Emtriva Side Effects
Generic Name: emtricitabine
Please note - some side effects for Emtriva 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 Emtriva - for the Consumer
Emtriva
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 Emtriva:
Seek medical attention right away if any of these SEVERE side effects occur when using Emtriva:Abnormal dreams; change in color of skin on palms or soles of feet; cough; diarrhea; dizziness; headache; indigestion or stomach upset; joint or muscle pain; mild stomach pain; nausea; runny nose; sleeplessness; tiredness; vomiting; weakness or lack of energy.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; depression; fast or difficult breathing; fast, slow, or irregular heartbeat; feeling unusually cold; fever, chills, or sore throat; general feeling of being unwell; muscle pain or tenderness; severe or persistent cough; severe or persistent nausea or vomiting; severe or persistent stomach discomfort, pain, or tenderness; sluggishness; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the eyes or skin); unusual drowsiness, dizziness, or light-headedness; unusual muscle pain or tenderness; unusual tiredness or weakness.
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.
Emtriva Solution
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 Emtriva Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Emtriva Solution:Abnormal dreams; change in color of skin on palms or soles of feet; cough; diarrhea; dizziness; headache; indigestion or stomach upset; joint or muscle pain; mild stomach pain; nausea; runny nose; sleeplessness; tiredness; vomiting; weakness or lack of energy.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; depression; fast or difficult breathing; fast, slow, or irregular heartbeat; feeling unusually cold; fever, chills, or sore throat; general feeling of being unwell; muscle pain or tenderness; severe or persistent cough; severe or persistent nausea or vomiting; severe or persistent stomach discomfort, pain, or tenderness; sluggishness; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the eyes or skin); unusual drowsiness, dizziness, or light-headedness; unusual muscle pain or tenderness; unusual tiredness or weakness.
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.
TopEmtriva Side Effects - for the Professional
Emtriva
The following adverse reactions are discussed in other sections of the labeling:
- Lactic acidosis/severe hepatomegaly with steatosis [See Boxed Warning, Warnings and Precautions (5.1)].
- Severe acute exacerbations of Hepatitis B [See Boxed Warning, Warnings and Precautions (5.2)].
- Immune reconstitution syndrome [See Warnings and Precautions (5.6)]
Adverse Reactions from Clinical Trials Experience
Adult Patients
More than 2,000 adult patients with HIV-1 infection have been treated with Emtriva alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions (incidence ≥10%, any severity) identified from any of the 3 large controlled clinical trials include headache, diarrhea nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.
Studies 301A and 303 - Treatment Emergent Adverse Reactions: The most common adverse reactions that occurred in patients receiving Emtriva with other antiretroviral agents in clinical studies 301A and 303 were headache, diarrhea, nausea, and rash, which were generally of mild to moderate severity. Approximately 1% of patients discontinued participation in the clinical studies due to these events. All adverse reactions were reported with similar frequency in Emtriva and control treatment groups with the exception of skin discoloration which was reported with higher frequency in the Emtriva treated group.
Skin discoloration, manifested by hyperpigmentation on the palms and/or soles was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
A summary of Emtriva treatment emergent clinical adverse reactions in studies 301A and 303 is provided in Table 2.
| 303 | 301A | |||
|---|---|---|---|---|
| Emtriva + ZDV/d4T + NNRTI/PI (N=294) |
Lamivudine + ZDV/d4T + NNRTI/PI (N=146) |
Emtriva + didanosine + efavirenz (N=286) |
Stavudine + didanosine + efavirenz (N=285) |
|
|
||||
| Body as a Whole | ||||
| Abdominal pain | 8% | 11% | 14% | 17% |
| Asthenia | 16% | 10% | 12% | 17% |
| Headache | 13% | 6% | 22% | 25% |
| Digestive System | ||||
| Diarrhea | 23% | 18% | 23% | 32% |
| Dyspepsia | 4% | 5% | 8% | 12% |
| Nausea | 18% | 12% | 13% | 23% |
| Vomiting | 9% | 7% | 9% | 12% |
| Musculoskeletal | ||||
| Arthralgia | 3% | 4% | 5% | 6% |
| Myalgia | 4% | 4% | 6% | 3% |
| Nervous System | ||||
| Abnormal dreams | 2% | <1% | 11% | 19% |
| Depressive disorders | 6% | 10% | 9% | 13% |
| Dizziness | 4% | 5% | 25% | 26% |
| Insomnia | 7% | 3% | 16% | 21% |
| Neuropathy/peripheral neuritis | 4% | 3% | 4% | 13% |
| Paresthesia | 5% | 7% | 6% | 12% |
| Respiratory | ||||
| Increased cough | 14% | 11% | 14% | 8% |
| Rhinitis | 18% | 12% | 12% | 10% |
| Skin | ||||
| Rash event* | 17% | 14% | 30% | 33% |
Studies 301A and 303 - Laboratory Abnormalities:
Laboratory abnormalities in these studies occurred with similar frequency in the Emtriva and comparator groups. A summary of Grade 3 and 4 laboratory abnormalities is provided in Table 3 below.
| 303 | 301A | |||
|---|---|---|---|---|
| Emtriva + ZDV/d4T + NNRTI/PI (N=294) |
Lamivudine + ZDV/d4T + NNRTI/PI (N=146) |
Emtriva + Didanosine + Efavirenz (N=286) |
Stavudine + Didanosine + Efavirenz (N=285) |
|
|
||||
| Percentage with grade 3 or grade 4 laboratory abnormality | 31% | 28% | 34% | 38% |
| ALT (>5.0 × ULN*) | 2% | 1% | 5% | 6% |
| AST (>5.0 × ULN) | 3% | <1% | 6% | 9% |
| Bilirubin (>2.5 × ULN) | 1% | 2% | <1% | <1% |
| Creatine kinase (>4.0 × ULN) |
11% | 14% | 12% | 11% |
| Neutrophils (<750 mm3) | 5% | 3% | 5% | 7% |
| Pancreatic amylase (>2.0 × ULN) |
2% | 2% | <1% | 1% |
| Serum amylase (>2.0 × ULN) |
2% | 2% | 5% | 10% |
| Serum glucose <40 or >250 mg/dL) |
3% | 3% | 2% | 3% |
| Serum lipase (>2.0 × ULN) |
<1% | <1% | 1% | 2% |
| Triglycerides (>750 mg/dL) |
10% | 8% | 9% | 6% |
Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviral-naïve patients received either VIREAD + Emtriva administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254). Adverse reactions observed in this study were generally consistent with those seen in previous studies in treatment-experienced or treatment-naïve patients (Table 4).
| TDF† + Emtriva + EFV | AZT/3TC + EFV | |
|---|---|---|
| N=257 | N=254 | |
|
||
| Gastrointestinal Disorder | ||
| Diarrhea | 9% | 5% |
| Nausea | 9% | 7% |
| Vomiting | 2% | 5% |
| General Disorders and Administration Site Condition | ||
| Fatigue | 9% | 8% |
| Infections and Infestations | ||
| Sinusitis | 8% | 4% |
| Upper respiratory tract infections | 8% | 5% |
| Nasopharyngitis | 5% | 3% |
| Nervous System Disorders | ||
| Headache | 6% | 5% |
| Dizziness | 8% | 7% |
| Psychiatric Disorders | ||
| Depression | 9% | 7% |
| Insomnia | 5% | 7% |
| Skin and Subcutaneous Tissue Disorders | ||
| Rash event‡ | 7% | 9% |
Study 934 – Laboratory Abnormalities: Significant laboratory abnormalities observed in this study are shown in Table 5.
| TDF* + Emtriva + EFV | AZT/3TC + EFV | |
|---|---|---|
| N=257 | N=254 | |
|
||
| Any ≥ Grade 3 Laboratory Abnormality | 30% | 26% |
| Fasting Cholesterol (>240 mg/dL) | 22% | 24% |
| Creatine Kinase (M: >990 U/L) (F: >845 U/L) |
9% | 7% |
| Serum Amylase (>175 U/L) | 8% | 4% |
| Alkaline Phosphatase (>550 U/L) | 1% | 0% |
| AST (M: >180 U/L) (F: >170 U/L) |
3% | 3% |
| ALT (M: >215 U/L) (F: >170 U/L) |
2% | 3% |
| Hemoglobin (<8.0 mg/dL) | 0% | 4% |
| Hyperglycemia (>250 mg/dL) | 2% | 1% |
| Hematuria (>75 RBC/HPF) | 3% | 2% |
| Glycosuria (3+) | <1% | 1% |
| Neutrophils (<750/mm3) | 3% | 5% |
| Fasting Triglycerides (>750 mg/dL) | 4% | 2% |
Pediatric Patients
Assessment of adverse reactions is based on data from Study 203, an open label, uncontrolled study of 116 HIV-1-infected pediatric patients who received emtricitabine through 48 weeks. The adverse reaction profile in pediatric patients was generally comparable to that observed in clinical studies of Emtriva in adult patients [See Adverse Reactions (6.1)]. Hyperpigmentation was more frequent in children. Additional adverse reactions identified from this study include anemia.
Selected treatment-emergent adverse events, regardless of causality, reported in patients during 48 weeks of treatment were the following: infection (44%), hyperpigmentation (32%), increased cough (28%), vomiting (23%), otitis media (23%), rash (21%), rhinitis (20%), diarrhea (20%), fever (18%), pneumonia (15%), gastroenteritis (11%), abdominal pain (10%), and anemia (7%). Treatment-emergent grade 3/4 laboratory abnormalities were experienced by 9% of pediatric patients, including amylase >2.0 × ULN (n=4), neutrophils <750/mm3 (n=3), ALT >5 × ULN (n=2), elevated CPK (>4 × ULN) (n=2) and one patient each with elevated bilirubin (>3.0 × ULN), elevated GGT (>10 × ULN), elevated lipase (>2.5 × ULN), decreased hemoglobin (<7 g/dL), and decreased glucose (<40 mg/dL).
TopSide Effects by Body System - for Healthcare Professionals
General
The most common side effects reported during any of 3 large controlled clinical trials were headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.
During 2 clinical trials, the most common side effects associated with emtricitabine in combination with other antiretrovirals were headache, diarrhea, nausea, and rash. Most were of mild to moderate severity. Treatment was discontinued due to these adverse effects in approximately 1% of patients.
Side effects have been reported for emtricitabine when taken in combination with other antiretroviral agents.
Dermatologic
Dermatological side effects have included rash event (any Grade: up to 30%; Grades 2 to 4: 7%). "Rash event" included rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash, and allergic reaction. Skin discoloration (palmar-plantar hyperpigmentation) has been reported.
Nervous system
Nervous system side effects have included dizziness (any Grade: up to 25%; Grades 2 to 4: 8%), headache (any Grade: up to 22%; Grades 2 to 4: 6%), insomnia (any Grade: up to 16%; Grades 2 to 4: 5%), paresthesia (any Grade: up to 6%), neuropathy/peripheral neuritis (any Grade: 4%), and somnolence.
Gastrointestinal
Gastrointestinal side effects have included diarrhea (any Grade: 23%; Grades 2 to 4: 9%), nausea (any Grade: up to 18%; Grades 2 to 4: 9%), vomiting (any Grade: 9%; Grades 2 to 4: 2%), and dyspepsia (any Grade: up to 8%).
Metabolic
Metabolic side effects have included blood glucose changes (less than 40 or greater than 250 mg/dL; up to 3%), hyperglycemia (greater than 250 mg/dL; 2%), and increased fasting cholesterol (greater than 240 mg/dL; 22%), triglycerides (greater than 750 mg/dL; up to 10%), serum amylase (greater than 2 times ULN: up to 5%; greater than 175 units/L: 8%), fasting triglycerides (greater than 750 mg/dL; 4%), pancreatic amylase (greater than 2 times ULN; up to 2%), serum lipase (greater than 2 times ULN; up to 1%), and alkaline phosphatase (greater than 550 units/L; 1%). Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy.
Respiratory
Respiratory side effects have included rhinitis (any Grade: up to 18%), increased cough (any Grade: 14%), sinusitis (Grades 2 to 4: 8%), upper respiratory tract infections (Grades 2 to 4: 8%), and nasopharyngitis (Grades 2 to 4: 5%).
Other
Other side effects have included asthenia (any Grade: up to 16%), abdominal pain (any Grade: up to 14%), and fatigue (Grades 2 to 4: 9%).
Musculoskeletal
Increased creatine kinase (greater than 990 units/L in males and 845 units/L in females) has been reported in 9% of patients.
Musculoskeletal side effects have included elevated creatine kinase (greater than 4 times ULN; up to 12%), myalgia (any Grade: up to 6%), and arthralgia (any Grade: up to 5%).
Psychiatric
Psychiatric side effects have included abnormal dreams (any Grade: up to 11%), depressive disorders (any Grade: up to 9%), and depression (Grades 2 to 4: 9%).
Hepatic
Increased AST (greater than 180 units/L in males and 170 units/L in females) has been reported in 3% of patients. Increased ALT (greater than 215 units/L in males and 170 units/L in females) has been reported in 2% of patients.
Hepatic side effects have included elevated AST (greater than 5 times ULN; up to 6%), ALT (greater than 5 times ULN; up to 5%), and bilirubin (greater than 2.5 times ULN; up to 1%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of emtricitabine and other nucleoside analogs alone or in combination with other antiretroviral agents. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and hepatitis B after discontinuation of emtricitabine and were associated with liver failure and liver decompensation in some patients.
Immunologic
Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.
Hematologic
Hematologic side effects have included decreased neutrophils (less than 750/mm3; up to 5%).
Genitourinary
Genitourinary side effects have included hematuria (greater than 75 RBC/HPF; 3%) and glycosuria (3 plus; less than 1%).
TopMore Emtriva resources
- Emtriva Prescribing Information (FDA)
- Emtriva Monograph (AHFS DI)
- Emtriva Advanced Consumer (Micromedex) - Includes Dosage Information
- Emtriva Consumer Overview
- Emtriva MedFacts Consumer Leaflet (Wolters Kluwer)
- Emtricitabine Professional Patient Advice (Wolters Kluwer)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
