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FDA label 90a822ca-dfce-49e2-92c8-e8f41ebe83ed
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- c5745462-fab9-4916-acee-1bc6f9e63560
- SPL ID
- 90a822ca-dfce-49e2-92c8-e8f41ebe83ed
- Version
- 3
- Effective date
- 2012-08-06
- Source export date
- 2026-08-01
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:08:52
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 90a822ca-dfce-49e2-92c8-e8f41ebe83ed | id | |
| spl set id | c5745462-fab9-4916-acee-1bc6f9e63560 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In a controlled clinical trial with DYNACIRC CR, dose-related edema occurred at an incidence of approximately 9% at 5 mg, 13% at 10 mg, 16% at 15 mg, and 36% at the highest dose studied (20 mg); was mild to moderate in severity; and was not related to age or gender. The incidences of elicited or volunteered adverse reactions (excluding non-drug related) in the following tables are based on 6-week multicenter, placebo-controlled, double-blind hypertension studies. Less than 1% of patients treated with DYNACIRC CR or placebo discontinued from these studies due to adverse reactions. The most common adverse experiences (≥1.0%) reported with DYNACIRC CR in a dose-response study are shown in the following table. There were no discontinuations of patients treated with DYNACIRC CR in this study due to these common side effects. Most Frequently Reported Newly-Occurring Adverse Reactions in Dose-Response Study DYNACIRC CR Placebo Group Adverse Reactions (Excluding Non-Drug Related) 5 mg (N=79) 10mg (N=79) 15mg (N=82) 20 mg (N=78) (N=83) Headache 13.9% 12.7% 18.3% 10.3% 15.7% Edema 8.9% 12.7% 15.9% 35.9% 3.6% Dizziness 5.1% 6.3% 3.7% 6.4% 2.4% Constipation 3.8% 1.3% 1.2% 2.6% 0.0% Fatigue 2.5% 7.6% 3.7% 3.8% 2.4% Flushing 2.5% 3.8% 1.2% 1.3% 1.2% Abdominal discomfort 1.3% 5.1% 3.7% 5.1% 1.2% Rash 1.3% 1.3% 0.0% 2.6% 0.0% The table below shows elicited or volunteered adverse experiences for patients treated with DYNACIRC CR in two 6-week, placebo-controlled, multicenter studies, at doses from 5 to 20 mg, and considered by the investigator to be at least possibly drug related. The results for patients treated with DYNACIRC CR are presented for all doses pooled together (reported by at least 1.0% of active drug-treated patients). The incidence of adverse reactions is listed below: Treatment Group Adverse Reactions (Excluding Non-Drug Related) DYNACIRC CR (N=422) Placebo (N=186) Edema 15.2% 2.2% Headache 13.0% 12.4% Dizziness 4.7% 2.7% Fatigue 4.3% 2.2% Abdominal discomfort 2.8% 0.5% Flushing 1.9% 0.5% Constipation 1.7% 0.0% Palpitations 1.2% 0.0% Nausea 1.2% 1.6% Abdominal distention 1.2% 0.0% The following adverse experiences were reported in 0.5% to 1.0% or less of patients treated with DYNACIRC CR or immediate-release DYNACIRC in hypertensive studies, or were noted in postmarketing experience with immediate-release DYNACIRC. More serious events are shown in italics. The relationship of these adverse experiences to isradipine administration is uncertain. Skin Pruritus, urticaria , angioedema . Musculoskeletal Backache/pain, joint pain, neck pain/sore/stiff, legs ache/pain, cramps of legs/feet. Respiratory Dyspnea, nasal congestion, cough. Cardiovascular Epistaxis, tachycardia, chest pain, shortness of breath, hypotension, syncope, atrial or ventricular fibrillation, myocardial infarction, heart failure. Gastrointestinal Diarrhea, vomiting, appetite increased or decreased. Urogenital Pollakiuria, impotence, dysuria, nocturia. Central Nervous Drowsiness, insomnia, lethargy, nervousness, libido decrease/frigidity, impotence, depression, paresthesia (which includes numbness and tingling), transient ischemic attack, stroke. Autonomic Dry mouth, hyperhidrosis, visual disturbance. Miscellaneous Weight gain, throat discomfort, drug fever, leukopenia , elevated liver function tests. No gastrointestinal bleeding has been reported in clinical trials with DYNACIRC CR Controlled Release Tablets. In a long-term (one-year) open-label, hypertension trial with DYNACIRC CR, the adverse events reported were generally the same as those seen in the short-term placebo-controlled studies. About 6% of patients treated with DYNACIRC CR discontinued the long-term trial due to adverse reactions. With immediate-release DYNACIRC, most of the adverse experiences were transient, mild, and related to vasodilatory effects. The following table shows the most common adverse events reported in US clinical trials for immediate-release DYNACIRC, volunteered or elicited, and considered by the investigator to be at least possibly drug related. DYNACIRC Placebo Active Controls * Adverse Experience All Doses 2.5 mg twice-daily 5 mg twice-daily † 10 mg twice-daily †† (N=297) % (N=414) % Headache 13.7 12.6 10.7 22.0 14.1 9.4 Dizziness 7.3 8.0 5.3 3.4 4.4 8.2 Edema 7.2 3.5 8.7 8.5 3.0 2.9 Palpitations 4.0 1.0 4.7 5.1 1.4 1.5 Fatigue 3.9 2.5 2.0 8.5 0.3 6.3 Flushing 2.6 3.0 2.0 5.1 0.0 1.2 Chest pain 2.4 2.5 2.7 1.7 2.4 2.9 Nausea 1.8 1.0 2.7 5.1 1.7 3.1 Dyspnea 1.8 0.5 2.7 3.4 1.0 2.2 Abdominal discomfort 1.7 0.0 3.3 1.7 1.7 3.9 Tachycardia 1.5 1.0 1.3 3.4 0.3 0.5 Rash 1.5 1.5 2.0 1.7 0.3 0.7 Pollakiuria 1.5 2.0 1.3 3.4 0.0 <1.0 Weakness 1.2 0.0 0.7 0.0 0.0 1.2 Vomiting 1.1 1.0 1.3 0.0 0.3 0.2 Diarrhea 1.1 0.0 2.7 3.4 2.0 1.9 * Propranolol, prazosin, hydrochlorothiazide, enalapril, and captopril. † Initial dose of 2.5 mg twice-daily followed by maintenance dose of 5.0 mg twice-daily. †† Initial dose of 2.5 mg twice-daily followed by sequential titration to 5.0 mg twice-daily, 7.5 mg twice-daily, and maintenance dose of 10.0 mg twice-daily. In open-label, long-term studies of up to 2 years in duration with immediate-release DYNACIRC, the adverse experiences reported were generally the same as those reported in the short-term controlled trials. The overall frequencies of these adverse events were slightly higher in the long-term than in the controlled studies, but in the controlled studies most adverse reactions were mild and transient.
adverse reactions table
<table ID="_Refid_a0f06f7e-99a2-44b6-8bfd-868f0ad0a"> <caption>Most Frequently Reported Newly-Occurring Adverse Reactions in Dose-Response Study</caption> <col width="23%"/> <col width="9%"/> <col width="9%"/> <col width="9%"/> <col width="9%"/> <col width="17%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule "/> <td align="center" colspan="4" styleCode="Rrule Botrule Toprule "> <paragraph> <content styleCode="bold">DYNACIRC CR</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule "> <paragraph> <content styleCode="bold">Placebo Group</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph> <content styleCode="bold">Adverse Reactions</content> </paragraph> <paragraph> <content styleCode="bold">(Excluding </content> </paragraph> <paragraph> <content styleCode="bold">Non-Drug Related)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">5 mg</content> </paragraph> <paragraph> <content styleCode="bold">(N=79)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">10mg</content> </paragraph> <paragraph> <content styleCode="bold">(N=79)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">15mg</content> </paragraph> <paragraph> <content styleCode="bold">(N=82)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">20 mg</content> </paragraph> <paragraph> <content styleCode="bold">(N=78)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">(N=83)</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>13.9%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>12.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>18.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>10.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>15.7%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Edema</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>8.9%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>12.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>15.9%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>35.9%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.6%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Dizziness</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.1%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>6.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>6.4%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.4%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Constipation</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.8%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.6%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Fatigue</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.5%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>7.6%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.8%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.4%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Flushing</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.5%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.8%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Abdominal discomfort</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.1%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.1%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule "> <paragraph>Rash</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.6%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0%</paragraph> </td> </tr> </tbody> </table>
adverse reactions table
<table> <col width="33%"/> <col width="19%"/> <col width="10%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule "/> <td align="center" colspan="2" styleCode="Rrule Botrule Toprule "> <paragraph> <content styleCode="bold">Treatment Group</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph> <content styleCode="bold">Adverse Reactions</content> </paragraph> <paragraph> <content styleCode="bold">(Excluding Non-Drug Related)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">DYNACIRC CR</content> </paragraph> <paragraph> <content styleCode="bold">(N=422)</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(N=186)</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Edema</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>15.2%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.2%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>13.0%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>12.4%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Dizziness</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>4.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.7%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Fatigue</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>4.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.2%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Abdominal discomfort</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.8%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.5%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Flushing</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.9%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.5%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Constipation</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Palpitations</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Nausea</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.6%</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule "> <paragraph>Abdominal distention</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2%</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0%</paragraph> </td> </tr> </tbody> </table>
adverse reactions table
<table> <col width="23%"/> <col width="8%"/> <col width="13%"/> <col width="14%"/> <col width="14%"/> <col width="10%"/> <col width="12%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule "/> <td align="center" colspan="4" styleCode="Rrule Botrule Toprule "> <paragraph> <content styleCode="bold">DYNACIRC</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule "> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule "> <paragraph> <content styleCode="bold">Active</content> </paragraph> <paragraph> <content styleCode="bold">Controls<sup>*</sup> </content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph> <content styleCode="bold">Adverse </content> </paragraph> <paragraph> <content styleCode="bold">Experience</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">All</content> </paragraph> <paragraph> <content styleCode="bold">Doses</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">2.5 mg</content> </paragraph> <paragraph> <content styleCode="bold">twice-daily</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">5 mg</content> </paragraph> <paragraph> <content styleCode="bold">twice-daily<sup>†</sup> </content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">10 mg</content> <content styleCode="bold">twice-daily<sup>††</sup> </content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">(N=297)</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph> <content styleCode="bold">(N=414)</content> </paragraph> <paragraph> <content styleCode="bold">%</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>13.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>12.6</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>10.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>22.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>14.1</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>9.4</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Dizziness</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>7.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>8.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>4.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>8.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Edema</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>7.2</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>8.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>8.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Palpitations</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>4.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>4.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.1</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.5</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Fatigue</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.9</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>8.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>6.3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Flushing</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.6</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.1</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Chest pain</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Nausea</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.8</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>5.1</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.1</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Dyspnea</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.8</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Abdominal discomfort</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Tachycardia</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.5</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Rash</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.7</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Pollakiuria</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.5</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph><1.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Weakness</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule "> <paragraph>Vomiting</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.1</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.3</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.2</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule "> <paragraph>Diarrhea</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.1</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>0.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.7</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>3.4</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>2.0</paragraph> </td> <td align="center" styleCode="Rrule Botrule "> <paragraph>1.9</paragraph> </td> </tr> </tbody> </table>