Isradipine

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 (canonical bytes are SHA-256 checked before publication)

Brand name
Isradipine
Generic name
ISRADIPINE
Manufacturer
Elite Laboratories, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
acf7c376-6cb6-4857-b455-0bf5da29346c
SPL ID
194819ab-8bf2-4f80-b9bb-a1209af1ba21
Version
2
Effective date
2019-12-27
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:56:24
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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warnings

WARNINGS None

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS In multiple dose U.S. studies in hypertension, 1228 patients received isradipine alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents. An additional 652 patients (which includes 374 normal volunteers) received isradipine in U.S. studies of conditions other than hypertension, and 1321 patients received isradipine in non-U.S. studies. About 500 patients received isradipine in long-term hypertension studies, 410 of them for at least 6 months. The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to isradipine, including foreign marketing experience. Most adverse reactions were mild and related to the vasodilatory effects of isradipine (dizziness, edema, palpitations, flushing, tachycardia), and many were transient. About 5% of isradipine patients left studies prematurely because of adverse reactions (vs. 3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances. The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related. The results for the isradipine treated patients are presented for all doses pooled together (reported by 1% or greater of patients receiving any dose of isradipine), and also for the two treatment regimens most applicable to the treatment of hypertension with isradipine: (1) initial and maintenance dose of 2.5 mg b.i.d., and (2) initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5 mg b.i.d. Isradipine All Doses N=934 2.5 mg b.i.d. 199 5 mg b.i.d. † 150 10 mg b.i.d. †† 59 Placebo 297 Active Controls * 414 Adverse Experience % % % % % % Headache 13.7 12.6 10.7 22 14.1 9.4 Dizziness 7.3 8 5.3 3.4 4.4 8.2 Edema 7.2 3.5 8.7 8.5 3 2.9 Palpitations 4 1 4.7 5.1 1.4 1.5 Fatigue 3.9 2.5 2 8.5 0.3 6.3 Flushing 2.6 3 2 5.1 0 1.2 Chest Pain 2.4 2.5 2.7 1.7 2.4 2.9 Nausea 1.8 1 2.7 5.1 1.7 3.1 Dyspnea 1.8 0.5 2.7 3.4 1 2.2 Abdominal Discomfort 1.7 0 3.3 1.7 1.7 3.9 Tachycardia 1.5 1 1.3 3.4 0.3 0.5 Rash 1.5 1.5 2 1.7 0.3 0.7 Pollakiuria 1.5 2 1.3 3.4 0 <1 Weakness 1.2 0 0.7 0 0 1.2 Vomiting 1.1 1 1.3 0 0.3 0.2 Diarrhea 1.1 0 2.7 3.4 2 1.9 † Initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5 mg b.i.d. †† Initial dose of 2.5 mg b.i.d. followed by sequential titration to 5 mg b.i.d., 7.5 mg b.i.d., and maintenance dose of 10 mg b.i.d. * Propranolol, prazosin, hydrochlorothiazide, enalapril, captopril. Except for headache, which is not clearly drug-related (see previous table), the more frequent adverse reactions listed show little change, or increase slightly, in frequency over time, as shown in the following table: Incidence Rates for Isradipine (All Doses) by Week (%) Week N 1 694 2 906 3 649 4 847 5 432 6 494 Adverse Reaction Headache 6.5 6.1 5.2 5.2 5.8 4.5 Dizziness 1.6 1.9 1.7 2.2 2.3 2 Edema 1.2 2.5 3.2 3.2 5.3 5.5 Palpitations 1.2 1.3 1.4 1.9 2.1 1.4 Fatigue 0.4 1 1.4 1.2 1.2 1.6 Flushing 1.2 1.3 2 1.4 2.1 1.4 Week N 7 153 8 377 9 261 10 362 11 107 12 105 Adverse Reaction Headache 2 2.7 1.9 2.8 2.8 3.8 Dizziness 2 1.9 2.3 3.9 4.7 3.8 Edema 5.9 5 4.6 4.7 3.8 3.8 Palpitations 1.3 0.8 0.8 1.7 1.9 2.9 Fatigue 2 2.7 1.5 1.4 0.9 1.9 Flushing 3.3 1.3 1.1 0.8 0 0 Edema, palpitations, fatigue, and flushing appear to be dose-related, especially at the higher doses of 15 to 20 mg/day. In open-label, long-term studies of up to two years in duration, the adverse events 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 as in the controlled trials most adverse reactions were mild and transient. The following adverse experiences were reported in 0.5% to 1% of the isradipine-treated patients in hypertension studies, or are rare. More serious events from this and other data sources, including postmarketing exposure, are shown in italics. The relationship of these adverse events to isradipine administration is uncertain. Skin: pruritus, urticaria Musculoskeletal: cramps of legs/feet Respiratory: cough Cardiovascular: shortness of breath, hypotension, atrial fibrillation, ventricular fibrillation, myocardial infarction, heart failure Gastrointestinal: abdominal discomfort, constipation, diarrhea Urogenital: nocturia Nervous System: drowsiness, insomnia, lethargy, nervousness, impotence, decreased libido, depression , syncope, paresthesia (which includes numbness and tingling), transient ischemic attack, stroke Autonomic: hyperhidrosis, visual disturbance, dry mouth, numbness Miscellaneous: throat discomfort, leukopenia, elevated liver function tests

adverse reactions table

<table width="100%"><colgroup><col width="18%"/><col width="12%"/><col width="14%"/><col width="14%"/><col width="14%"/><col width="14%"/><col width="14%"/></colgroup><tbody><tr><td align="center" colspan="7" styleCode="Toprule"><paragraph><content styleCode="bold">Isradipine</content></paragraph></td></tr><tr><td/><td align="center"><paragraph><content styleCode="bold">All Doses</content></paragraph><paragraph><content styleCode="bold">N=934</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">2.5 mg b.i.d.</content></paragraph><paragraph><content styleCode="bold">199</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">5 mg b.i.d.<sup>&#x2020;</sup></content></paragraph><paragraph><content styleCode="bold">150</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">10 mg b.i.d.<sup>&#x2020;&#x2020;</sup></content></paragraph><paragraph><content styleCode="bold">59</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Placebo</content></paragraph><paragraph><content styleCode="bold">297</content></paragraph></td><td align="center"><paragraph><content styleCode="bold">Active Controls<sup>*</sup></content></paragraph><paragraph><content styleCode="bold">414</content></paragraph></td></tr><tr><td styleCode="Botrule"><paragraph><content styleCode="bold">Adverse</content></paragraph><paragraph><content styleCode="bold">Experience</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">%</content></paragraph></td></tr><tr><td><paragraph>Headache </paragraph></td><td align="center"><paragraph>13.7</paragraph></td><td align="center"><paragraph>12.6</paragraph></td><td align="center"><paragraph>10.7</paragraph></td><td align="center"><paragraph>22</paragraph></td><td align="center"><paragraph>14.1</paragraph></td><td align="center"><paragraph>9.4</paragraph></td></tr><tr><td><paragraph>Dizziness </paragraph></td><td align="center"><paragraph>7.3</paragraph></td><td align="center"><paragraph>8</paragraph></td><td align="center"><paragraph>5.3</paragraph></td><td align="center"><paragraph>3.4</paragraph></td><td align="center"><paragraph>4.4</paragraph></td><td align="center"><paragraph>8.2</paragraph></td></tr><tr><td><paragraph>Edema </paragraph></td><td align="center"><paragraph>7.2</paragraph></td><td align="center"><paragraph>3.5</paragraph></td><td align="center"><paragraph>8.7</paragraph></td><td align="center"><paragraph>8.5</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>2.9</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph>Palpitations</paragraph></td><td align="center" styleCode="Botrule"><paragraph>4</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>4.7</paragraph></td><td align="center" styleCode="Botrule"><paragraph>5.1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.4</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.5</paragraph></td></tr><tr><td><paragraph>Fatigue</paragraph></td><td align="center"><paragraph>3.9</paragraph></td><td align="center"><paragraph>2.5</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>8.5</paragraph></td><td align="center"><paragraph>0.3</paragraph></td><td align="center"><paragraph>6.3</paragraph></td></tr><tr><td><paragraph>Flushing</paragraph></td><td align="center"><paragraph>2.6</paragraph></td><td align="center"><paragraph>3</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>5.1</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>1.2</paragraph></td></tr><tr><td><paragraph>Chest Pain</paragraph></td><td align="center"><paragraph>2.4</paragraph></td><td align="center"><paragraph>2.5</paragraph></td><td align="center"><paragraph>2.7</paragraph></td><td align="center"><paragraph>1.7</paragraph></td><td align="center"><paragraph>2.4</paragraph></td><td align="center"><paragraph>2.9</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.8</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>2.7</paragraph></td><td align="center" styleCode="Botrule"><paragraph>5.1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.7</paragraph></td><td align="center" styleCode="Botrule"><paragraph>3.1</paragraph></td></tr><tr><td><paragraph>Dyspnea</paragraph></td><td align="center"><paragraph>1.8</paragraph></td><td align="center"><paragraph>0.5</paragraph></td><td align="center"><paragraph>2.7</paragraph></td><td align="center"><paragraph>3.4</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>2.2</paragraph></td></tr><tr><td><paragraph>Abdominal Discomfort</paragraph></td><td align="center"><paragraph>1.7</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>3.3</paragraph></td><td align="center"><paragraph>1.7</paragraph></td><td align="center"><paragraph>1.7</paragraph></td><td align="center"><paragraph>3.9</paragraph></td></tr><tr><td><paragraph>Tachycardia</paragraph></td><td align="center"><paragraph>1.5</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>1.3</paragraph></td><td align="center"><paragraph>3.4</paragraph></td><td align="center"><paragraph>0.3</paragraph></td><td align="center"><paragraph>0.5</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph>Rash</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.5</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.5</paragraph></td><td align="center" styleCode="Botrule"><paragraph>2</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.7</paragraph></td><td align="center" styleCode="Botrule"><paragraph>0.3</paragraph></td><td align="center" styleCode="Botrule"><paragraph>0.7</paragraph></td></tr><tr><td><paragraph>Pollakiuria</paragraph></td><td align="center"><paragraph>1.5</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>1.3</paragraph></td><td align="center"><paragraph>3.4</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>&lt;1</paragraph></td></tr><tr><td><paragraph>Weakness</paragraph></td><td align="center"><paragraph>1.2</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>0.7</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>1.2</paragraph></td></tr><tr><td><paragraph>Vomiting</paragraph></td><td align="center"><paragraph>1.1</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>1.3</paragraph></td><td align="center"><paragraph>0</paragraph></td><td align="center"><paragraph>0.3</paragraph></td><td align="center"><paragraph>0.2</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph>Diarrhea</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>0</paragraph></td><td align="center" styleCode="Botrule"><paragraph>2.7</paragraph></td><td align="center" styleCode="Botrule"><paragraph>3.4</paragraph></td><td align="center" styleCode="Botrule"><paragraph>2</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.9</paragraph></td></tr></tbody></table>

adverse reactions table

<table width="100%"><colgroup><col width="15%"/><col width="14%"/><col width="14%"/><col width="14%"/><col width="14%"/><col width="14%"/><col width="14%"/></colgroup><tbody><tr><td align="center" colspan="7" styleCode="Botrule Toprule"><paragraph><content styleCode="bold">Incidence Rates for Isradipine</content> <content styleCode="bold">(All Doses) by Week (%)</content></paragraph></td></tr><tr><td styleCode="Botrule"><paragraph><content styleCode="bold">Week</content> <content styleCode="bold"> N</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">1</content> <content styleCode="bold">694</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">2</content> <content styleCode="bold">906</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">3</content> <content styleCode="bold">649</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">4</content> <content styleCode="bold">847</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">5</content> <content styleCode="bold">432</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">6</content> <content styleCode="bold">494</content></paragraph></td></tr><tr><td colspan="7" styleCode="Botrule"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td></tr><tr><td><paragraph>Headache</paragraph></td><td align="center"><paragraph>6.5</paragraph></td><td align="center"><paragraph>6.1</paragraph></td><td align="center"><paragraph>5.2</paragraph></td><td align="center"><paragraph>5.2</paragraph></td><td align="center"><paragraph>5.8</paragraph></td><td align="center"><paragraph>4.5</paragraph></td></tr><tr><td><paragraph>Dizziness</paragraph></td><td align="center"><paragraph>1.6</paragraph></td><td align="center"><paragraph>1.9</paragraph></td><td align="center"><paragraph>1.7</paragraph></td><td align="center"><paragraph>2.2</paragraph></td><td align="center"><paragraph>2.3</paragraph></td><td align="center"><paragraph>2</paragraph></td></tr><tr><td><paragraph>Edema</paragraph></td><td align="center"><paragraph>1.2</paragraph></td><td align="center"><paragraph>2.5</paragraph></td><td align="center"><paragraph>3.2</paragraph></td><td align="center"><paragraph>3.2</paragraph></td><td align="center"><paragraph>5.3</paragraph></td><td align="center"><paragraph>5.5</paragraph></td></tr><tr><td><paragraph>Palpitations</paragraph></td><td align="center"><paragraph>1.2</paragraph></td><td align="center"><paragraph>1.3</paragraph></td><td align="center"><paragraph>1.4</paragraph></td><td align="center"><paragraph>1.9</paragraph></td><td align="center"><paragraph>2.1</paragraph></td><td align="center"><paragraph>1.4</paragraph></td></tr><tr><td><paragraph>Fatigue</paragraph></td><td align="center"><paragraph>0.4</paragraph></td><td align="center"><paragraph>1</paragraph></td><td align="center"><paragraph>1.4</paragraph></td><td align="center"><paragraph>1.2</paragraph></td><td align="center"><paragraph>1.2</paragraph></td><td align="center"><paragraph>1.6</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph>Flushing</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.2</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.3</paragraph></td><td align="center" styleCode="Botrule"><paragraph>2</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.4</paragraph></td><td align="center" styleCode="Botrule"><paragraph>2.1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.4</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph><content styleCode="bold">Week</content> <content styleCode="bold"> N</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">7</content> <content styleCode="bold">153</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">8</content> <content styleCode="bold">377</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">9</content> <content styleCode="bold">261</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">10</content> <content styleCode="bold">362</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">11</content> <content styleCode="bold">107</content></paragraph></td><td align="center" styleCode="Botrule"><paragraph><content styleCode="bold">12</content> <content styleCode="bold">105</content></paragraph></td></tr><tr><td colspan="7" styleCode="Botrule"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td></tr><tr><td><paragraph>Headache</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>2.7</paragraph></td><td align="center"><paragraph>1.9</paragraph></td><td align="center"><paragraph>2.8</paragraph></td><td align="center"><paragraph>2.8</paragraph></td><td align="center"><paragraph>3.8</paragraph></td></tr><tr><td><paragraph>Dizziness</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>1.9</paragraph></td><td align="center"><paragraph>2.3</paragraph></td><td align="center"><paragraph>3.9</paragraph></td><td align="center"><paragraph>4.7</paragraph></td><td align="center"><paragraph>3.8</paragraph></td></tr><tr><td><paragraph>Edema</paragraph></td><td align="center"><paragraph>5.9</paragraph></td><td align="center"><paragraph>5</paragraph></td><td align="center"><paragraph>4.6</paragraph></td><td align="center"><paragraph>4.7</paragraph></td><td align="center"><paragraph>3.8</paragraph></td><td align="center"><paragraph>3.8</paragraph></td></tr><tr><td><paragraph>Palpitations</paragraph></td><td align="center"><paragraph>1.3</paragraph></td><td align="center"><paragraph>0.8</paragraph></td><td align="center"><paragraph>0.8</paragraph></td><td align="center"><paragraph>1.7</paragraph></td><td align="center"><paragraph>1.9</paragraph></td><td align="center"><paragraph>2.9</paragraph></td></tr><tr><td><paragraph>Fatigue</paragraph></td><td align="center"><paragraph>2</paragraph></td><td align="center"><paragraph>2.7</paragraph></td><td align="center"><paragraph>1.5</paragraph></td><td align="center"><paragraph>1.4</paragraph></td><td align="center"><paragraph>0.9</paragraph></td><td align="center"><paragraph>1.9</paragraph></td></tr><tr><td styleCode="Botrule"><paragraph>Flushing</paragraph></td><td align="center" styleCode="Botrule"><paragraph>3.3</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.3</paragraph></td><td align="center" styleCode="Botrule"><paragraph>1.1</paragraph></td><td align="center" styleCode="Botrule"><paragraph>0.8</paragraph></td><td align="center" styleCode="Botrule"><paragraph>0</paragraph></td><td align="center" styleCode="Botrule"><paragraph>0</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.