Emtricitabine

Emtricitabine is a prescription medication used to treat the symptoms of HIV Infection. 

• Emtricitabine is available under the following different brand names: Emtriva

Common side effects of Emtricitabine include:

• Headache,
• Dizziness,
• Weakness,
• Indigestion,
• Stomach pain,
• Nausea,
• Vomiting,
• Diarrhoea,
• Sleep problems,
• Strange dreams,
• Rash,
• Skin discoloration, and
• Changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist)

Serious side effects of Emtricitabine include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Muscle pain,
• Weakness,
• Numb or cold feeling in the arms and legs,
• Stomach pain,
• Nausea with vomiting,
• Fast or uneven heart rate,
• Dizziness,
• Tiredness,
• Swelling around the midsection,
• Upper stomach pain,
• Nausea,
• Loss of appetite,
• Dark urine,
• Yellowing of the skin or eyes (jaundice),
• Fever,
• Night sweats,
• Swollen glands,
• Mouth sores,
• Diarrhea,
• Weight loss,
• Chest pain,
• Dry cough,
• Wheezing,
• Shortness of breath,
• Cold sores,
• Sores on the genital or anal area,
• Rapid heart rate,
• Anxiety,
• Irritableness,
• Weakness or prickly feeling,
• Problems with balance or eye movement,
• Trouble speaking or swallowing,
• Severe lower back pain,
• Loss of bladder or bowel control,
• Swelling in the neck or throat (enlarged thyroid),
• Menstrual changes,
• Impotence, and
• Loss of interest in sex

Rare side effects of Emtricitabine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 200 mg

Oral solution

• 10 mg/mL

HIV Infection

Adult dosage

• Capsule: 200 mg orally once a day
• Oral Solution: 240 mg orally once a day

Pediatric dosage

Oral solution

• below 3 months: 3 mg/kg orally once a day 
• 3 months to 17 years: 6 mg/kg orally once a day; not to exceed 240 mg/day (note: the oral solution has 20% lower plasma exposure, so the maximum daily dose is higher for the oral solution)

Capsule (weight above 33 kg)

• 200 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Emtricitabine has severe interactions with the following drugs
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • lamivudine
• Emtricitabine has serious interactions with the following drugs:
  • betibeglogene autotemcel
  • cabotegravir
  • elivaldogene autotemcel
• Emtricitabine has moderate interactions with at least 42 other drugs.
• Emtricitabine has minor interactions with the following drug:
  • nirmatrelvir/ritonavir

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Emtricitabine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Emtricitabine?”

Cautions

• All patients with HIV-1 should be tested for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy; safety and efficacy of emtricitabine not established in patients coinfected with HBV and HIV-1; patients infected with HBV and treated with emtricitabine, the exacerbations of hepatitis B were associated with liver decompensation and liver failure; hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue therapy; if appropriate, initiation of anti-Hepatitis B therapy may be warranted
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with the use of nucleoside analogs, either alone or in combination with other antiretrovirals; suspend therapy in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)
• Should not be coadministered with combination antiretroviral agents containing emtricitabine or lamivudine
• Dose reduction recommended in patients with impaired renal function
• Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) reported to occur in the setting of immune reconstitution; however, time to onset is more variable and can occur many months after initiation of treatment

Pregnancy and Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the drugs during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263
• Available data from the APR show no increase in overall risk of major birth defects with first-trimester exposure for emtricitabine (FTC) (2.3%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP); the rate of miscarriage for individual drugs is not reported in APR
• Lactation
  • The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1
  • Based on published data, FTC is present in human breast milk; it is not known if FTC affects milk production or has effects on the breastfed child
  • Because of the potential for HIV transmission (in HIV-negative infants); developing viral resistance (in HIV-positive infants); and adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking the drug