Indinavir Side Effects

Some side effects of indinavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to indinavir: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking indinavir: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indinavir and call your doctor at once if you have any of these serious side effects:

• pain in your side or lower back, blood in your urine;

• pale skin, easy bruising or bleeding, confusion or weakness;

• signs of a new infection, such as fever or chills, cough, or flu symptoms;

• rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• muscle weakness, tired feeling, joint or muscle pain, feeling short of breath;

• weakness or prickly feeling in your fingers or toes;

• problems with walking, breathing, speech, swallowing, or eye movement;

• severe lower back pain, loss of bladder or bowel control;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• high blood sugar -- increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of indinavir may include:

• mild nausea, vomiting;

• numbness or tingling, especially around your mouth;

• headache, mood changes; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to indinavir: oral capsule, oral tablet

Renal

Renal side effects have included nephrolithiasis/urolithiasis, characterized by renal colic and flank pain with or without hematuria, in 12.4% (ranging from 4.7% to 34.4% in individual studies) of patients receiving indinavir at the usual dose during clinical trials; 2.8% of these developed hydronephrosis and 4.5% underwent stent placements. Increased creatinine greater than 3 times ULN occurred in 0.2% of patients receiving indinavir combined with zidovudine plus lamivudine. Capillary necrosis and pyuria have also been reported. Nephrolithiasis/urolithiasis (sometimes resulting in renal insufficiency or acute renal failure), interstitial nephritis (occasionally with indinavir crystal deposits), pyelonephritis (with or without bacteremia), renal insufficiency, and renal failure have been reported during postmarketing experience.

The incidence of nephrolithiasis/urolithiasis is increased with doses greater than 2.4 g/day.

According to the manufacturer, indinavir was identified as a component of the kidney stones from 8 of 12 patients in whom nephrolithiasis developed. It is not known whether an additional risk is incurred with the concomitant use of crystalluria-inducing medications such as sulfonamides.

During postmarketing experience, the interstitial nephritis continued in some patients after stopping indinavir.

Hepatic

Hepatic side effects have included asymptomatic hyperbilirubinemia (total bilirubin greater than or equal to 2.5 mg/dL) in 14% of patients and frequency was increased at doses greater than 2.4 g/day. Less than 1% of these patients had concomitant elevations in ALT or AST. Elevated ALT greater than 5 times ULN (5%), AST greater than 5 times ULN (3.7%), total serum bilirubin greater than 2.5 times ULN (11.9%), and serum amylase greater than 2 times ULN (2.1%) have also been reported. Hepatitis, hepatic failure, hepatic cytolysis, pancreatitis (including at least one case with lactic acidosis), jaundice, liver function abnormalities, increased serum triglycerides, and cirrhosis have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (12%), diarrhea (3.3%), vomiting (8.4%), acid regurgitation (3%), anorexia (3%), increased appetite (2.1%), dyspepsia (1.5%), jaundice (1.5%), and dry mouth/lips. Nausea and vomiting may increase substantially (up to 32%) when combined with zidovudine and other nucleoside analog reverse transcriptase inhibitors. Abdominal distention and dyspepsia have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (1.2%), pruritus (4.2%), dry skin, and leukocytoclastic vasculitis. Rash (including Stevens-Johnson syndrome and erythema multiforme), nail and skin hyperpigmentation, ingrown toenails and/or paronychia, pruritus, and alopecia have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included nephrolithiasis/urolithiasis (including renal colic and flank pain with and without hematuria; 8.7%), dysuria (1.5%), hematuria, nocturia, proteinuria, urinary frequency, and urinary tract infection. Indinavir-induced neuropathy may result in erectile dysfunction. Leukocyturia, crystalluria, and dysuria have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreased hemoglobin (0.6%), anemia, (0.6%), decreased platelets (0.9%), decreased neutrophils (2.4%), and increased platelets. Lymphadenopathy, spleen disorder, and hemolytic anemia have also been reported but rarely. Increased spontaneous bleeding in hemophiliacs and acute hemolytic anemia have been reported during postmarketing experience.

Cases of acute spontaneous bleeding in hemophiliacs may be associated with protease inhibitors in general.

Metabolic

Metabolic side effects have included increased blood glucose (0.9%) and insulin resistance. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors, including indinavir; however, a causal relationship has not been established. New-onset diabetes mellitus, hyperglycemia, exacerbation of existing diabetes, and increased serum cholesterol have been reported during postmarketing experience.

In a 1997 postmarketing report, the average time to onset of protease inhibitor (PI)-related hyperglycemic event was 76 days. However, some cases occurred as early as 4 days after the initiation of therapy. The disorder was serious in 32 out of 83 cases, which included 27 hospitalizations and 5 incidents of diabetic ketoacidosis.

The underlying mechanism for the development of PI-related hyperglycemia has not been identified. It has been proposed that since PIs are peptidomimetic inhibitors, they may inhibit the conversion of proinsulin to insulin via the calcium-dependent endopeptidases. Peripheral insulin resistance may be involved, since impaired glucose tolerance has been reported in PI-treated subjects in one study. Patients receiving PI therapy should have blood glucose levels measured periodically.

Musculoskeletal

Indinavir deposition in synovial fluid may have resulted in monoarthritis in a patient. Intraarticular indinavir levels of 1.36 mcg/mL were measured in the patient's knee joint.

Musculoskeletal side effects have included back pain (8.4%), acute monoarthritis, enthesopathies, adhesive capsulitis, myalgia, muscle cramps, muscle weakness, stiffness, and muscle pain. Arthralgia has been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (5.4%), dizziness (3%), and somnolence (2.4%). Agitation, bruxism, dream abnormality, dysesthesia, fasciculation, hypesthesia, neuralgia, peripheral neuropathy, tremor, vertigo, epidural lipomatosis, sensory loss, syncope, and peripheral paresthesia have also been reported. Oral paresthesia has been reported during postmarketing experience.

Respiratory

Respiratory side effects have included cough (1.5%), dyspnea, halitosis, pharyngitis, rales/rhonchi, respiratory distress, and upper respiratory infections.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Cardiovascular

Cardiovascular side effects have included myocardial infarction, angina pectoris, hypertension, and cerebrovascular disorder during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions, urticaria, and vasculitis during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety and neurosis. Depression has been reported during postmarketing experience.

Other

Other side effects have included abdominal pain (17%), taste perversion (2.7%), asthenia/fatigue (2.1%), fever (1.5%), and malaise (2.1%). Angiolipomatosis has been reported during postmarketing experience.

Ocular

Ocular side effects have included blurred vision, eye pain, eye swelling, and orbital edema.

Endocrine

Endocrine side effects have included galactorrhea and hyperprolactinemia.

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