Home FDA labels eb131915-222b-49d9-8e66-cd0f0afd066c Nicardipine Hydrochloride openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Nicardipine Hydrochloride
Generic name NICARDIPINE HYDROCHLORIDE
Manufacturer Glenmark Pharmaceuticals Inc., USA
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 3955d43d-a87f-4d2c-b90e-3ecf0d6aa148
SPL ID eb131915-222b-49d9-8e66-cd0f0afd066c
Version 3
Effective date 2026-01-29
Source export date 2026-10-12
Source partition 13
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warnings WARNINGS Increased Angina About 7% of patients in short-term, placebo-controlled angina trials have developed increased frequency, duration or severity of angina on starting nicardipine hydrochloride or at the time of dosage increases, compared with 4% of patients on placebo. Comparisons with beta-blockers also show a greater frequency of increased angina, 4% vs 1%. The mechanism of this effect has not been established (see ADVERSE REACTIONS ). Use in Patients with Congestive Heart Failure Although preliminary hemodynamic studies in patients with congestive heart failure have shown that nicardipine hydrochloride reduced afterload without impairing myocardial contractility, it has a negative inotropic effect in vitro and in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker. Beta-Blocker Withdrawal Nicardipine hydrochloride is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker, preferably over 8 to 10 days.
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adverse reactions ADVERSE REACTIONS In multiple-dose US and foreign controlled short-term (up to 3 months) studies 1910 patients received nicardipine hydrochloride alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasionally required dosage adjustment and about 10% of patients left the studies prematurely because of them. Peak responses were not observed to be associated with adverse effects during clinical trials, but physicians should be aware that adverse effects associated with decreases in blood pressure (tachycardia, hypotension, etc.) could occur around the time of the peak effect. Most adverse effects were expected consequences of the vasodilator effects of nicardipine hydrochloride. Angina The incidence rates of adverse effects in anginal patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride (n=520) and placebo (n=310), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator (except for certain cardiovascular events that were recorded in a different category). Where the frequency of adverse effects for nicardipine hydrochloride and placebo is similar, causal relationship is uncertain. The only dose-related effects were pedal edema and increased angina. Table 2: Percent of Patients with Adverse Effects in Controlled Studies (Incidence of Discontinuations Shown in Parentheses) Adverse Experience Nicardipine Hydrochloride (n= 520) PLACEBO (n= 310) Pedal Edema 7.1 (0) 0.3 (0) Dizziness 6.9 (1.2) 0.6 (0) Headache 6.4 (0.6) 2.6 (0) Asthenia 5.8 (0.4) 2.6 (0) Flushing 5.6 (0.4) 1 (0) Increased Angina 5.6 (3.5) 4.2 (1.9) Palpitations 3.3 (0.4) 0 (0) Nausea 1.9 (0) 0.3 (0) Dyspepsia 1.5 (0.6) 0.6 (0.3) Dry Mouth 1.4 (0) 0.3 (0) Somnolence 1.4 (0) 1 (0) Rash 1.2 (0.2) 0.3 (0) Tachycardia 1.2 (0.2) 0.6 (0) Myalgia 1 (0) 0 (0) Other Edema 1 (0) 0 (0) Paresthesia 1 (0.2) 0.3 (0) Sustained Tachycardia 0.8 (0.6) 0 (0) Syncope 0.8 (0.2) 0 (0) Constipation 0.6 (0.2) 0.6 (0) Dyspnea 0.6 (0) 0 (0) Abnormal ECG 0.6 (0.6) 0 (0) Malaise 0.6 (0) 0 (0) Nervousness 0.6 (0) 0.3 (0) Tremor 0.6 (0) 0 (0) In addition, adverse events were observed that are not readily distinguishable from the natural history of the atherosclerotic vascular disease in these patients. Adverse events in this category each occurred in <0.4% of patients receiving nicardipine hydrochloride and included myocardial infarction, atrial fibrillation, exertional hypotension, pericarditis, heart block, cerebral ischemia, and ventricular tachycardia. It is possible that some of these events were drug-related. Hypertension The incidence rates of adverse effects in hypertensive patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride (n=1,390) and placebo (n=211), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator. Where the frequency of adverse effects for nicardipine hydrochloride and placebo is similar, causal relationship is uncertain. The only dose-related effect was pedal edema. Table 3: Percent of Patients with Adverse Effects in Controlled Studies (Incidence of discontinuations shown in parentheses) Adverse Experience Nicardipine Hydrochloride (n = 1,390) PLACEBO (n = 211) Flushing 9.7 (2.1) 2.8 (0) Headache 8.2 (2.6) 4.7 (0) Pedal Edema 8 (1.8) 0.9 (0) Asthenia 4.2 (1.7) 0.5 (0) Palpitations 4.1 (1) 0 (0) Dizziness 4 (1.8) 0 (0) Tachycardia 3.4 (1.2) 0.5 (0) Nausea 2.2 (0.9) 0.9 (0) Somnolence 1.1 (0.1) 0 (0) Dyspepsia 0.8 (0.3) 0.5 (0) Insomnia 0.6 (0.1) 0 (0) Malaise 0.6 (0.1) 0 (0) Other Edema 0.6 (0.3) 1.4 (0) Abnormal Dreams 0.4 (0) 0 (0) Dry Mouth 0.4 (0.1) 0 (0) Nocturia 0.4 (0) 0 (0) Rash 0.4 (0.4) 0 (0) Vomiting 0.4 (0.4) 0 (0) Rare Events The following rare adverse events have been reported in clinical trials or the literature: Body as a Whole: infection, allergic reaction Cardiovascular: hypotension, postural hypotension, atypical chest pain, peripheral vascular disorder, ventricular extrasystoles, ventricular tachycardia Digestive: sore throat, abnormal liver chemistries Musculoskeletal: arthralgia Nervous: hot flashes, vertigo, hyperkinesia, impotence, depression, confusion, anxiety Respiratory: rhinitis, sinusitis Special Senses: tinnitus, abnormal vision, blurred vision Urogenital: increased urinary frequency
adverse reactions table <table cellpadding="0pt" width="90.78%"><col width="36%"/><col width="16%"/><col width="13%"/><col width="12%"/><col width="12%"/><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Adverse Experience</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Nicardipine Hydrochloride</content> <content styleCode="bold">(n= 520)</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">PLACEBO</content> <content styleCode="bold">(n= 310)</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Pedal Edema</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>7.1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dizziness</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>6.9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Headache</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>6.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.6)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>2.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Asthenia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5.8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>2.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Flushing</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Increased Angina</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4.2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Palpitations</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>3.3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.4)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dyspepsia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.6)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dry Mouth</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Somnolence</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Rash</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Tachycardia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Myalgia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Other Edema</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Paresthesia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Sustained Tachycardia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.6)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Syncope</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.2)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dyspnea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Abnormal ECG</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.6)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Malaise</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Nervousness</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Tremor</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(0)</paragraph></td></tr></tbody></table>
adverse reactions table <table cellpadding="0pt" width="92.14%"><col width="37%"/><col width="16%"/><col width="14%"/><col width="13%"/><col width="11%"/><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Adverse Experience</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Nicardipine Hydrochloride</content> <content styleCode="bold">(n = 1,390)</content></th><th align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">PLACEBO</content> <content styleCode="bold">(n = 211)</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Flushing</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>9.7</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(2.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>2.8</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Headache</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8.2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(2.6)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4.7</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Pedal Edema</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Asthenia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4.2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Palpitations</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4.1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Dizziness</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.8)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Tachycardia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>3.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>2.2</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.9)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Somnolence</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.1</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.1)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Dyspepsia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Insomnia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.1)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Malaise</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.1)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Other Edema</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Abnormal Dreams</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Dry Mouth</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.1)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Nocturia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Lrule Botrule " valign="top"><paragraph>Rash</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>0.4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(0.4)</paragraph></td><td align="center" styleCode="Rrule 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="Rrule Botrule Lrule " valign="top"><paragraph>Vomiting</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>0.4</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(0.4)</paragraph></td><td align="center" styleCode="Rrule 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.