.3 Tachycardia/Palpitations 0.0 0.0 7.0 7.0 CNS Anger/Hostility 3.5 6.3 1.3 2.5 Confusion 4.9 0.0 5.7 7.6 Decreased Concentration 2.8 2.1 1.3 0.0 Disorientation 2.1 0.0 * 0.0 Dizziness/Lightheadedness 19.7 5.3 28.0 15.2 Drowsiness 23.9 6.3 40.8 19.6 Excitement 1.4 1.1 5.1 5.7 Fatigue 11.3 4.2 5.7 2.5 Headache 9.9 5.3 19.8 15.8 Insomnia 9.9 10.5 6.4 12.0 Impaired Memory 1.4 0.0 * * Nervousness 14.8 10.5 6.4 8.2 Gastrointestinal Abdominal/Gastric Disorder 3.5 4.2 5.7 4.4 Bad Taste in Mouth 1.4 0.0 0.0 0.0 Diarrhea 0.0 1.1 4.5 1.9 Nausea/Vomiting 9.9 1.1 12.7 9.5 Musculoskeletal Musculoskeletal Aches/Pains 5.6 3.2 5.1 2.5 Neurological Incoordination 4.9 0.0 1.9 0.0 Paresthesia 1.4 0.0 0.0 * Tremors 2.8 1.1 5.1 3.8 Sexual Function Decreased Libido * 1.1 1.3 * Other Decreased Appetite 3.5 5.3 0.0 * Eyes Red/Tired/Itching 2.8 0.0 0.0 0.0 Head Full-Heavy 2.8 0.0 0.0 0.0 Malaise 2.8 0.0 0.0 0.0 Nasal/Sinus Congestion 2.8 0.0 5.7 3.2 Nightmares/Vivid Dreams * 1.1 5.1 5.7 Sweating/Clamminess 1.4 1.1 * * Tinnitus 1.4 0.0 0.0 * Weight Gain 1.4 0.0 4.5 1.9 Weight Loss * 3.2 5.7 2.5 Occasional sinus bradycardia has occurred in long-term studies. In addition to the relatively common (ie, greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of DESYREL ® (trazodone hydrochloride) in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation. Post-Introduction Reports Although the following adverse reactions have been reported in DESYREL users, the causal association has neither been confirmed nor refuted. Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism (See WARNINGS and PRECAUTIONS : Information for Patients ; some patients have required surgical intervention), pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo and weakness. Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, and ventricular ectopic activity, including ventricular tachycardia (see WARNINGS ).

<table width="100%" ID="i0a99a9ef-e538-433c-8f2a-c15f51fee695"> <col align="left"/> <col align="center"/> <col align="center"/> <col align="center"/> <col align="center"/> <thead> <tr> <td align="center" colspan="5" styleCode="Lrule Rrule">Treatment-Emergent Symptom Incidence</td> </tr> <tr> <td styleCode="Lrule Toprule"/> <td colspan="2" styleCode="Lrule Toprule">Inpts.</td> <td colspan="2" styleCode="Lrule Toprule Rrule">Outpts.</td> </tr> <tr> <td styleCode="Lrule Toprule"/> <td styleCode="Lrule Toprule">D</td> <td styleCode="Lrule Toprule">P</td> <td styleCode="Lrule Toprule">D</td> <td styleCode="Lrule Toprule Rrule">P</td> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5">* Incidence less than 1%</td> </tr> <tr> <td align="left" colspan="5">D = DESYREL P = PLACEBO</td> </tr> </tfoot> <tbody> <tr> <td styleCode="Lrule">Number of Patients</td> <td styleCode="Lrule">142</td> <td styleCode="Lrule">95</td> <td styleCode="Lrule">157</td> <td styleCode="Lrule Rrule">158</td> </tr> <tr> <td styleCode="Lrule Toprule">% of Patients Reporting</td> <td styleCode="Lrule Toprule"/> <td styleCode="Lrule Toprule"/> <td styleCode="Lrule Toprule"/> <td styleCode="Lrule Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule">Allergic</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Skin Condition/Edema</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">7.0</td> <td styleCode="Lrule Toprule Rrule">1.3</td> </tr> <tr> <td styleCode="Lrule Toprule">Autonomic</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Blurred Vision</td> <td styleCode="Lrule Toprule">6.3</td> <td styleCode="Lrule Toprule">4.2</td> <td styleCode="Lrule Toprule">14.7</td> <td styleCode="Lrule Toprule Rrule">3.8</td> </tr> <tr> <td styleCode="Lrule Toprule"> Constipation</td> <td styleCode="Lrule Toprule">7.0</td> <td styleCode="Lrule Toprule">4.2</td> <td styleCode="Lrule Toprule">7.6</td> <td styleCode="Lrule Toprule Rrule">5.7</td> </tr> <tr> <td styleCode="Lrule Toprule"> Dry Mouth</td> <td styleCode="Lrule Toprule">14.8</td> <td styleCode="Lrule Toprule">8.4</td> <td styleCode="Lrule Toprule">33.8</td> <td styleCode="Lrule Toprule Rrule">20.3</td> </tr> <tr> <td styleCode="Lrule Toprule">Cardiovascular</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Hypertension</td> <td styleCode="Lrule Toprule">2.1</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">1.3</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule"> Hypotension</td> <td styleCode="Lrule Toprule">7.0</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">3.8</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Shortness of Breath</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">1.3</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Syncope</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">2.1</td> <td styleCode="Lrule Toprule">4.5</td> <td styleCode="Lrule Toprule Rrule">1.3</td> </tr> <tr> <td styleCode="Lrule Toprule"> Tachycardia/Palpitations</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">7.0</td> <td styleCode="Lrule Toprule Rrule">7.0</td> </tr> <tr> <td styleCode="Lrule Toprule">CNS</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Anger/Hostility</td> <td styleCode="Lrule Toprule">3.5</td> <td styleCode="Lrule Toprule">6.3</td> <td styleCode="Lrule Toprule">1.3</td> <td styleCode="Lrule Toprule Rrule">2.5</td> </tr> <tr> <td styleCode="Lrule Toprule"> Confusion</td> <td styleCode="Lrule Toprule">4.9</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">5.7</td> <td styleCode="Lrule Toprule Rrule">7.6</td> </tr> <tr> <td styleCode="Lrule Toprule"> Decreased Concentration</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">2.1</td> <td styleCode="Lrule Toprule">1.3</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Disorientation</td> <td styleCode="Lrule Toprule">2.1</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Dizziness/Lightheadedness</td> <td styleCode="Lrule Toprule">19.7</td> <td styleCode="Lrule Toprule">5.3</td> <td styleCode="Lrule Toprule">28.0</td> <td styleCode="Lrule Toprule Rrule">15.2</td> </tr> <tr> <td styleCode="Lrule Toprule"> Drowsiness</td> <td styleCode="Lrule Toprule">23.9</td> <td styleCode="Lrule Toprule">6.3</td> <td styleCode="Lrule Toprule">40.8</td> <td styleCode="Lrule Toprule Rrule">19.6</td> </tr> <tr> <td styleCode="Lrule Toprule"> Excitement</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">5.1</td> <td styleCode="Lrule Toprule Rrule">5.7</td> </tr> <tr> <td styleCode="Lrule Toprule"> Fatigue</td> <td styleCode="Lrule Toprule">11.3</td> <td styleCode="Lrule Toprule">4.2</td> <td styleCode="Lrule Toprule">5.7</td> <td styleCode="Lrule Toprule Rrule">2.5</td> </tr> <tr> <td styleCode="Lrule Toprule"> Headache</td> <td styleCode="Lrule Toprule">9.9</td> <td styleCode="Lrule Toprule">5.3</td> <td styleCode="Lrule Toprule">19.8</td> <td styleCode="Lrule Toprule Rrule">15.8</td> </tr> <tr> <td styleCode="Lrule Toprule"> Insomnia</td> <td styleCode="Lrule Toprule">9.9</td> <td styleCode="Lrule Toprule">10.5</td> <td styleCode="Lrule Toprule">6.4</td> <td styleCode="Lrule Toprule Rrule">12.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Impaired Memory</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule"> Nervousness</td> <td styleCode="Lrule Toprule">14.8</td> <td styleCode="Lrule Toprule">10.5</td> <td styleCode="Lrule Toprule">6.4</td> <td styleCode="Lrule Toprule Rrule">8.2</td> </tr> <tr> <td styleCode="Lrule Toprule">Gastrointestinal</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Abdominal/Gastric Disorder</td> <td styleCode="Lrule Toprule">3.5</td> <td styleCode="Lrule Toprule">4.2</td> <td styleCode="Lrule Toprule">5.7</td> <td styleCode="Lrule Toprule Rrule">4.4</td> </tr> <tr> <td styleCode="Lrule Toprule"> Bad Taste in Mouth</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Diarrhea</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">4.5</td> <td styleCode="Lrule Toprule Rrule">1.9</td> </tr> <tr> <td styleCode="Lrule Toprule"> Nausea/Vomiting</td> <td styleCode="Lrule Toprule">9.9</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">12.7</td> <td styleCode="Lrule Toprule Rrule">9.5</td> </tr> <tr> <td styleCode="Lrule Toprule">Musculoskeletal</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Musculoskeletal Aches/Pains</td> <td styleCode="Lrule Toprule">5.6</td> <td styleCode="Lrule Toprule">3.2</td> <td styleCode="Lrule Toprule">5.1</td> <td styleCode="Lrule Toprule Rrule">2.5</td> </tr> <tr> <td styleCode="Lrule Toprule">Neurological</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Incoordination</td> <td styleCode="Lrule Toprule">4.9</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">1.9</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Paresthesia</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule"> Tremors</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">5.1</td> <td styleCode="Lrule Toprule Rrule">3.8</td> </tr> <tr> <td styleCode="Lrule Toprule">Sexual Function</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Decreased Libido</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">1.3</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule">Other</td> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule"/> <td styleCode="Toprule Rrule"/> </tr> <tr> <td styleCode="Lrule Toprule"> Decreased Appetite</td> <td styleCode="Lrule Toprule">3.5</td> <td styleCode="Lrule Toprule">5.3</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule"> Eyes Red/Tired/Itching</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Head Full-Heavy</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Malaise</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">0.0</td> </tr> <tr> <td styleCode="Lrule Toprule"> Nasal/Sinus Congestion</td> <td styleCode="Lrule Toprule">2.8</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">5.7</td> <td styleCode="Lrule Toprule Rrule">3.2</td> </tr> <tr> <td styleCode="Lrule Toprule"> Nightmares/Vivid Dreams</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">5.1</td> <td styleCode="Lrule Toprule Rrule">5.7</td> </tr> <tr> <td styleCode="Lrule Toprule"> Sweating/Clamminess</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">1.1</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule"> Tinnitus</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule Rrule">*</td> </tr> <tr> <td styleCode="Lrule Toprule"> Weight Gain</td> <td styleCode="Lrule Toprule">1.4</td> <td styleCode="Lrule Toprule">0.0</td> <td styleCode="Lrule Toprule">4.5</td> <td styleCode="Lrule Toprule Rrule">1.9</td> </tr> <tr> <td styleCode="Lrule Toprule"> Weight Loss</td> <td styleCode="Lrule Toprule">*</td> <td styleCode="Lrule Toprule">3.2</td> <td styleCode="Lrule Toprule">5.7</td> <td styleCode="Lrule Toprule Rrule">2.5</td> </tr> </tbody> </table>