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Note: This document contains side effect information about indinavir. Some of the dosage forms listed on this page may not apply to the brand name Crixivan.
Common side effects of Crixivan include: nephrolithiasis and urolithiasis. See below for a comprehensive list of adverse effects.
Applies to indinavir: oral capsule
Along with its needed effects, indinavir (the active ingredient contained in Crixivan) 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:
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:
Applies to indinavir: oral capsule, oral tablet
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
Increased serum amylase (greater than 200% the upper limit of normal [200% ULN]) has been reported in up to 2.1% of patients.
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
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
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
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.
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
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 (the active ingredient contained in Crixivan) crystal deposits), renal insufficiency, renal failure
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.
Drug-induced neuropathy has resulted in erectile dysfunction.
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
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.
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
Increased glucose (greater than 250 mg/dL) has been reported in up to 1.6% of patients.
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
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
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.
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
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
Frequency not reported: Food allergy
Postmarketing reports: Anaphylactoid reactions, urticaria, vasculitis
Frequency not reported: Hypertension, palpitation
Postmarketing reports: Cardiovascular disorders (including myocardial infarction, angina pectoris)
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
Frequency not reported: Accommodation disorder, blurred vision, eye pain, eye swelling, orbital edema
Frequency not reported: Galactorrhea, hyperprolactinemia
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