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Effient Side Effects

Please note - some side effects for Effient may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


Side Effects of Effient - for the Consumer

Effient

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Effient:

Back pain; cough; diarrhea; mild bruising or bleeding; nausea; nosebleeds; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Effient:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; change in the amount of urine; chest pain; confusion; coughing up blood; dark or bloody urine; dizziness; fast or irregular heartbeat; fever, chills, or persistent sore throat; one-sided weakness; pale skin; purple spots on the skin; seizure; severe or persistent headache; severe or persistent nosebleeds; shortness of breath; speech problems; stomach pain; unusual bruising; unusual or severe bleeding (eg, excessive bleeding from cuts , increased menstrual bleeding, unexplained vaginal bleeding, unusual bleeding from the gums when brushing); unusual tiredness or weakness; vision changes; vomit that contains blood or looks like coffee grounds; yellowing of the skin or eyes.

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Effient Side Effects - for the Professional

Effient

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch



See 17 for PATIENT COUNSELING INFORMATION and Medication Guide

Revised: 07/2009
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

WARNING: BLEEDING RISK

1 INDICATIONS AND USAGE

1.1 Acute Coronary Syndrome

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Active Bleeding

4.2 Prior Transient Ischemic Attack or Stroke

5 WARNINGS AND PRECAUTIONS

5.1 General Risk of Bleeding

5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding

5.3 Discontinuation of Effient

5.4 Thrombotic Thrombocytopenic Purpura

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Warfarin

7.2 Non-Steroidal Anti-Inflammatory Drugs

7.3 Other Concomitant Medications

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Low Body Weight

8.7 Renal Impairment

8.8 Hepatic Impairment

8.9 Metabolic Status

10 OVERDOSAGE

10.1 Signs and Symptoms

10.2 Recommendations about Specific Treatment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Benefits and Risks

17.2 Bleeding

17.3 Other Signs and Symptoms Requiring Medical Attention

17.4 Invasive Procedures

17.5 Concomitant Medications

MEDICATION GUIDE


FULL PRESCRIBING INFORMATION
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Side Effects by Body System

Musculoskeletal

Musculoskeletal side effects have included back pain, noncardiac chest pain, and pain in extremity.

General

General side effects have included fatigue and pyrexia.

Metabolic

Metabolic side effects have included hypercholesterolemia and hyperlipidemia.

Nervous system

Nervous system side effects have included headache and dizziness.

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More resources:

Drugs.com Effient

MedFacts Effient

FDA Effient

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