FDA label 30243d03-9f95-4c8e-903a-e68172db08c0

WARNINGS Serious Rash, including Stevens-Johnson Syndrome Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil. Modafinil is not approved for use in pediatric patients for any indication. In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). The median time to rash that resulted in discontinuation was 13 days. No such cases were observed among 380 pediatric patients who received placebo. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience. The reporting rate of TEN and SJS associated with modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate. Estimates of the background incidence rate for these serious skin reactions in the general population range between 1 to 2 cases per million-person years. There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes also occur with modafinil, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, modafinil should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring. Angioedema and Anaphylactoid Reactions One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm), were observed among 1,595 patients treated with armodafinil, the R enantiomer of modafinil (which is the racemic mixture). No such cases were observed in modafinil clinical trials. However, angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness). Multi-organ Hypersensitivity Reactions Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4-33) to the initiation of modafinil. Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, hematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia. Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur. If a multi-organ hypersensitivity reaction is suspected, PROVIGIL should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility. Persistent Sleepiness Patients with abnormal levels of sleepiness who take PROVIGIL should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking PROVIGIL, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity. Prescribers should also be aware that patients may not acknowledge sleepiness or drowsiness until directly questioned about drowsiness or sleepiness during specific activities. Psychiatric Symptoms Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history. One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily 600 mg doses of modafinil and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation. In the adult modafinil controlled trials database, psychiatric symptoms resulting in treatment discontinuation (at a frequency ≥0.3%) and reported more often in patients treated with modafinil compared to those treated with placebo were anxiety (1%), nervousness (1%), insomnia (<1%), confusion (<1%), agitation (<1%), and depression (<1%). Caution should be exercised when PROVIGIL is given to patients with a history of psychosis, depression, or mania. Consideration should be given to the possible emergence or exacerbation of psychiatric symptoms in patients treated with PROVIGIL. If psychiatric symptoms develop in association with PROVIGIL administration, consider discontinuing PROVIGIL.

ADVERSE REACTIONS Modafinil has been evaluated for safety in over 3500 patients, of whom more than 2000 patients with excessive sleepiness associated with primary disorders of sleep and wakefulness were given at least one dose of modafinil. In clinical trials, modafinil has been found to be generally well tolerated and most adverse experiences were mild to moderate. The most commonly observed adverse events (≥5%) associated with the use of PROVIGIL more frequently than placebo-treated patients in the placebo-controlled clinical studies in primary disorders of sleep and wakefulness were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse event profile was similar across these studies. In the placebo-controlled clinical trials, 74 of the 934 patients (8%) who received PROVIGIL discontinued due to an adverse experience compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for PROVIGIL than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain and nervousness (each <1%). In a Canadian clinical trial, a 35 year old obese narcoleptic male with a prior history of syncopal episodes experienced a 9-second episode of asystole after 27 days of modafinil treatment (300 mg/day in divided doses). Incidence in Controlled Trials The following table (Table 3) presents the adverse experiences that occurred at a rate of 1% or more and were more frequent in adult patients treated with PROVIGIL than in placebo-treated patients in the principal, placebo-controlled clinical trials. The prescriber should be aware that the figures provided below cannot be used to predict the frequency of adverse experiences in the course of usual medical practice, where patient characteristics and other factors may differ from those occurring during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. Review of these frequencies, however, provides prescribers with a basis to estimate the relative contribution of drug and non-drug factors to the incidence of adverse events in the population studied. Table 3. Incidence Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trials 1 With PROVIGIL In Adults With Narcolepsy, OSA, and SWD (200mg, 300mg and 400mg)* Body System Preferred Term Modafinil (n = 934) Placebo (n = 567) * Six double-blind, placebo-controlled clinical studies in narcolepsy, OSA, and SWD. 1 Events reported by at least 1% of patients treated with PROVIGIL that were more frequent than in the placebo group are included; incidence is rounded to the nearest 1%. The adverse experience terminology is coded using a standard modified COSTART Dictionary. Events for which the PROVIGIL incidence was at least 1%, but equal to or less than placebo are not listed in the table. These events included the following: infection, pain, accidental injury, abdominal pain, hypothermia, allergic reaction, asthenia, fever, viral infection, neck pain, migraine, abnormal electrocardiogram, hypotension, tooth disorder, vomiting, periodontal abscess, increased appetite, ecchymosis, hyperglycemia, peripheral edema, weight loss, weight gain, myalgia, leg cramps, arthritis, cataplexy, thinking abnormality, sleep disorder, increased cough, sinusitis, dyspnea, bronchitis, rash, conjunctivitis, ear pain, dysmenorrhea 4 , urinary tract infection. 2 Elevated liver enzymes. 3 Oro-facial dyskinesias. 4 Incidence adjusted for gender. Body as a Whole Headache 34% 23% Back Pain 6% 5% Flu Syndrome 4% 3% Chest Pain 3% 1% Chills 1% 0% Neck Rigidity 1% 0% Cardiovascular Hypertension 3% 1% Tachycardia 2% 1% Palpitation 2% 1% Vasodilatation 2% 0% Digestive Nausea 11% 3% Diarrhea 6% 5% Dyspepsia 5% 4% Dry Mouth 4% 2% Anorexia 4% 1% Constipation 2% 1% Abnormal Liver Function 2 2% 1% Flatulence 1% 0% Mouth Ulceration 1% 0% Thirst 1% 0% Hemic/Lymphatic Eosinophilia 1% 0% Metabolic/Nutritional Edema 1% 0% Nervous Nervousness 7% 3% Insomnia 5% 1% Anxiety 5% 1% Dizziness 5% 4% Depression 2% 1% Paresthesia 2% 0% Somnolence 2% 1% Hypertonia 1% 0% Dyskinesia 3 1% 0% Hyperkinesia 1% 0% Agitation 1% 0% Confusion 1% 0% Tremor 1% 0% Emotional Lability 1% 0% Vertigo 1% 0% Respiratory Rhinitis 7% 6% Pharyngitis 4% 2% Lung Disorder 2% 1% Epistaxis 1% 0% Asthma 1% 0% Skin/Appendages Sweating 1% 0% Herpes Simplex 1% 0% Special Senses Amblyopia 1% 0% Abnormal Vision 1% 0% Taste Perversion 1% 0% Eye Pain 1% 0% Urogenital Urine Abnormality 1% 0% Hematuria 1% 0% Pyuria 1% 0% Dose Dependency of Adverse Events In the adult placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of PROVIGIL and placebo, the only adverse events that were clearly dose related were headache and anxiety. Vital Sign Changes While there was no consistent change in mean values of heart rate or systolic and diastolic blood pressure, the requirement for antihypertensive medication was slightly greater in patients on PROVIGIL compared to placebo (See PRECAUTIONS ). Weight Changes There were no clinically significant differences in body weight change in patients treated with PROVIGIL compared to placebo-treated patients in the placebo-controlled clinical trials. Laboratory Changes Clinical chemistry, hematology, and urinalysis parameters were monitored in Phase 1, 2, and 3 studies. In these studies, mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of PROVIGIL, but not placebo. Few subjects, however, had GGT or AP elevations outside of the normal range. Shifts to higher, but not clinically significantly abnormal, GGT and AP values appeared to increase with time in the population treated with PROVIGIL in the Phase 3 clinical trials. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin. ECG Changes No treatment-emergent pattern of ECG abnormalities was found in placebo-controlled clinical trials following administration of PROVIGIL. Postmarketing Reports The following adverse reactions have been identified during post-approval use of PROVIGIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of the reporting, or (3) strength of causal connection to PROVIGIL. Hematologic: agranulocytosis

<table width="0.000" ID="l12a3f493-008d-4059-a1d7-a78a2e016d1c"> <caption ID="id_9fd1e87f-11d7-44ab-b39a-0a48dfdccd1f">Table 3. Incidence Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trials¹ With PROVIGIL In Adults With Narcolepsy, OSA, and SWD (200mg, 300mg and 400mg)*</caption> <col/> <col/> <col/> <col/> <thead> <tr ID="id_fa02568c-1e7c-43c9-a731-7ab94343463f" styleCode="Botrule"> <td align="left" valign="top"> <content styleCode="bold">Body System</content> </td> <td align="left" valign="top"> <content styleCode="bold">Preferred Term</content> </td> <td align="center" valign="top"> <content styleCode="bold">Modafinil</content> <content styleCode="bold">(n = 934)</content> </td> <td align="center" valign="top"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n = 567)</content> </td> </tr> </thead> <tfoot ID="id_9bb59960-9147-49d6-9f21-1c8158e7d92c"> <tr> <td align="left" valign="top" colspan="4"> <paragraph>* Six double-blind, placebo-controlled clinical studies in narcolepsy, OSA, and SWD. </paragraph> <paragraph> ¹ Events reported by at least 1% of patients treated with PROVIGIL that were more frequent than in the placebo group are included; incidence is rounded to the nearest 1%. The adverse experience terminology is coded using a standard modified COSTART Dictionary. </paragraph> <paragraph> </paragraph> <paragraph>Events for which the PROVIGIL incidence was at least 1%, but equal to or less than placebo are not listed in the table. These events included the following: infection, pain, accidental injury, abdominal pain, hypothermia, allergic reaction, asthenia, fever, viral infection, neck pain, migraine, abnormal electrocardiogram, hypotension, tooth disorder, vomiting, periodontal abscess, increased appetite, ecchymosis, hyperglycemia, peripheral edema, weight loss, weight gain, myalgia, leg cramps, arthritis, cataplexy, thinking abnormality, sleep disorder, increased cough, sinusitis, dyspnea, bronchitis, rash, conjunctivitis, ear pain, dysmenorrhea⁴, urinary tract infection.</paragraph> <paragraph> ²Elevated liver enzymes. </paragraph> <paragraph> ³ Oro-facial dyskinesias. </paragraph> <paragraph> ⁴ Incidence adjusted for gender.</paragraph> </td> </tr> </tfoot> <tbody> <tr ID="id_7f1c8094-9e69-4ce8-bc3a-279be5df6332" styleCode="Toprule"> <td align="left" valign="top">Body as a Whole</td> <td align="left" valign="top" styleCode="Toprule">Headache</td> <td align="center" valign="top" styleCode="Toprule">34%</td> <td align="center" valign="top">23%</td> </tr> <tr ID="id_787972a0-8643-42fd-ac2a-9149d892d858"> <td align="left" valign="top"/> <td align="left" valign="top">Back Pain</td> <td align="center" valign="top">6%</td> <td align="center" valign="top">5%</td> </tr> <tr ID="id_17e99668-0dd2-46ac-870d-69678e3514ee"> <td align="left" valign="top"/> <td align="left" valign="top">Flu Syndrome</td> <td align="center" valign="top">4%</td> <td align="center" valign="top">3%</td> </tr> <tr ID="id_baa7944f-48cb-4352-aec0-fd5a9d70b5f6"> <td align="left" valign="top"/> <td align="left" valign="top">Chest Pain</td> <td align="center" valign="top">3%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_e405c36d-386b-488e-a602-680668ce3d9d"> <td align="left" valign="top"/> <td align="left" valign="top">Chills</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_09437006-c973-4efd-b6e6-9c20282d98a3"> <td align="left" valign="top"/> <td align="left" valign="top">Neck Rigidity</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_d70882b2-c0ad-4c65-bf9e-1c11bd9bef38"> <td align="left" valign="top">Cardiovascular</td> <td align="left" valign="top">Hypertension</td> <td align="center" valign="top">3%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_615a2e7e-af99-42a5-b7ba-a9ebf881625a"> <td align="left" valign="top"/> <td align="left" valign="top">Tachycardia</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_ff23cbe3-ac33-4fb5-a57f-31a7ddcc5cd2"> <td align="left" valign="top"/> <td align="left" valign="top">Palpitation</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_98dfcfb8-38af-414f-a373-b2bf08df8f51"> <td align="left" valign="top"/> <td align="left" valign="top">Vasodilatation</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_67001ceb-92bc-4990-b7ac-8a0fc8a4f828"> <td align="left" valign="top">Digestive</td> <td align="left" valign="top">Nausea</td> <td align="center" valign="top">11%</td> <td align="center" valign="top">3%</td> </tr> <tr ID="id_2e5073b3-4c09-4412-af01-1ae8c491d6d6"> <td align="left" valign="top"/> <td align="left" valign="top">Diarrhea</td> <td align="center" valign="top">6%</td> <td align="center" valign="top">5%</td> </tr> <tr ID="id_ddc2fc16-57a0-420c-a236-f8018f14a2b8"> <td align="left" valign="top"/> <td align="left" valign="top">Dyspepsia</td> <td align="center" valign="top">5%</td> <td align="center" valign="top">4%</td> </tr> <tr ID="id_9cbdc002-6ef6-4b6a-9aa6-8fe3c50e9165"> <td align="left" valign="top"/> <td align="left" valign="top">Dry Mouth</td> <td align="center" valign="top">4%</td> <td align="center" valign="top">2%</td> </tr> <tr ID="id_633fdbc5-c2ab-4af6-bc63-e3eb5149efaf"> <td align="left" valign="top"/> <td align="left" valign="top">Anorexia</td> <td align="center" valign="top">4%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_7dae9059-cf15-4aa4-b542-f219ac0dd779"> <td align="left" valign="top"/> <td align="left" valign="top">Constipation</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_23d7d4c1-ed45-44bd-8571-3df977598f21"> <td align="left" valign="top"/> <td align="left" valign="top">Abnormal Liver Function² </td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_027637b2-c703-4afc-a322-44015673c6fb"> <td align="left" valign="top"/> <td align="left" valign="top">Flatulence</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_04380b37-56f5-49e6-b73a-729b47d21623"> <td align="left" valign="top"/> <td align="left" valign="top">Mouth Ulceration</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_a0ff76f3-df35-42b0-867f-68d956724537"> <td align="left" valign="top"/> <td align="left" valign="top">Thirst</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_3ef5c45e-0a81-427a-a0bf-b8ebeb9df330"> <td align="left" valign="top">Hemic/Lymphatic</td> <td align="left" valign="top">Eosinophilia</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_457f601f-509c-4e5a-bf8f-e72d5eedaa3e"> <td align="left" valign="top">Metabolic/Nutritional</td> <td align="left" valign="top">Edema</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_84977ff8-d500-48e7-9536-05baeb677353"> <td align="left" valign="top">Nervous</td> <td align="left" valign="top">Nervousness</td> <td align="center" valign="top">7%</td> <td align="center" valign="top">3%</td> </tr> <tr ID="id_5280b4ca-f2d5-4b7d-a281-0d67cbe9e8dc"> <td align="left" valign="top"/> <td align="left" valign="top">Insomnia</td> <td align="center" valign="top">5%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_53dd39eb-1b9a-4277-a248-e933bae00322"> <td align="left" valign="top"/> <td align="left" valign="top">Anxiety</td> <td align="center" valign="top">5%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_1a974782-ae43-4bec-8e08-60e9cef5540c"> <td align="left" valign="top"/> <td align="left" valign="top">Dizziness</td> <td align="center" valign="top">5%</td> <td align="center" valign="top">4%</td> </tr> <tr ID="id_47186afa-3005-4ea8-bae0-d973b58dcd77"> <td align="left" valign="top"/> <td align="left" valign="top">Depression</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_c0e34674-c63c-482b-b006-b6191c4be2f3"> <td align="left" valign="top"/> <td align="left" valign="top">Paresthesia</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_134d5625-edc8-410b-85d9-d3bdd96f7519"> <td align="left" valign="top"/> <td align="left" valign="top">Somnolence</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_26823afb-b2c0-46e8-a8be-7e71ab9a9df7"> <td align="left" valign="top"/> <td align="left" valign="top">Hypertonia</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_d5925aa7-8473-451c-8b84-450a60788127"> <td align="left" valign="top"/> <td align="left" valign="top">Dyskinesia³ </td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_dc2d03a9-5f22-4d2d-88ba-3a150527d986"> <td align="left" valign="top"/> <td align="left" valign="top">Hyperkinesia</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_fa8330c0-7271-444a-92bf-d41b277f2688"> <td align="left" valign="top"/> <td align="left" valign="top">Agitation</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_d1a087c0-c104-4fce-be4e-009900284f27"> <td align="left" valign="top"/> <td align="left" valign="top">Confusion</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_8051f265-867c-4617-b429-ec9b31f59f8a"> <td align="left" valign="top"/> <td align="left" valign="top">Tremor</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_b1a28def-ddfa-4454-ae18-4bb514891b6b"> <td align="left" valign="top"/> <td align="left" valign="top">Emotional Lability</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_ebbf4a2d-bfaa-477d-b640-530033e2497e"> <td align="left" valign="top"/> <td align="left" valign="top">Vertigo</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_687c28c6-e062-4d52-a8e1-104d612a16a0"> <td align="left" valign="top">Respiratory</td> <td align="left" valign="top">Rhinitis</td> <td align="center" valign="top">7%</td> <td align="center" valign="top">6%</td> </tr> <tr ID="id_b6e0b545-38d3-456f-9e9a-ed42fff9d9ac"> <td align="left" valign="top"/> <td align="left" valign="top">Pharyngitis</td> <td align="center" valign="top">4%</td> <td align="center" valign="top">2%</td> </tr> <tr ID="id_ec42809c-75db-4626-92bf-e17a2aa3b3db"> <td align="left" valign="top"/> <td align="left" valign="top">Lung Disorder</td> <td align="center" valign="top">2%</td> <td align="center" valign="top">1%</td> </tr> <tr ID="id_3f655a77-d830-49b1-9394-03b2012acaff"> <td align="left" valign="top"/> <td align="left" valign="top">Epistaxis</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_8d8301c1-0e9c-4205-a1ec-58449991282b"> <td align="left" valign="top"/> <td align="left" valign="top">Asthma</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_76faf555-1921-4fa2-9a3e-610dfaa0152e"> <td align="left" valign="top">Skin/Appendages</td> <td align="left" valign="top">Sweating</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_8e74c3b2-9094-4a18-9e8c-156eedb85e93"> <td align="left" valign="top"/> <td align="left" valign="top">Herpes Simplex</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_0655868b-214f-4cca-8325-30a63195323c"> <td align="left" valign="top">Special Senses</td> <td align="left" valign="top">Amblyopia</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_89427cd4-3835-4689-a222-a2ae0a6a41c1"> <td align="left" valign="top"/> <td align="left" valign="top">Abnormal Vision</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_7c7262e6-62e4-42a1-bc9a-d034540ad18c"> <td align="left" valign="top"/> <td align="left" valign="top">Taste Perversion</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_d137bfe5-ffc1-4e0c-b496-656aaf89f05d"> <td align="left" valign="top"/> <td align="left" valign="top">Eye Pain</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_9e789b13-0acc-4f05-a990-2ad9be2640cb"> <td align="left" valign="top">Urogenital</td> <td align="left" valign="top">Urine Abnormality</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_1e44d645-30ac-4d10-b205-bf87f51d3335"> <td align="left" valign="top"/> <td align="left" valign="top">Hematuria</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> <tr ID="id_8c61edad-a6ab-42ba-9fa2-1d5b476d8a73"> <td align="left" valign="top"/> <td align="left" valign="top">Pyuria</td> <td align="center" valign="top">1%</td> <td align="center" valign="top">0%</td> </tr> </tbody> </table>