Truvada Side Effects

The HIV pre-exposure prophylaxis, or PrEP, drug Truvada — emtricitabine and tenofovir disoproxil fumarate — has common side effects including headaches, abdominal pain and weight loss. Rare but serious side effects include kidney problems, bone loss and potentially fatal lactic acidosis. The HIV medication has a black box warning for potential worsening of hepatitis B in people who stop treatment.

Truvada Pill
Truvada Side Effects Facts
  1. Common Side Effects Depression, weight loss, diarrhea, headache, nausea, rash, vomiting, dizziness and physical weakness or lack of energy known as asthenia
  2. Serious Side Effects Kidney problems, bone loss, lactic acidosis and immune reconstitution syndrome
  3. Black Box Warning Post-treatment acute exacerbation of hepatitis B and risk of drug resistance with use of Truvada for HIV-1 pre-exposure prophylaxis, or PrEP, in undiagnosed early HIV-1 infection

According to the U.S. Food and Drug Administration’s Adverse Event Reporting System, or FAERS, there have been 10,517 adverse event reports for Truvada from 2005 to June 30, 2019. Of those, 8,359 were serious, including 691 deaths.

FAERS gathers voluntary reported data from manufacturers, doctors, patients and others to get an idea of the side effects of a drug in real world practice. However, the FDA cannot verify the drug actually caused the problem.

Truvada has a black box warning for post-treatment acute exacerbation of hepatitis B, or HBV. Patients who discontinue TDF treatment may have severe flare ups of HBV symptoms, and they may need to restart hepatitis therapy.

Most common side effects are temporary and mild, lasting a month or less. The most serious long-term side effects of Truvada are kidney problems and bone loss.

People who suffered these serious side effects filed lawsuits against Gilead Sciences, Inc. Court documents say the drug maker failed to properly warn the public of these risks.

Common Emtricitabine/Tenofovir Side Effects

Common side effects related to Truvada may vary depending on HIV infection, HBV infection and kidney health, according to the medication insert.

About 1 in 10 people experience these short-term side effects, most often at the beginning of treatment, according to a 2017 study by researcher Raymon A. Tetteh and fellow authors. The side effects typically go away within a month, the same study found.

Reported side effects in clinical trials for adult patients taking Truvada include:
  • Abdominal pain
  • Fatigue
  • Upper respiratory tract infection
  • Sinusitis
  • Insomnia
  • Back pain
  • Depression
  • Diarrhea
  • Dizziness
  • Headache
  • Itching or skin rash
  • Joint pain
  • Nausea
  • Skin discoloration and hyperpigmentation
  • Stomach pain
  • Strange dreams
  • Trouble sleeping
  • Vomiting
  • Weight loss

Pediatric patients suffered the same side effects as adults.

While the majority of Truvada’s side effects are short-term, the drug also has warnings for potentially serious long-term side effects, including kidney problems and bone density loss.

Experts recommend regular renal function and bone density monitoring to avoid long-term side effects.

Can Truvada Cause Hair Loss?

Some HIV medications may be linked to hair loss. For example, Indinavir and Lamivudine are two drugs with reports of hair loss.

However, there have been no clinical trials or postmarket reports that link Truvada to hair loss. If you experience this side effect while taking this drug, let your health care provider know.

Kidney Problems

Truvada has warnings for new onset or worsening kidney impairment on its label. Kidney impairment can include acute renal failure and Fanconi syndrome.

Fanconi syndrome is a rare condition that affects the function of the kidney tubules. Patients suffering from Fanconi syndrome excrete an overabundance of glucose, bicarbonate, phosphates, uric acid, potassium and certain amino acids in their urine, which can lead to worsening kidney damage and bone problems.

Before patients begin Truvada treatment, health care providers should test kidney function.

Signs of renal tubulopathy, a possible kidney problem linked to Truvada, include:
  1. Persistent bone pain
  2. Pain in extremities
  3. Fractures
  4. Muscular pain or weakness

Source: Truvada Medication Insert

Several studies link TDF, one of the ingredients in Truvada, to kidney problems.

Clinical trial data reassured doctors that TDF would not have the same kidney toxicity as other drugs in its class. Yet, researchers published the first case of TDF-induced acute nephrotoxicity in 2001, according to Dr. Jérôme Tourret and colleagues in a 2013 article in Journal of the American Society of Nephrology.

“Numerous cases have been published since then, and it is now established that TDF presents a tubular toxicity risk,” the study authors wrote.

“[I]t is now established that TDF presents a tubular toxicity risk.”

Dr. Jérôme Tourret and colleagues in the Journal of the American Society of Nephrology

According to Truvada’s label, some HIV-infected patients who started high-dose or multiple NSAIDs reported acute renal failure. Some patients ended up hospitalized and on renal replacement therapy.

Bone Density Loss

In general, osteopenia and osteoporosis occur in 40 to 90 percent of HIV-infected people. People with HIV also have a 60 percent increased fracture risk compared to people who are not infected.

Truvada for PrEP or HIV treatment may increase the risk of bone mineral density loss.

According to Truvada’s drug label, cases of weakened bone called osteomalacia linked to kidney damage may manifest as bone pain or pain in the extremities.

Researchers noted markers of increased bone metabolism in people taking the drug. Bone metabolism is a sign of bone turnover. Bone turnover is the rate at which the body reabsorbs bone. An increase in bone turnover can increase the risk of fracture.

Trials also found that bone growth in pediatric patients — which is normally rapid — was the same as it was for adult patients and could indicate increased bone turnover.

Normal bone density and osteoporotic bone loss
An example of normal bone density (left) and osteoporotic bone loss (right).

A 2016 study by Philip M. Grant and Aoife G. Cotter in the journal Current Opinion in HIV and AIDS found a one to three percent greater bone mineral density loss with TDF compared to other HIV drugs.

However, a small 2017 study in International Journal of Antimicrobial Agents that followed 26 HIV-infected youths for ten years found that TDF-containing drugs did not impair bone mineral density in young patients.

“Larger studies are needed to confirm these results,” authors V. Giacomet and colleagues wrote.

Immune Reconstitution Syndrome

Immune reconstitution syndrome — also called immune reconstitution inflammatory syndrome, or IRIS — is a collection of disorders that occurs when preexisting infections get worse after starting highly active antiretroviral therapy drugs such as Truvada.

This condition can occur in about 10 to 40 percent of HIV patients with low CD4+ T-cell counts. A T-cell is a white blood cell that helps the immune system. A T-cell count of less than 50/μL and a high amount of HIV in the blood are the most common risk factors for IRIS, according to Martyn A. H. French’s article in The Medical Journal of Australia.

Patients with IRIS may develop symptoms anywhere from one week to a few months after starting therapy.

During the initial phase of TDF therapy, patients may experience infections such as pneumonia, cytomegalovirus, Mycobacterium avium infection or tuberculosis that may require treatment.

In addition, autoimmune disorders such as Graves’ disease, Guillain-Barre and polymyositis have occurred in patients.

Lactic Acidosis

Though rare, some patients who used the ingredients in Truvada alone or in combination with other antiretrovirals have experienced lactic acidosis — buildup of acid in the blood — and severe hepatomegaly with steatosis, or enlarged liver. Some of these were fatal.

In one case reported in Nation Journal of Medical Research by Chirag M. Chhatwani and colleagues, a 50-year-old man with HIV switched to tenofovir, lamivudine and efavrienz. After three days on this combination, he experienced nausea, vomiting, upper abdominal pain and breathlessness.

Doctors diagnosed him with lactic acidosis and hepatitis induced by tenofovir. He improved after stopping the drug.

It can also affect people with HBV. In the case reported by Dr. Tae Yang Jung and colleagues in the journal Medicine, a 59-year-old man with HBV developed lactic acidosis after ten days on TDF. Despite stopping TDF and starting hemodialysis, the patient died.

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

17 Cited Research Articles

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