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The following adverse reactions are discussed in other sections of the labeling:

• Lactic acidosis/severe hepatomegaly with steatosis [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Severe acute exacerbations of Hepatitis B [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Immune reconstitution syndrome [See WARNINGS AND PRECAUTIONS]

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.

Table 2 : Selected Treatment-Emergent Adverse Reactions (All Grades, Regardless of Causality) Reported in ≥ 3% of EMTRIVA-Treated Patients in Either Study 301A or 303 (0–48 Weeks)

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.

Table 3 : Treatment-Emergent Grade 3/4 Laboratory Abnormalities Reported in ≥ 1% of EMTRIVA-Treated Patients in Either Study 301A or 303

Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviralnaïve 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).

Table 4 : Selected Treatment-Emergent Adverse Reactions^a (Grades 2–4) Reported in ≥ 5% in Any Treatment Group in Study 934 (0–144 Weeks)

Study 934 – Laboratory Abnormalities: Significant laboratory abnormalities observed in this study are shown in Table 5.

Table 5 : Significant Laboratory Abnormalities Reported in ≥ 1% of Patients in Any Treatment Group in Study 934 (0–144 Weeks)

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]. 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 x ULN (n=4), neutrophils < 750/mm³ (n=3), ALT > 5 x ULN (n=2), elevated CPK ( > 4 x ULN) (n=2) and one patient each with elevated bilirubin ( > 3.0 x ULN), elevated GGT ( > 10 x ULN), elevated lipase ( > 2.5 x ULN), decreased hemoglobin ( < 7 g/dL), and decreased glucose ( < 40 mg/dL).

The potential for drug interactions with EMTRIVA has been studied in combination with zidovudine, indinavir, stavudine, famciclovir, and tenofovir disoproxil fumarate. There were no clinically significant drug interactions for any of these drugs Drug interactions studies are described elsewhere in the labeling [See CLINICAL PHARMACOLOGY]

Last reviewed on RxList: 12/8/2011
This monograph has been modified to include the generic and brand name in many instances.