Medical Editor: John P. Cunha, DO, FACOEP
What Is Viread?
Viread (tenofovir disoproxil fumarate) is an antiretroviral drug that is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Viread is also used to treat chronic hepatitis B.
What Are Side Effects of Viread?
Common side effects of Viread include:
- nausea,
- stomach pain,
- diarrhea,
- depression,
- headache,
- dizziness,
- weakness,
- trouble sleeping,
- itching or rash, or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
Tell your doctor if you have unlikely but serious side effects of Viread including:
- mental/mood changes (such as depression, anxiety, confusion).
Tell your doctor if you have rare but serious side effects of Viread including:
- signs of kidney problems (such as a change in the amount of urine), or
- unusual thirst.
Dosage for Viread
The dose is one 300 mg Viread Tablet once daily taken orally, without regard to food.
What Drugs, Substances, or Supplements Interact with Viread?
Viread may interact with other HIV or AIDS medications, lithium, methotrexate, pain or arthritis medicines, medicines used to treat ulcerative colitis, medicines used to prevent organ transplant rejection, IV antibiotics, antiviral medicines, or injectable medications to treat osteoporosis or Paget's disease of the bones. Tell your doctor all medications and supplements you use.
Viread During Pregnancy and Breastfeeding
This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. You should not breastfeed while you are using Viread. Women with HIV or AIDS should not breastfeed at all.
Additional Information
Our Viread (tenofovir disoproxil fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
A Timeline of the HIV/AIDS Pandemic See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.
Call your doctor at once if you have:
- sore throat, flu symptoms, easy bruising or unusual bleeding;
- kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
- liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Tenofovir can affect your immune system (even weeks or months after you've used this medicine). Tell your doctor if you have:
- signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
- trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
- swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
Common side effects may include:
- stomach pain, nausea, vomiting, diarrhea;
- fever, pain;
- weakness, dizziness;
- headache;
- depressed mood;
- itching, rash; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
What is HIV? See AnswerSIDE EFFECTS
The following adverse reactions are discussed in other sections of the labeling:
- Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection [see WARNINGS AND PRECAUTIONS].
- New Onset or Worsening Renal Impairment [see WARNINGS AND PRECAUTIONS].
- Immune Reconstitution Syndrome [see WARNINGS AND PRECAUTIONS].
- Bone Loss and Mineralization Defects [see WARNINGS AND PRECAUTIONS].
- Lactic Acidosis/Severe Hepatomegaly with Steatosis [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
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.
Adverse Reactions From Clinical Trials Experience In HIV-1 Infected Adults
More than 12,000 subjects have been treated with VIREAD alone or in combination with other antiretroviral medicinal products for periods of 28 days to 215 weeks in clinical trials and expanded access programs. A total of 1,544 subjects have received VIREAD 300 mg once daily in clinical trials; over 11,000 subjects have received VIREAD in expanded access programs.
The most common adverse reactions (incidence greater than or equal to 10%, Grades 2-4) identified from any of the 3 large controlled clinical trials include rash, diarrhea, headache, pain, depression, asthenia, and nausea.
Clinical Trials In Treatment-Naive HIV-1 Infected Adult Subjects
In Trial 903, 600 antiretroviral-naive subjects received VIREAD (N=299) or stavudine (d4T) (N=301) administered in combination with lamivudine (3TC) and efavirenz (EFV) for 144 weeks. The most common adverse reactions were mild to moderate gastrointestinal events and dizziness. Mild adverse reactions (Grade 1) were common with a similar incidence in both arms and included dizziness, diarrhea, and nausea. Table 4 provides the treatment-emergent adverse reactions (Grades 2- 4) occurring in greater than or equal to 5% of subjects treated in any treatment group.
Table 4 : Selected Adverse Reactions* (Grades 2-4) Reported in ≥5% in Any Treatment Group in Trial 903 (0-144 Weeks)
| VIRE AD+3T C+EF V N=299 | d4T+3TC+EFV N=301 | |
| VIRE AD+3T C+EFV N=299 | d4T+3TC+EFV N=301 | |
| Rash event† | 18% | 12% |
| Headache | 14% | 17% |
| Pain | 13% | 12% |
| Diarrhea | 11% | 13% |
| Depression | 11% | 10% |
| Back pain | 9% | 8% |
| Nausea | 8% | 9% |
| Fever | 8% | 7% |
| Abdominal pain | 7% | 12% |
| Asthenia | 6% | 7% |
| Anxiety | 6% | 6% |
| Vomiting | 5% | 9% |
| Insomnia | 5% | 8% |
| Arthralgia | 5% | 7% |
| Pneumonia | 5% | 5% |
| Dyspepsia | 4% | 5% |
| Dizziness | 3% | 6% |
| Myalgia | 3% | 5% |
| Lipodystrophy‡ | 1% | 8% |
| Peripheral neuropathy§ | 1% | 5% |
| *Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. † Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, and pustular rash. ‡Lipodystrophy represents a variety of investigator-described adverse events not a protocol-defined syndrome. §Peripheral neuropathy includes peripheral neuritis and neuropathy. | ||
Laboratory Abnormalities
Table 5 provides a list of laboratory abnormalities (Grades 3-4) observed in Trial 903. With the exception of fasting cholesterol and fasting triglyceride elevations that were more common in the d4T group (40% and 9%) compared with the VIREAD group (19% and 1%), respectively, laboratory abnormalities observed in this trial occurred with similar frequency in the VIREAD and d4T treatment arms.
Table 5 : Grades 3-4 Laboratory Abnormalities Reported in ≥1% of VIREAD-Treated Subjects in Trial 903 (0-144 Weeks)
| VIREAD+3TC+EFV N=299 | d4T+3TC+EFV N=301 | |
| Any ≥ Grade 3 Laboratory Abnormality | 36% | 42% |
| Fasting Cholesterol (>240 mg/dL) | 19% | 40% |
| Creatine Kinase (M: >990 U/L; F: >845 U/L) | 12% | 12% |
| Serum Amylase (>175 LI/L) | 9% | 8% |
| AST (M: >180 U/L; F: >170 U/L) | 5% | 7% |
| ALT (M: >215 U/L; F: >170 U/L) | 4% | 5% |
| Hematuria (>100 RBC/HPF) | 7% | 7% |
| Neutrophils (<750/mm³) | 3% | 1% |
| Fasting Triglycerides (>750 mg/dL) | 1% | 9% |
Changes In Bone Mineral Density
In HIV-1 infected adult subjects in Trial 903, there was a significantly greater mean percentage decrease from baseline in BMD at the lumbar spine in subjects receiving VIREAD + 3TC + EFV (-2.2% ± 3.9) compared with subjects receiving d4T + 3TC + EFV (-1.0% ± 4.6) through 144 weeks. Changes in BMD at the hip were similar between the two treatment groups (-2.8% ± 3.5 in the VIREAD group vs. -2.4% ± 4.5 in the d4T group). In both groups, the majority of the reduction in BMD occurred in the first 24-48 weeks of the trial and this reduction was sustained through Week 144. Twenty-eight percent of VIREADtreated subjects vs. 21% of d4T-treated subjects lost at least 5% of BMD at the spine or 7% of BMD at the hip. Clinically relevant fractures (excluding fingers and toes) were reported in 4 subjects in the VIREAD group and 6 subjects in the d4T group. In addition, there were significant increases in biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C telopeptide, and urinary N telopeptide) and higher serum parathyroid hormone levels and 1,25 Vitamin D levels in the VIREAD group relative to the d4T group; however, except for bone-specific alkaline phosphatase, these changes resulted in values that remained within the normal range [see WARNINGS AND PRECAUTIONS].
In Trial 934, 511 antiretroviral-naive subjects received efavirenz (EFV) administered in combination with either emtricitabine (FTC) + VIREAD (N=257) or zidovudine (AZT)/lamivudine (3TC) (N=254) for 144 weeks. The most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Table 6 provides the treatment-emergent adverse reactions (Grades 2-4) occurring in greater than or equal to 5% of subjects treated in any treatment group.
Table 6 : Selected Adverse Reactions (Grades 2-4) Reported in ≥5% in Any Treatment Group in Trial 934 (0-144 Weeks)
| VIREAD†+FTC+EFV N=257 | AZT/3TC+EFV N=254 | |
| Fatigue | 9% | 8% |
| Depression | 9% | 7% |
| Nausea | 9% | 7% |
| Diarrhea | 9% | 5% |
| Dizziness | 8% | 7% |
| Upper respiratory tract infections | 8% | 5% |
| Sinusitis | 8% | 4% |
| Rash event‡ | 7% | 9% |
| Headache | 6% | 5% |
| Insomnia | 5% | 7% |
| Nasopharyngitis | 5% | 3% |
| Vomiting | 2% | 5% |
| *Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. †From Weeks 96 to 144 of the trial, subjects received TRUVADA with EFV in place of VIREAD ® + FTC with EFV. ‡Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculopapular, rash pruritic, and rash vesicular. Laboratory Abnormalities | ||
Laboratory abnormalities observed in this trial were generally consistent with those seen in previous trials (Table 7).
Table 7 : Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Trial 934 (0- 144 Weeks)
| VIREAD + FTC + EFV* N=257 | AZT/3TC + EFV N=254 | |
| Aliy ≥ 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 LI/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% |
| *From Weeks 96 to 144 of the trial, subjects received TRUVADA with EFV in place of VIREAD + FTC with EFV. | ||
Clinical Trials In Treatment-Experienced HIV-1 Infected Adult Subjects
In Trial 907, the adverse reactions seen in HIV-1 infected treatment-experienced subjects were generally consistent with those seen in treatment-naive subjects, including mild to moderate gastrointestinal events, such as nausea, diarrhea, vomiting, and flatulence. Less than 1% of subjects discontinued participation in the clinical trials due to gastrointestinal adverse reactions. Table 8 provides the treatment-emergent adverse reactions (Grades 2-4) occurring in greater than or equal to 3% of subjects treated in any treatment group.
Table 8 : Selected Adverse Reactions (Grades 2-4) Reported in ≥3% in Any Treatment Group in Trial 907 (0-48 Weeks)
| VIREAD N=368 (Week 0-24) | Placebo N=182 (Week 0-24) | VIREAD N=368 (Week 0-48) | Placebo Crossover to VIREAD N=170 (Week 24-48) | |
| Body as a Whole | ||||
| Asthenia | 7% | 6% | 11% | 1% |
| Pain | 7% | 7% | 12% | 4% |
| Headache | 5% | 5% | 8% | 2% |
| Abdominal pain | 4% | 3% | 7% | 6% |
| Back pain | 3% | 3% | 4% | 2% |
| Chest pain | 3% | 1% | 3% | 2% |
| Fever | 2% | 2% | 4% | 2% |
| Digestive System | ||||
| Diarrhea | 11% | 10% | 16% | 11% |
| Nausea | 8% | 5% | 11% | 7% |
| Vomiting | 4% | 1% | 7% | 5% |
| Anorexia | 3% | 2% | 4% | 1% |
| Dyspepsia | 3% | 2% | 4% | 2% |
| Flatulence | 3% | 1% | 4% | 1% |
| Respiratory | ||||
| Pneumonia | 2% | 0% | 3% | 2% |
| Nervous System | ||||
| Depression | 4% | 3% | 8% | 4% |
| Insomnia | 3% | 2% | 4% | 4% |
| Peripheral neuropathy† | 3% | 3% | 5% | 2% |
| Dizziness | 1% | 3% | 3% | 1% |
| Skin and Appendage | ||||
| Rash event‡ | 5% | 4% | 7% | 1% |
| Sweating | 3% | 2% | 3% | 1% |
| Musculoskeletal | ||||
| Myalgia | 3% | 3% | 4% | 1% |
| Metabolic | ||||
| Weight loss | 2% | 1% | 4% | 2% |
| * Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. †Peripheral neuropathy includes peripheral neuritis and neuropathy. ‡Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, and pustular rash. | ||||
Laboratory Abnormalities
Table 9 provides a list of Grade 3-4 laboratory abnormalities observed in Trial 907. Laboratory abnormalities occurred with similar frequency in the VIREAD and placebo groups.
Table 9 : Grades 3-4 Laboratory Abnormalities Reported in ≥1% of VIREAD-Treated Subjects in Trial 907 (0-48 Weeks)
| VIREAD N=368 (Week 0-24) | Placebo N=182 (Week 0-24) | VIREAD N=368 (Week 0-18) | Placebo Crossover to VIREAD N=170 (Week 24-48) | |
| Any ≥ Grade 3 Laboratory Abnormality | 25% | 38% | 35% | 34% |
| Triglycerides (>750 mg/dL) | 8% | 13% | 11% | 9% |
| Creatine Kinase (M: >990 U/L; F: >845 U/L) | 7% | 14% | 12% | 12% |
| Serum Amylase (>175 LI/L) | 6% | 7% | 7% | 6% |
| Glycosuria (≥3+) | 3% | 3% | 3% | 2% |
| AST (M: >180 U/L; F: >170 U/L) | 3% | 3% | 4% | 5% |
| ALT (M: >215 U/L; F: >170 U/L) | 2% | 2% | 4% | 5% |
| Serum Glucose (>250 LI/L) | 2% | 4% | 3% | 3% |
| Neutrophils (<750/mm³) | 1% | 1% | 2% | 1% |
Adverse Reactions From Clinical Trials Experience In HIV-1 Infected Pediatric Subjects 2 Years And Older
Assessment of adverse reactions is based on two randomized trials (Trials 352 and 321) in 184 HIV-1 infected pediatric subjects (2 years to less than 18 years of age) who received treatment with VIREAD (N=93) or placebo/active comparator (N=91) in combination with other antiretroviral agents for 48 weeks [see Clinical Studies]. The adverse reactions observed in subjects who received treatment with VIREAD were consistent with those observed in clinical trials in adults.
In Trial 352, 89 pediatric subjects (2 years to less than 12 years of age) received VIREAD for a median exposure of 104 weeks. Of these, 4 subjects discontinued from the trial due to adverse reactions consistent with proximal renal tubulopathy. Three of these 4 subjects presented with hypophosphatemia and also had decreases in total body or spine BMD Z-score [see WARNINGS AND PRECAUTIONS].
Changes In Bone Mineral Density
In Trial 321 (12 years to less than 18 years of age), the mean rate of BMD gain at Week 48 was less in the VIREAD group compared to the placebo group. Six VIREAD-treated subjects and one placebo-treated subject had significant (greater than 4%) lumbar spine BMD loss at Week 48. Changes from baseline BMD Z-scores were -0.341 for lumbar spine and -0.458 for total body in the 28 subjects who were treated with VIREAD for 96 weeks. In Trial 352 (2 years to less than 12 years of age), the mean rate of BMD gain in lumbar spine at Week 48 was similar between the VIREAD and the d4T or AZT treatment groups. Total body BMD gain was less in the VIREAD group compared to the d4T or AZT treatment group. One VIREAD-treated subject and none of the d4T- or AZT-treated subjects experienced significant (greater than 4%) lumbar spine BMD loss at Week 48. Changes from baseline in BMD Z-scores were -0.012 for lumbar spine and -0.338 for total body in the 64 subjects who were treated with VIREAD for 96 weeks. In both trials, skeletal growth (height) appeared to be unaffected for the duration of the clinical trials [see WARNINGS AND PRECAUTIONS].
Adverse Reactions From Clinical Trials Experience In HBV-Infected Adults
Clinical Trials In Adult Subjects With Chronic Hepatitis B And Compensated Liver Disease
In controlled clinical trials in 641 subjects with chronic hepatitis B (0102 and 0103), more subjects treated with VIREAD during the 48-week double-blind period experienced nausea: 9% with VIREAD versus 2% with HEPSERA . Other treatment-emergent adverse reactions reported in more than 5% of subjects treated with VIREAD included: abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash.
In Trials 0102 and 0103, during the open-label phase of treatment with VIREAD (weeks 48-384), 2% of subjects (13/585) experienced a confirmed increase in serum creatinine of 0.5 mg/dL from baseline. No significant change in the tolerability profile was observed with continued treatment for up to 384 weeks.
Laboratory Abnormalities
Table 10 provides a list of Grade 3-4 laboratory abnormalities through Week 48. Grades 3-4 laboratory abnormalities were similar in subjects continuing VIREAD treatment for up to 384 weeks in these trials.
Table 10 : Grades 3-4 Laboratory Abnormalities Reported in ≥1% of VIREAD-Treated Subjects in Trials 0102 and 0103 (0-48 Weeks)
| VIREAD N=426 | HEPSERA N=215 | |
| Aliy ≥ Grade 3 Laboratory Abnormality | 19% | 13% |
| Creatine Kinase (M: >990 U/L; F: >845 U/L) | 2% | 3% |
| Serum Amylase (>175 LI/L) | 4% | 1% |
| Glycosuria (≥3+) | 3% | <1% |
| AST (M: >180 U/L; F: >170 U/L) | 4% | 4% |
| ALT (M: >215 U/L; F: >170 U/L) | 10% | 6% |
The overall incidence of on-treatment ALT flares (defined as serum ALT greater than 2 x baseline and greater than 10 x ULN, with or without associated symptoms) was similar between VIREAD (2.6%) and HEPSERA (2%). ALT flares generally occurred within the first 4 to 8 weeks of treatment and were accompanied by decreases in HBV DNA levels. No subject had evidence of decompensation. ALT flares typically resolved within 4 to 8 weeks without changes in study medication.
The adverse reactions observed in subjects with chronic hepatitis B and lamivudine resistance who received treatment with VIREAD were consistent with those observed in other HBV clinical trials in adults.
Clinical Trials In Adult Subjects With Chronic Hepatitis B And Decompensated Liver Disease
In Trial 0108, a small randomized, double-blind, active-controlled trial, subjects with chronic HBV and decompensated liver disease received treatment with VIREAD or other antiviral drugs for up to 48 weeks [see Clinical Studies]. Among the 45 subjects receiving VIREAD, the most frequently reported treatment-emergent adverse reactions of any severity were abdominal pain (22%), nausea (20%), insomnia (18%), pruritus (16%), vomiting (13%), dizziness (13%), and pyrexia (11%). Two of 45 (4%) subjects died through Week 48 of the trial due to progression of liver disease. Three of 45 (7%) subjects discontinued treatment due to an adverse event. Four of 45 (9%) subjects experienced a confirmed increase in serum creatinine of 0.5 mg/dL (1 subject also had a confirmed serum phosphorus less than 2 mg/Dl through Week 48). Three of these subjects (each of whom had a Child-Pugh score greater than or equal to 10 and MELD score greater than or equal to 14 at entry) developed renal failure. Because both VIREAD and decompensated liver disease may have an impact on renal function, the contribution of VIREAD to renal impairment in this population is difficult to ascertain.
One of 45 subjects experienced an on-treatment hepatic flare during the 48-week trial.
Adverse Reactions From Clinical Trials Experience In HBV-Infected Pediatric Subjects 2 Years And Older
Assessment of adverse reactions in pediatric subjects infected with chronic HBV is based on two randomized trials: Trial GS-US-174-0115 in 106 subjects (12 years to less than 18 years of age) receiving treatment with VIREAD (N=52) or placebo (N=54) for 72 weeks and Trial GS-US-174-0144 in 89 subjects (2 years to less than 12 years of age) receiving treatment with VIREAD (N=60) or placebo (N=29) for 48 weeks [see Clinical Studies]. The adverse reactions observed in pediatric subjects who received treatment with VIREAD were consistent with those observed in clinical trials of VIREAD in adults.
In Trial 115 (12 years to less than 18 years of age) and Trial 144 (2 years to less than 12 years of age), both the VIREAD and placebo treatment arms experienced an overall increase in mean lumbar spine and total body BMD over 72 and 48 weeks, respectively, as expected for a pediatric population (Table 11). In Trial 115, the mean percentage BMD gains from baseline to Week 72 in lumbar spine and total body BMD in VIREAD-treated subjects were less than the mean percentage BMD gains observed in placebo-treated subjects (Table 11).Three subjects (6%) in the VIREAD group and two subjects (4%) in the placebo group had significant (greater than or equal to 4%) lumbar spine BMD loss at Week 72. In Trial 144 (2 years to less than 12 years of age), mean percentage BMD gains from baseline to Week 48 in lumbar spine and total body BMD in VIREAD-treated subjects were less than the mean percentage BMD gains observed in placebo-treated subjects. At Week 48, the cumulative percentage of subjects with greater than or equal to 4% decreases in spine or whole body BMD was numerically higher for subjects in the TDF group compared with the placebo group (Table 11). As observed in pediatric studies of HIV-infected subjects, normal skeletal growth (height) was not affected for the duration of the clinical trial [see WARNINGS AND PRECAUTIONS].
Table 11 : Change in Bone Mineral Density from Baseline in Pediatric Subjects 2 Years to <12 Years of Age (Trials 115 and 144)
| Trial 115 (Week 72) | Trial 144 (Week 48) | |||
| VIREAD (N=52) | Placebo (N=54) | VIREAD (N=60) | Placebo (N=29) | |
| Mean percentage change in BMD | ||||
| Lumbar spine | +5% | +8% | +4% | +8% |
| Total body | +3% | +5% | +5% | +9% |
| Cumulative incidence of ≥4% decrease in BMD | ||||
| Lumbar spine | 6% | 4% | 18% | 7% |
| Total body | 0% | 2% | 7% | 0% |
| Baseline BMD Z-score (mean) | ||||
| Lumbar spine | -0.43 | -0.28 | +0.02 | -0.29 |
| Total body | -0.20 | -0.26 | +0.11 | -0.05 |
| Mean change in BMD Z-score | ||||
| Lumbar spine | -0.05 | +0.07 | -0.12 | +0.14 |
| Total body | -0.15 | +0.06 | -0.18 | +0.22 |
The effects of VIREAD-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in pediatric patients 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of longduration exposure in younger children is unknown [see WARNINGS AND PRECAUTIONS].
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of VIREAD. Because postmarketing 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.
Immune System Disorders
allergic reaction, including angioedema
Metabolism And Nutrition Disorders
lactic acidosis, hypokalemia, hypophosphatemia
Respiratory, Thoracic, And Mediastinal Disorders
Gastrointestinal Disorders
pancreatitis, increased amylase, abdominal pain
Hepatobiliary Disorders
hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)
Skin And Subcutaneous Tissue Disorders
rash
Musculoskeletal And Connective Tissue Disorders
rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
Renal And Urinary Disorders
acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
General Disorders And Administration Site Conditions
asthenia
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.
Read the entire FDA prescribing information for Viread (Tenofovir Disoproxil Fumarate)
© Viread Patient Information is supplied by Cerner Multum, Inc. and Viread Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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