FDA label 2f9ea569-030d-49fc-9181-0594d07bab53

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)

SPL set ID
4c9367a4-56af-4f37-b5dc-cfd54596dec2
SPL ID
2f9ea569-030d-49fc-9181-0594d07bab53
Version
25
Effective date
2017-10-23
Source export date
2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:41:40

Boxed warning cross-check#

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Boxed warning sections page 1 of 1 · 3 matching rows.

boxed warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

boxed warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

boxed warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Warnings cross-check#

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Warnings sections page 5 of 6 · 23 matching rows.

warnings

10. Headache The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.

warnings

11. Bleeding Irregularities Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal causes should be considered, and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.

warnings table

<table> <caption>TABLE II: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE</caption> <col/> <tbody> <tr> <td> <paragraph> <renderMultiMedia referencedObject="MM3"/> </paragraph> </td> </tr> </tbody> </table>

warnings table

<table width="631px"> <caption>TABLE III: ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NON-STERILE WOMEN BY FERTILITY CONTROL METHOD ACCORDING TO AGE</caption> <col width="1px"/> <col width="1px"/> <col width="1px"/> <col width="1px"/> <col width="1px"/> <col width="1px"/> <col/> <tbody> <tr> <td valign="top" styleCode=" Botrule Toprule Lrule "> <content styleCode="bold">Method of control and outcome</content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule "> <content styleCode="bold">15 to 19</content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule "> <content styleCode="bold">20 to 24</content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule "> <content styleCode="bold">25 to 29</content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule "> <content styleCode="bold">30 to 34</content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule "> <content styleCode="bold">35 to 39</content> </td> <td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">40 to 44</content> </td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> No fertility control methods*</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 7.0</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 7.4</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 9.1</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 14.8</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 25.7</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 28.2</td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> Oral contraceptives non- smoker**</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.3</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.5</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.9</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.9</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 13.8</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 31.6</td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> Oral contraceptives smoker**</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 2.2</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 3.4</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 6.6</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 13.5</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 51.1</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 117.2</td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> IUD**</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.8</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.8</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.0</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.0</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.4</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 1.4</td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> Condom*</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.1</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.6</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.7</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.2</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 0.3</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 0.4</td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> Diaphragm/spermicide*</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.9</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.2</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.2</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.3</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 2.2</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 2.8</td> </tr> <tr> <td valign="top" styleCode=" Botrule Lrule "> Periodic abstinence*</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 2.5</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.6</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.6</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 1.7</td> <td align="center" valign="top" styleCode=" Botrule Lrule "> 2.9</td> <td align="center" valign="top" styleCode=" Botrule Lrule Rrule "> 3.6</td> </tr> </tbody> </table>

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Nausea Vomiting Gastrointestinal symptoms (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Temporary infertility after discontinuation of treatment Edema Melasma which may persist Breast changes: tenderness, enlargement, secretion Change in weight (increase or decrease) Change in cervical erosion and secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine Rash (allergic) Mental depression Reduced tolerance to carbohydrates Vaginal candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Budd-Chiari syndrome Acne Changes in libido Colitis

Reported adverse events (FAERS/openFDA)#

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