Indinavir Side Effects
Medically reviewed by Drugs.com. Last updated on Jun 3, 2023.
Applies to indinavir: oral capsule.
Serious side effects of Indinavir
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:
- Blood in the urine
- sharp back pain just below the ribs
- Abdominal or stomach pain
- clay-colored stools
- dark urine
- loss of appetite
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
- 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
- weight loss
Other side effects of Indinavir
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:
- Change in sense of taste
- difficulty with sleeping
- generalized weakness
- Acid or sour stomach
- acid regurgitation
- general feeling of discomfort or illness
- increase in appetite
For Healthcare Professionals
Applies to indinavir: oral capsule, oral tablet.
Increased serum amylase (greater than 200% the upper limit of normal [200% ULN]) has been reported in up to 2.1% of patients.[Ref]
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]
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]
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]
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
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]
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): 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]
Very common (10% or more): Hematuria, proteinuria, crystalluria
Common (1% to 10%): Dysuria
Postmarketing reports: Leukocyturia[Ref]
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
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]
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]
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]
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]
Frequency not reported: Food allergy
Postmarketing reports: Anaphylactoid reactions, urticaria, vasculitis[Ref]
Frequency not reported: Hypertension, palpitation
Frequency not reported: Accommodation disorder, blurred vision, eye pain, eye swelling, orbital edema[Ref]
Frequency not reported: Galactorrhea, hyperprolactinemia[Ref]
More about indinavir
- Check interactions
- Compare alternatives
- Reviews (1)
- Dosage information
- During pregnancy
- Drug class: protease inhibitors
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Some side effects may not be reported. You may report them to the FDA.