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Indinavir Side Effects

In Summary

Commonly reported side effects of indinavir include: nephrolithiasis and urolithiasis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to indinavir: oral capsule

Along with its needed effects, indinavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking indinavir:

More Common

  • Blood in the urine
  • sharp back pain just below the ribs

Less Common

  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • fever
  • headache
  • itching
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin

Rare

  • Confusion
  • dehydration
  • dry or itchy skin
  • fruity mouth odor
  • increased hunger
  • increased thirst
  • increased urination
  • pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight loss

Some side effects of indinavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Change in sense of taste
  • diarrhea
  • difficulty with sleeping
  • generalized weakness

Less Common

  • Acid or sour stomach
  • acid regurgitation
  • belching
  • cough
  • general feeling of discomfort or illness
  • heartburn
  • increase in appetite
  • indigestion
  • sleepiness

For Healthcare Professionals

Applies to indinavir: oral capsule, oral tablet

Gastrointestinal

Very common (10% or more): Nausea (up to 35.3%), diarrhea (up to 24.6%), vomiting (up to 17.8%), abdominal pain (up to 16.6%), dyspepsia

Common (1% to 10%): Acid regurgitation, increased serum amylase, flatulence, dry mouth

Frequency not reported: Aphthous stomatitis, cheilitis, constipation, eructation, gastritis, gingivitis, glossodynia, gingival hemorrhage, infectious gastroenteritis, taste disorder, dry lips

Postmarketing reports: Pancreatitis, abdominal distention, oral paresthesia[Ref]

Increased serum amylase (greater than 200% the upper limit of normal [200% ULN]) has been reported in up to 2.1% of patients.[Ref]

Nervous system

Very common (10% or more): Headache (up to 25.2%), taste perversion (up to 19.1%), dizziness (up to 10.7%)

Common (1% to 10%): Somnolence, hypoesthesia, paresthesia

Frequency not reported: Dysesthesia, fasciculation, neuralgia, peripheral neuropathy, tremor, vertigo, epidural lipomatosis, sensory loss, syncope, peripheral paresthesia

Postmarketing reports: Cerebrovascular disorder[Ref]

Other

Very common (10% or more): Asthenia/fatigue (up to 24.3%)

Common (1% to 10%): Fever, malaise

Frequency not reported: Edema/swelling, weight gain, chest pain, chills, influenza-like illness, fungal infection, pain, flushing, angiolipomatosis

Postmarketing reports: Increased serum triglycerides, increased serum cholesterol[Ref]

Dermatologic

Very common (10% or more): Rash (up to 19.1%), dry skin (up to 16.2%)

Common (1% to 10%): Pruritus

Frequency not reported: Body odor, contact dermatitis, dermatitis, folliculitis, herpes simplex, herpes zoster, night sweats, seborrhea, skin disorder, skin infection, sweating, leukocytoclastic vasculitis

Postmarketing reports: Rash (including Stevens-Johnson syndrome, erythema multiforme), hypersensitivity vasculitis, hyperpigmentation, ingrown toenails, paronychia, urticaria, alopecia[Ref]

Hepatic

Asymptomatic hyperbilirubinemia (total bilirubin at least 2.5 mg/dL [43 mcmol/L]) has been reported in about 14% of patients, primarily as elevated indirect bilirubin; this was associated with elevated ALT, AST, or alkaline phosphatase in less than 1% of patients. Most patients continued therapy without dose reduction and bilirubin values gradually declined towards baseline. Hyperbilirubinemia was reported more often at doses greater than 2.4 g/day compared to doses up to 2.4 g/day.

Increased total serum bilirubin (greater than 250% ULN), ALT (greater than 500% ULN), and AST (greater than 500% ULN) have been reported in up to 11.9%, up to 4.9%, and up to 3.7% of patients, respectively.[Ref]

Very common (10% or more): Asymptomatic hyperbilirubinemia (primarily as elevated indirect bilirubin; about 14%), increased total serum bilirubin (up to 11.9%), increased ALT, increased AST

Common (1% to 10%): Jaundice

Frequency not reported: Cholecystitis, cholestasis, hepatic cytolysis, liver cirrhosis

Postmarketing reports: Hepatitis, hepatic failure, liver function abnormalities[Ref]

Renal

Very common (10% or more): Nephrolithiasis/urolithiasis (including flank pain with or without hematuria [including microscopic hematuria]; about 12.4%)

Common (1% to 10%): Flank pain, hydronephrosis, stent placement required

Uncommon (0.1% to 1%): Increased creatinine

Frequency not reported: Papillary necrosis

Postmarketing reports: Nephrolithiasis/urolithiasis (sometimes resulted in renal insufficiency, acute renal failure, pyelonephritis with or without bacteremia), interstitial nephritis (occasionally with indinavir crystal deposits), renal insufficiency, renal failure[Ref]

The cumulative frequency of nephrolithiasis events increased with duration of drug exposure; however, risk over time remained relatively constant. Of patients who developed nephrolithiasis/urolithiasis in clinical trials, 7 of 246 developed hydronephrosis and 11 of 246 underwent stent placement; after the acute episode, 12 of 246 patients discontinued therapy. In general, nephrolithiasis (including flank pain with or without hematuria [including microscopic hematuria]) was not associated with renal dysfunction and resolved with hydration and temporary interruption of therapy (e.g., 1 to 3 days). Nephrolithiasis/urolithiasis was reported more often at doses greater than 2.4 g/day compared to doses up to 2.4 g/day.

Increased creatinine (greater than 300% ULN) has been reported in up to 0.2% of patients.

During postmarketing experience, interstitial nephritis did not resolve after some patients stopped this drug.[Ref]

Genitourinary

Drug-induced neuropathy has resulted in erectile dysfunction.[Ref]

Very common (10% or more): Hematuria, proteinuria, crystalluria

Common (1% to 10%): Dysuria

Frequency not reported: Nocturia, premenstrual syndrome, pyuria, renal colic, urinary frequency, urinary tract infection, urine abnormality, urine sediment abnormality, erectile dysfunction

Postmarketing reports: Leukocyturia[Ref]

Hematologic

Decreased neutrophils (less than 750/mm3), hemoglobin (less than 7 g/dL), and platelet count (less than 50,000/mm3) have been reported in up to 5.1%, up to 2.4%, and up to 0.9% of patients, respectively.[Ref]

Very common (10% or more): Increased mean cell volume, decreased neutrophils

Common (1% to 10%): Decreased hemoglobin, anemia

Uncommon (0.1% to 1%): Decreased platelet count

Frequency not reported: Increased platelets, lymphadenopathy, spleen disorder, hemolytic anemia

Postmarketing reports: Increased spontaneous bleeding in hemophiliacs, thrombocytopenia, anemia including acute hemolytic anemia[Ref]

Metabolic

Increased glucose (greater than 250 mg/dL) has been reported in up to 1.6% of patients.[Ref]

Common (1% to 10%): Anorexia, increased appetite, increased glucose

Frequency not reported: Insulin resistance

Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), new-onset diabetes mellitus, hyperglycemia, exacerbation of preexisting diabetes mellitus, hypertriglyceridemia, hypercholesterolemia[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Agitation, bruxism, dream abnormality, anxiety, anxiety disorder, decreased mental acuity, excitement, nervousness, neurotic disorder, sleep disorder, neurosis

Postmarketing reports: Depression[Ref]

Musculoskeletal

Drug deposition in synovial fluid may have resulted in monoarthritis in a patient. Intraarticular drug levels of 1.36 mcg/mL were measured in the patient's knee joint.[Ref]

Common (1% to 10%): Back pain, myalgia

Frequency not reported: Leg pain, acute monoarthritis, enthesopathies, adhesive capsulitis, muscle cramps, muscle weakness, stiffness, musculoskeletal pain, shoulder pain

Postmarketing reports: Arthralgia, periarthritis, myositis, rhabdomyolysis, increased creatine phosphokinase, osteonecrosis[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea/difficulty breathing/shortness of breath, upper respiratory infections, pharyngitis

Frequency not reported: Halitosis, pharyngeal hyperemia, pneumonia, rales/rhonchi, respiratory failure, sinus disorder, sinusitis, respiratory distress[Ref]

Hypersensitivity

Frequency not reported: Food allergy

Postmarketing reports: Anaphylactoid reactions, urticaria, vasculitis[Ref]

Cardiovascular

Frequency not reported: Hypertension, palpitation

Postmarketing reports: Cardiovascular disorders (including myocardial infarction, angina pectoris)[Ref]

Immunologic

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

Ocular

Frequency not reported: Accommodation disorder, blurred vision, eye pain, eye swelling, orbital edema[Ref]

Endocrine

Frequency not reported: Galactorrhea, hyperprolactinemia[Ref]

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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