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warnings and cautions 5 WARNINGS AND PRECAUTIONS Excessive administration of vitamin D compounds, including paricalcitol capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. • Hypercalcemia: Excessive administration of paricalcitol capsules can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Prescription-based doses of vitamin D and its derivatives should be withheld during paricalcitol treatment ( 5.1 ). • Digitalis toxicity: Potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds ( 5.2 ). • Laboratory tests: Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment. Paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR) ( 5.3 ). • Aluminum overload and toxicity: Avoid excessive use of aluminum containing compounds ( 5.4 ). 5.1 Hypercalcemia Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention [ see Overdosage ( 10 ) ]. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Concomitant administration of high doses of calcium-containing preparations or thiazide diuretics with paricalcitol may increase the risk of hypercalcemia. High intake of calcium and phosphate concomitant with vitamin D compounds may lead to serum abnormalities requiring more frequent patient monitoring and individualized dose titration. Patients also should be informed about the symptoms of elevated calcium, which include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss. Prescription-based doses of vitamin D and its derivatives should be withheld during paricalcitol treatment to avoid hypercalcemia. 5.2 Digitalis Toxicity Digitalis toxicity is potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds. 5.3 Laboratory Tests During the initial dosing or following any dose adjustment of medication, serum calcium, serum phosphorus, and serum or plasma iPTH should be monitored at least every two weeks for 3 months, then monthly for 3 months, and every 3 months thereafter. In pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR). Similar effects have also been seen with calcitriol . 5.4 Aluminum Overload and Toxicity Aluminum-containing preparations (e.g., antacids, phosphate binders) should not be administered chronically with paricalcitol, as increased blood levels of aluminum and aluminum bone toxicity may occur.
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adverse reactions 6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reactions (> 5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults The safety of paricalcitol capsules has been evaluated in three 24 week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of paricalcitol capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3 : Table 3. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol-Treated Group of Three, Double-Blind, Placebo-Controlled CKD Stages 3 and 4 Studies Number (%) of Subjects Adverse Event Includes only events more common in the paricalcitol treatment group. Paricalcitol Capsules (n = 107) Placebo (n = 113) Overall 88 (82%) 86 (76%) Ear and Labyrinth Disorders Vertigo 5 (5%) 0 (0%) Gastrointestinal Disorders Abdominal Discomfort 4 (4%) 1 (1%) Constipation 4 (4%) 4 (4%) Diarrhea 7 (7%) 5 (4%) Nausea 6 (6%) 4 (4%) Vomiting 5 (5%) 5 (4%) General Disorders and Administration Site Conditions Chest Pain 3 (3%) 1 (1%) Edema 6 (6%) 5 (4%) Pain 4 (4%) 4 (4%) Immune System Disorders Hypersensitivity 6 (6%) 2 (2%) Infections and Infestations Fungal Infection 3 (3%) 0 (0%) Gastroenteritis 3 (3%) 3 (3%) Infection 3 (3%) 3 (3%) Sinusitis 3 (3%) 1 (1%) Urinary Tract Infection 3 (3%) 1 (1%) Viral Infection 8 (7%) 8 (7%) Metabolism and Nutrition Disorders Dehydration 3 (3%) 1 (1%) Musculoskeletal and Connective Tissue Disorders Arthritis 5 (5%) 0 (0%) Back Pain 3 (3%) 1 (1%) Muscle Spasms 3 (3%) 0 (0%) Nervous System Disorders Dizziness 5 (5%) 5 (4%) Headache 5 (5%) 5 (4%) Syncope 3 (3%) 1 (1%) Psychiatric Disorders Depression 3 (3%) 0 (0%) Respiratory, Thoracic and Mediastinal Disorders Cough 3 (3%) 2 (2%) Oropharyngeal Pain 4 (4%) 0 (0%) Skin and Subcutaneous Tissue Disorders Pruritus 3 (3%) 3 (3%) Rash 4 (4%) 1 (1%) Skin Ulcer 3 (3%) 0 (0%) Vascular Disorders Hypertension 7 (7%) 4 (4%) Hypotension 5 (5%) 3 (3%) Additional Adverse Reactions The following additional adverse reactions occurred in < 2% of the paricalcitol-treated adult patients in the above double-blind, placebo-controlled clinical trial. Gastrointestinal Disorders: Dry mouth Investigations: Hepatic enzyme abnormal Nervous System Disorders: Dysgeusia Skin and Subcutaneous Tissue Disorders: Urticaria Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. CKD Stage 5 Adults The safety of paricalcitol capsules has been evaluated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received paricalcitol capsules and 27 patients received placebo. The proportion of patients who terminated prematurely from the study due to adverse events was 7% for paricalcitol capsules treated patients and 7% for placebo patients. Adverse events occurring in the paricalcitol capsules group at a frequency of 2% or greater and more frequently than in the placebo group are as follows: Table 5. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol-Treated Group, Double-Blind, Placebo-Controlled CKD Stage 5 Study Number (%) of Subjects Adverse Events Includes only events more common in the paricalcitol treatment group. Paricalcitol Capsules (n = 61) Placebo (n = 27) Overall 43 (70%) 19 (70%) Gastrointestinal Disorders Constipation 3 (5%) 0 (0%) Diarrhea 7 (11%) 3 (11%) Vomiting 4 (7%) 0 (0%) General Disorders and Administration Site Conditions Fatigue 2 (3%) 0 (0%) Edema Peripheral 2 (3%) 0 (0%) Infections and Infestations Nasopharyngitis 5 (8%) 2 (7%) Peritonitis 3 (5%) 0 (0%) Sinusitis 2 (3%) 0 (0%) Urinary Tract Infection 2 (3%) 0 (0%) Metabolism and Nutrition Disorders Fluid Overload 3 (5%) 0 (0%) Hypoglycemia 2 (3%) 0 (0%) Nervous System Disorders Dizziness 4 (7%) 0 (0%) Headache 2 (3%) 0 (0%) Psychiatric Disorders Anxiety 2 (3%) 0 (0%) Insomnia 3 (5%) 0 (0%) Renal and Urinary Disorders Renal Failure Chronic 2 (3%) 0 (0%) Additional Adverse Reactions The following adverse reactions occurred in < 2% of the paricalcitol-treated patients in the above double-blind, placebo-controlled clinical trial. Gastrointestinal Disorders: Gastroesophageal reflux disease Metabolism and Nutrition Disorders: Decreased appetite, hypercalcemia, hypocalcemia Reproductive System and Breast Disorders: Breast tenderness Skin and Subcutaneous Tissue Disorders: Acne Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of paricalcitol capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Angioedema (including laryngeal edema) Investigations: Blood creatinine increased
adverse reactions table <table ID="_RefIDC61121D427FC4AC8A27E38BD60D482C0" width="100%"> <caption>Table 3. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol-Treated Group of Three, Double-Blind, Placebo-Controlled CKD Stages 3 and 4 Studies </caption> <col width="56%"/> <col width="8%"/> <col width="15%"/> <col width="5%"/> <col width="9%"/> <tbody> <tr> <td styleCode="Botrule Lrule Toprule " valign="top"/> <td align="center" colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Number (%) of Subjects</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Adverse Event</content> <footnote ID="_RefIDE9F9B1DBB64A483DBE2BDB49CF9E0E4C">Includes only events more common in the paricalcitol treatment group.</footnote> </paragraph> </td> <td align="center" colspan="2" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Paricalcitol Capsules</content> </paragraph> <paragraph> <content styleCode="bold">(n = 107)</content> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo </content> </paragraph> <paragraph> <content styleCode="bold">(n = 113)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Overall</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">88</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">(82%)</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">86</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">(76%)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Ear and Labyrinth Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Vertigo</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Gastrointestinal Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Abdominal Discomfort</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Constipation</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Diarrhea</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>7</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Nausea</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>6</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(6%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4 </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Vomiting</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">General Disorders and Administration Site Conditions</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Chest Pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Edema</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>6</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(6%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Immune System Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Hypersensitivity</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>6</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(6%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(2%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Infections and Infestations</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Fungal Infection</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Gastroenteritis</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Infection</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Sinusitis</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Urinary Tract Infection</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Viral Infection</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>8</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>8</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Metabolism and Nutrition Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Dehydration</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Musculoskeletal and Connective Tissue Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Arthritis</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Back Pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Muscle Spasms</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Nervous System Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Dizziness</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Headache</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Syncope</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Psychiatric Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Depression</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Respiratory, Thoracic and Mediastinal Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Cough</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(2%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Oropharyngeal Pain</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Skin and Subcutaneous Tissue Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Pruritus</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Rash</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>1</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(1%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Skin Ulcer</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Vascular Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Hypertension</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>7</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(4%)</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule " valign="top"> <paragraph> Hypotension</paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>(3%)</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table ID="_RefID30B9356C314642B095653F7DC60D01DF" width="100%"> <caption>Table 5. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol-Treated Group, Double-Blind, Placebo-Controlled CKD Stage 5 Study </caption> <col width="56%"/> <col width="8%"/> <col width="15%"/> <col width="5%"/> <col width="9%"/> <tbody> <tr> <td styleCode="Botrule Lrule Toprule " valign="top"/> <td align="center" colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Number (%) of Subjects</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Adverse Events</content> <footnote ID="_Ref399848983">Includes only events more common in the paricalcitol treatment group.</footnote> </paragraph> </td> <td align="center" colspan="2" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Paricalcitol Capsules</content> </paragraph> <paragraph> <content styleCode="bold">(n = 61)</content> </paragraph> </td> <td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(n = 27)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Overall </content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">43</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">(70%)</content> </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">19</content> </paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">(70%)</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Gastrointestinal Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Constipation </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Diarrhea </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>7</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(11%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(11%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Vomiting </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">General Disorders and Administration Site Conditions</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Fatigue </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Edema Peripheral </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Infections and Infestations</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Nasopharyngitis </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>5</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(8%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Peritonitis </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Sinusitis </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Urinary Tract Infection </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Metabolism and Nutrition Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Fluid Overload </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Hypoglycemia </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Nervous System Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Dizziness </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>4</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(7%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Headache </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Psychiatric Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Anxiety </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> Insomnia </paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>3</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>(5%)</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Renal and Urinary Disorders</content> </paragraph> </td> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Botrule Lrule " valign="top"> <paragraph> Renal Failure Chronic </paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>2</paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>(3%)</paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>0</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>(0%)</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.