Effient Side Effects

Generic Name: prasugrel

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.

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; headache; 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 or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry stools; change in the amount of urine produced; chest pain; confusion; coughing up blood; dark or bloody urine; dizziness; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; one-sided weakness; pale skin; purple spots on the skin or mouth; seizure; severe or persistent headache; severe or persistent nausea, vomiting, or diarrhea; 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 (eg, blurred vision); vomit that contains blood or looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Effient Side Effects - for the Professional

Effient

Clinical Trials Experience

The following serious adverse reactions are also discussed elsewhere in the labeling:

• Bleeding [see Boxed Warning and Warnings and Precautions (5.1, 5.2)]
• Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.4)]

Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with Effient (60 mg loading dose and 10 mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year). The population treated with Effient was 27 to 96 years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive aspirin. The dose of clopidogrel in this study was a 300 mg loading dose and 75 mg once daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared with the rates observed in other clinical trials of another drug and may not reflect the rates observed in practice.

Drug Discontinuation

The rate of study drug discontinuation because of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient and 1.4% for clopidogrel).

Bleeding

Bleeding Unrelated to CABG Surgery - In TRITON-TIMI 38, overall rates of TIMI Major or Minor bleeding adverse reactions unrelated to coronary artery bypass graft surgery (CABG) were significantly higher on Effient than on clopidogrel, as shown in Table 1.

Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38)

	Effient (%) (N=6741)	Clopidogrel (%) (N=6716)	p-value
a Patients may be counted in more than one row.
b See 5.1 for definition.
TIMI Major or Minor bleeding	4.5	3.4	p=0.002
TIMI Major bleedingb	2.2	1.7	p=0.029
Life-threatening	1.3	0.8	p=0.015
Fatal	0.3	0.1
Symptomatic intracranial hemorrhage (ICH)	0.3	0.3
Requiring inotropes	0.3	0.1
Requiring surgical intervention	0.3	0.3
Requiring transfusion (≥4 units)	0.7	0.5
TIMI Minor bleedingb	2.4	1.9	p=0.022

Figure 1 demonstrates non-CABG related TIMI Major or Minor bleeding. The bleeding rate is highest initially, as shown in Figure 1 (inset: Days 0 to 7) [see Warnings and Precautions (5.1)].

Bleeding rates in patients with the risk factors of age ≥ 75 years and weight < 60 kg are shown in Table 2.

Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38)

	Major/Minor		Fatal
	Effient (%)	Clopidogrel (%)	Effient (%)	Clopidogrel (%)
Weight < 60 kg (N=308 Effient, N=356 clopidogrel)	10.1	6.5	0.0	0.3
Weight ≥ 60 kg (N=6373 Effient, N=6299 clopidogrel)	4.2	3.3	0.3	0.1
Age < 75 years (N=5850 Effient, N=5822 clopidogrel)	3.8	2.9	0.2	0.1
Age ≥ 75 years (N=891 Effient, N=894 clopidogrel)	9.0	6.9	1.0	0.1

Bleeding Related to CABG - In TRITON-TIMI 38, 437 patients who received a thienopyridine underwent CABG during the course of the study. The rate of CABG-related TIMI Major or Minor bleeding was 14.1% for the Effient group and 4.5% in the clopidogrel group (Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient persisted up to 7 days from the most recent dose of study drug.

Table 3: CABG-Related Bleedinga (TRITON-TIMI 38)

	Effient (%) (N=213)	Clopidogrel (%) (N=224)
a Patients may be counted in more than one row.
TIMI Major or Minor bleeding	14.1	4.5
TIMI Major bleeding	11.3	3.6
Fatal	0.9	0
Reoperation	3.8	0.5
Transfusion of ≥5 units	6.6	2.2
Intracranial hemorrhage	0	0
TIMI Minor bleeding	2.8	0.9

Bleeding Reported as Adverse Reactions - Hemorrhagic events reported as adverse reactions in TRITON-TIMI 38 were, for Effient and clopidogrel, respectively: epistaxis (6.2%, 3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous hematoma (0.5%, 0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).

Malignancies

During TRITON-TIMI 38, newly diagnosed malignancies were reported in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The sites contributing to the differences were primarily colon and lung. It is unclear if these observations are causally-related or are random occurrences.

Other Adverse Events

In TRITON-TIMI 38, common and other important non-hemorrhagic adverse events were, for Effient and clopidogrel, respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic reactions (0.36%, 0.36%), and angioedema (0.06%, 0.04%). Table 4 summarizes the adverse events reported by at least 2.5% of patients.

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group

	Effient (%) (N=6741)	Clopidogrel (%) (N=6716)
Hypertension	7.5	7.1
Hypercholesterolemia/Hyperlipidemia	7.0	7.4
Headache	5.5	5.3
Back pain	5.0	4.5
Dyspnea	4.9	4.5
Nausea	4.6	4.3
Dizziness	4.1	4.6
Cough	3.9	4.1
Hypotension	3.9	3.8
Fatigue	3.7	4.8
Non-cardiac chest pain	3.1	3.5
Atrial fibrillation	2.9	3.1
Bradycardia	2.9	2.4
Leukopenia (< 4 x 109 WBC/L)	2.8	3.5
Rash	2.8	2.4
Pyrexia	2.7	2.2
Peripheral edema	2.7	3.0
Pain in extremity	2.6	2.6
Diarrhea	2.3	2.6

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Effient. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders - Thrombocytopenia, Thrombotic thrombocytopenic purpura (TTP) [see Warnings and Precautions (5.4) and Patient Counseling Information (17.3)]

Immune system disorders - Hypersensitivity reactions including anaphylaxis [see Contraindications (4.3)]

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Side Effects by Body System - for Healthcare Professionals

Hematologic

Hematologic side effects have included bleeding, including symptomatic intracranial hemorrhage, thrombotic thrombocytopenic purpura, thrombocytopenia, anemia, and leukopenia.

Cardiovascular

Cardiovascular side effects have included hypertension, hypotension, atrial fibrillation, peripheral edema, and bradycardia.

Respiratory

Respiratory side effects have included dyspnea and cough.

Musculoskeletal

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

Dermatologic

Dermatologic side effects have included rash.

General

General side effects have included fatigue and pyrexia.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Metabolic

Metabolic side effects have included hypercholesterolemia and hyperlipidemia.

Nervous system

Nervous system side effects have included headache and dizziness.

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