ORTHO TRI-CYCLEN: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceutical, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. (7.1)

USE IN SPECIFIC POPULATIONS
Nursing mothers: Not recommended; can decrease milk production. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2016

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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS
1 INDICATIONS AND USAGE
1.1 Oral Contraceptive 1.2 Acne 2 DOSAGE AND ADMINISTRATION
2.1 How to Start ORTHO-CYCLEN or ORTHO TRI-CYCLEN 2.2 How to Take ORTHO-CYCLEN or ORTHO TRI-CYCLEN 2.3 Missed Tablets 2.4 Advice in Case of Gastrointestinal Disturbances 2.5 ORTHO-TRICYCLEN Use for Acne 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Disorders and Other Vascular Problems 5.2 Liver Disease 5.3 High Blood Pressure 5.4 Gallbladder Disease 5.5 Carbohydrate and Lipid Metabolic Effects 5.6 Headache 5.7 Bleeding Irregularities and Amenorrhea 5.8 COC Use Before or During Early Pregnancy 5.9 Depression 5.10 Carcinoma of Breast and Cervix 5.11 Effect on Binding Globulins 5.12 Monitoring 5.13 Hereditary Angioedema 5.14 Chloasma 6 ADVERSE REACTIONS
6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Combined Oral Contraceptives 7.2 Effects of Combined Oral Contraceptives on Other Drugs 7.3 Interference with Laboratory Tests 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Contraception 14.2 Acne 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied 16.2 Storage Conditions 17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE

1.1 Oral ContraceptiveORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].

1.2 AcneORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCL