Tenofovir Side Effects

It is possible that some side effects of tenofovir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tenofovir: oral powder, oral tablet

As well as its needed effects, tenofovir may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tenofovir, check with your doctor immediately:

Less common
  • Chest pain
  • cough
  • fever or chills
  • tightness in the chest
  • troubled breathing
Rare
  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • unusual tiredness or weakness
Incidence not known
  • Agitation
  • bone pain
  • changes in urination
  • confusion
  • convulsions or seizures
  • depression
  • fast heartbeat
  • increased blood pressure
  • increased thirst
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • stupor
  • swelling of the face, fingers, or lower legs
  • vomiting
  • weight gain
  • yellow eyes or skin

Some tenofovir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Back pain
  • lack or loss of strength
  • pain
  • redness of the skin
  • skin rash, itching skin, hives or welts
Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • heartburn or indigestion
  • joint pain or swelling
  • muscle pains or stiffness
  • passing of gas
  • redistribution or accumulation of body fat
  • weight loss

For Healthcare Professionals

Applies to tenofovir: oral powder, oral tablet

General

The most common side effects (10% or more; Grades 2 to 4) reported during controlled clinical trials in patients with HIV-1 infection included rash, diarrhea, headache, pain, depression, asthenia, and nausea. The most common side effects associated with tenofovir in combination with other antiretrovirals have included mild to moderate gastrointestinal events (such as nausea, diarrhea, vomiting, and flatulence) in therapy-experienced patients and mild to moderate gastrointestinal events and dizziness in therapy-naive patients. Less than 1% of patients in clinical trials discontinued therapy due to gastrointestinal side effects.

The most common side effects (greater than 5%) reported during controlled clinical trials in patients with chronic hepatitis B and compensated liver disease included nausea, abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash. In patients with chronic hepatitis B and decompensated liver disease, the most common side effects reported during a controlled trial included abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia.

Gastrointestinal

Abdominal pain (any severity: 22%), nausea (any severity: 20%), and vomiting (any severity: 13%) have been in patients with chronic hepatitis B and decompensated liver disease (n=45).

Very common (10% or more): Abdominal pain (any severity: 22%), nausea (any severity: 20%), diarrhea (Grades 2 to 4: up to 16%), vomiting (any severity: 13%), nausea (Grades 2 to 4: up to 11%)
Common (1% to 10%): Vomiting (Grades 2 to 4: up to 7%), flatulence (Grades 2 to 4: up to 4%), dyspepsia (Grades 2 to 4: up to 4%), anorexia (Grades 2 to 4: up to 4%)
Postmarketing reports: Pancreatitis, abdominal pain, elevated amylase

Metabolic

Very common (10% or more): Elevated fasting cholesterol (Grade 3/4: up to 22%), elevated creatine kinase (Grade 3/4: up to 12%), elevated triglycerides (Grade 3/4: up to 11%)
Common (1% to 10%): Elevated serum amylase (Grade 3/4: up to 9%), elevated fasting triglycerides (Grade 3/4: up to 4%), weight loss (Grades 2 to 4: up to 4%), elevated serum glucose (Grade 3/4: up to 3%), elevated alkaline phosphatase (Grade 3/4: 1%), elevated serum lipase (Grade 3/4: 1%), lipodystrophy (Grades 2 to 4: 1%)
Frequency not reported: Significant increases in biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C telopeptide, urinary N telopeptide), serum phosphorus less than 2 mg/dL, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Postmarketing reports: Lactic acidosis, hypokalemia, hypophosphatemia

Serum phosphorus less than 2 mg/dL was reported in a patient with chronic hepatitis B and decompensated liver disease.

Hypokalemia and hypophosphatemia may occur due to proximal renal tubulopathy.

Dermatologic

Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash; Grades 2 to 4: up to 18%), pruritus (any severity: 16%)
Common (1% to 10%): Sweating (Grades 2 to 4: up to 3%)
Rare (less than 0.1%): Lichenoid drug eruption with eosinophilia (at least 1 case)
Postmarketing reports: Rash

Pruritus (any severity: 16%) has been reported in patients with chronic hepatitis B and decompensated liver disease (n=45).

Nervous system

Insomnia (any severity: 18%) and dizziness (any severity: 13%) were reported in patients with chronic hepatitis B and decompensated liver disease (n=45).

Very common (10% or more): Insomnia (any severity: 18%), headache (Grades 2 to 4: up to 14%), dizziness (any severity: 13%)
Common (1% to 10%): Dizziness (Grades 2 to 4: up to 8%), insomnia (Grades 2 to 4: up to 5%), peripheral neuropathy (including peripheral neuritis and neuropathy; Grades 2 to 4: up to 5%)
Frequency not reported: Somnolence, paresthesia

Other

Pyrexia (any severity: 11%) was reported in patients with chronic hepatitis B and decompensated liver disease (n=45).

Very common (10% or more): Pain (Grades 2 to 4: up to 13%), pyrexia (any severity: 11%), asthenia (Grades 2 to 4: up to 11%)
Common (1% to 10%): Fatigue (Grades 2 to 4: 9%), back pain (Grades 2 to 4: up to 9%), fever (Grades 2 to 4: up to 8%), abdominal pain (Grades 2 to 4: up to 7%), chest pain (Grades 2 to 4: up to 3%)
Frequency not reported: Higher 1,25 vitamin D levels
Postmarketing reports: Asthenia

Psychiatric

Very common (10% or more): Depression (Grades 2 to 4: up to 11%)
Common (1% to 10%): Anxiety (Grades 2 to 4: 6%)
Frequency not reported: Abnormal dreams

Hepatic

Death due to progression of liver disease has been reported in 4% of patients with chronic hepatitis B and decompensated liver disease (n=45).

On-treatment ALT or hepatic flares have been reported in patients with chronic hepatitis B.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of tenofovir.

Common (1% to 10%): Elevated alanine transaminase (ALT; Grade 3/4: up to 10%), elevated aspartate transaminase (AST; Grade 3/4: up to 5%), death due to progression of liver disease (4%)
Frequency not reported: On-treatment ALT or hepatic flares, lactic acidosis/severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis
Postmarketing reports: Hepatic steatosis, hepatitis, elevated liver enzymes (primarily AST, ALT, gamma glutamyltransferase)

Renal

Common (1% to 10%): Confirmed increase in serum creatinine of 0.5 mg/dL (9%)
Frequency not reported: New onset or worsening renal impairment, nephritis, decreased urine volume
Postmarketing reports: Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, interstitial nephritis (including acute cases)

A confirmed increase in serum creatinine of 0.5 mg/dL was reported in 9% of patients with chronic hepatitis B and decompensated liver disease (n=45); however, since tenofovir and decompensated liver disease may have an impact on renal function, the contribution of tenofovir to renal impairment in these patients is difficult to ascertain.

Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Musculoskeletal

Common (1% to 10%): Arthralgia (Grades 2 to 4: 5%), myalgia (Grades 2 to 4: up to 4%)
Rare (less than 0.1%): Clinically relevant fractures (excluding fingers and toes; at least 4 cases)
Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism
Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur due to proximal renal tubulopathy.

Respiratory

Common (1% to 10%): Sinusitis (Grades 2 to 4: 8%), upper respiratory tract infections (Grades 2 to 4: 8%), nasopharyngitis (Grades 2 to 4: 5%), pneumonia (Grades 2 to 4: up to 5%)
Frequency not reported: Nasal congestion
Postmarketing reports: Dyspnea

Hematologic

Common (1% to 10%): Decreased neutrophils (Grade 3/4: up to 3%)

Genitourinary

Common (1% to 10%): Hematuria (Grade 3/4: up to 7%), glycosuria (Grade 3/4: up to 3%)
Postmarketing reports: Proteinuria, polyuria

Endocrine

Frequency not reported: Higher serum parathyroid hormone levels

Immunologic

Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Hypersensitivity

Postmarketing reports: Allergic reaction (including angioedema)

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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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