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Crixivan

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Crixivan

Crixivan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Crixivan (indinavir sulfate) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is a type of antiviral medication called a protease inhibitor. Common side effects include stomach pain, nausea, vomiting, heartburn, loss of appetite, or headache.

The recommended dosage of Crixivan is 800 mg (usually two 400-mg capsules) orally every 8 hours. Crixivan may interact with injectable midazolam, fluticasone, St. John's wort, antibiotics, antidepressants, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, heart rhythm medications, insulin or oral diabetes medications, medicines to treat erectile dysfunction, other HIV /AIDS medicines, or seizure medications. Many other medicines can interact with Crixivan. Tell your doctor all medications you use. During pregnancy, Crixivan should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Our Crixivan (indinavir sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Crixivan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Crixivan (Indinavir Sulfate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Crixivan Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach pain, nausea, vomiting, heartburn, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: yellowing eyes/skin.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, persistent nausea/vomiting, stomach/abdominal pain, dark urine, decrease in the amount of urine.

Indinavir may cause kidney stones. Tell your doctor immediately if you have symptoms such as side or mid-back pain, pink/bloody urine, or pain with urination.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, check your blood sugar levels regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Crixivan (Indinavir Sulfate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Crixivan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials In Adults

Nephrolithiasis/urolithiasis, including flank pain with or without hematuria (including microscopic hematuria), has been reported in approximately 12.4% (301/2429; range across individual trials: 4.7% to 34.4%) of patients receiving CRIXIVAN at the recommended dose in clinical trials with a median follow-up of 47 weeks (range: 1 day to 242 weeks; 2238 patient-years follow-up). The cumulative frequency of nephrolithiasis events increases with duration of exposure to CRIXIVAN; however, the risk over time remains relatively constant. Of the patients treated with CRIXIVAN who developed nephrolithiasis/urolithiasis in clinical trials during the double-blind phase, 2.8% (7/246) were reported to develop hydronephrosis and 4.5% (11/246) underwent stent placement. Following the acute episode, 4.9% (12/246) of patients discontinued therapy. (See WARNINGS and DOSAGE AND ADMINISTRATION, Nephrolithiasis/Urolithiasis.)

Asymptomatic hyperbilirubinemia (total bilirubin ≥ 2.5 mg/dL), reported predominantly as elevated indirect bilirubin, has occurred in approximately 14% of patients treated with CRIXIVAN. In < 1% this was associated with elevations in ALT or AST.

Hyperbilirubinemia and nephrolithiasis/urolithiasis occurred more frequently at doses exceeding 2.4 g/day compared to doses ≤ 2.4 g/day.

Clinical adverse experiences reported in ≥ 2% of patients treated with CRIXIVAN alone, CRIXIVAN in combination with zidovudine or zidovudine plus lamivudine, zidovudine alone, or zidovudine plus lamivudine are presented in Table 10.

Table 10: Clinical Adverse Experiences Reported in ≥ 2% of Patients

Adverse Experience Study 028 Considered Drug-Related and of Moderate or Severe Intensity Study ACTG 320 of Unknown Drug Relationship and of Severe or Life-threatening Intensity
CRIXIVAN Percent
(n=332)
CRIXIVAN plus Zidovudine Percent
(n=332)
Zidovudine Percent
(n=332)
CRIXIVAN plus Zidovudine plus Lamivudine Percent
(n=571)
Zidovudine plus Lamivudine Percent
(n=575)
Body as a Whole
  Abdominal pain 16.6 16.0 12.0 1.9 0.7
  Asthenia/ fatigue 2.1 4.2 3.6 2.4 4.5
  Fever 1.5 1.5 2.1 3.8 3.0
  Malaise 2.1 2.7 1.8 0 0
Digestive System
  Nausea 11.7 31.9 19.6 2.8 1.4
  Diarrhea 3.3 3.0 2.4 0.9 1.2
  Vomiting 8.4 17.8 9.0 1.4 1.4
  Acid regurgitation 2.7 5.4 1.8 0.4 0
  Anorexia 2.7 5.4 3.0 0.5 0.2
  Appetite increase 2.1 1.5 1.2 0 0
  Dyspepsia 1.5 2.7 0.9 0 0
  Jaundice 1.5 2.1 0.3 0 0
Hemic and Lymphatic System
  Anemia 0.6 1.2 2.1 2.4 3.5
Musculoskeletal System
  Back pain 8.4 4.5 1.5 0.9 0.7
Nervous System/ Psychiatric
  Headache 5.4 9.6 6.0 2.4 2.8
  Dizziness 3.0 3.9 0.9 0.5 0.7
  Somnolence 2.4 3.3 3.3 0 0
Skin and Skin Appendage
  Pruritus 4.2 2.4 1.8 0.5 0
  Rash 1.2 0.6 2.4 1.1 0.5
Respiratory System
  Cough 1.5 0.3 0.6 1.6 1.0
  Difficulty breathing/ dyspnea/ shortness of breath 0 0.6 0.3 1.8 1.0
Urogenital System
  Nephrolithiasis/ urolithiasis 8.7 7.8 2.1 2.6 0.3
  Dysuria 1.5 2.4 0.3 0.4 0.2
Special Senses
  Taste perversion 2.7 8.4 1.2 0.2 0
*Including renal colic, and flank pain with and without hematuria

In Phase I and II controlled trials, the following adverse events were reported significantly more frequently by those randomized to the arms containing CRIXIVAN than by those randomized to nucleoside analogues: rash, upper respiratory infection, dry skin, pharyngitis, taste perversion.

Selected laboratory abnormalities of severe or life-threatening intensity reported in patients treated with CRIXIVAN alone, CRIXIVAN in combination with zidovudine or zidovudine plus lamivudine, zidovudine alone, or zidovudine plus lamivudine are presented in Table 11.

Table 11: Selected Laboratory Abnormalities of Severe or Life-threatening Intensity Reported in Studies 028 and ACTG 320

  Study 028 Considered Drug-Related and of Moderate or Severe Intensity Study ACTG 320 of Unknown Drug Relationship and of Severe or Life-threatening Intensity
CRIXIVAN Percent
(n=329)
CRIXIVAN plus Zidovudine Percent
(n=320)
Zidovudine Percent
(n=330)
CRIXIVAN plus Zidovudine plus Lamivudine Percent
(n=571)
Zidovudine plus Lamivudine Percent
(n=575)
Hematology
Decreased hemoglobin < 7.0 g/dL 0.6 0.9 3.3 2.4 3.5
Decreased platelet count < 50 THS/mm³ 0.9 0.9 1.8 0.2 0.9
Decreased neutrophils < 0.75 THS/mm³ 2.4 2.2 6.7 5.1 14.6
Blood chemistry
Increased ALT > 500% ULN* 4.9 4.1 3.0 2.6 2.6
Increased AST > 500% ULN 3.7 2.8 2.7 3.3 2.8
Total serum bilirubin > 250% ULN 11.9 9.7 0.6 6.1 1.4
Increased serum amylase > 200% ULN 2.1 1.9 1.8 0.9 0.3
Increased glucose > 250 mg/dL 0.9 0.9 0.6 1.6 1.9
Increased creatinine > 300% ULN 0 0 0.6 0.2 0
*Upper limit of the normal range.

Post-Marketing Experience

Body As A Whole: redistribution/accumulation of body fat (see PRECAUTIONS, Fat Redistribution).

Cardiovascular System: cardiovascular disorders including myocardial infarction and angina pectoris; cerebrovascular disorder.

Digestive System: liver function abnormalities; hepatitis including reports of hepatic failure (see WARNINGS); pancreatitis; jaundice; abdominal distention; dyspepsia.

Hematologic: increased spontaneous bleeding in patients with hemophilia (see PRECAUTIONS); acute hemolytic anemia (see WARNINGS).

Endocrine/Metabolic: new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, hyperglycemia (see WARNINGS).

Hypersensitivity: anaphylactoid reactions; urticaria; vasculitis.

Musculoskeletal System: arthralgia, periarthritis.

Nervous System/Psychiatric: oral paresthesia; depression.

Skin and Skin Appendage: rash including erythema multiforme and Stevens-Johnson syndrome; hyperpigmentation; alopecia; ingrown toenails and/or paronychia; pruritus.

Urogenital System: nephrolithiasis/urolithiasis, in some cases resulting in renal insufficiency or acute renal failure, pyelonephritis with or without bacteremia (see WARNINGS); interstitial nephritis sometimes with indinavir crystal deposits; in some patients, the interstitial nephritis did not resolve following discontinuation of CRIXIVAN; renal insufficiency; renal failure; leukocyturia (see PRECAUTIONS), crystalluria; dysuria.

Laboratory Abnormalities

Increased serum triglycerides; increased serum cholesterol.

Read the entire FDA prescribing information for Crixivan (Indinavir Sulfate) »

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Crixivan - User Reviews

Crixivan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Crixivan sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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