Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Crixivan. If you are concerned about side effects, discuss the risks and benefits of Crixivan with your doctor.

The following side effects have been reported by at least 1% of people taking Crixivan. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• increased fat on the upper back, neck, breasts, and around the trunk; and loss of fat from the legs, arms, and face
• muscle aches or pain
• numbness of the mouth
• shoulder pain or stiffness
• signs of Anemia (e.g.,pale skin, shortness of breath, fatigue)
• signs of increased blood sugar or Diabetes, e.g.:
• cuts that don't heal
• fruity mouth odour
• increased thirst
• increased urination
• signs of infection (e.g., Fever or chills, sore throat, cough)
• signs of kidney stones (e.g., painful urination, blood in urine, sharp back pain just below the ribs)
• signs of liver problems, e.g.:
• dark urine
• diarrhea
• loss of appetite
• nausea
• pale stools
• vomiting
• weight loss
• yellowing of the skin or whites of the eyes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Heart Attack, e.g.:
• chest pain or pressure
• nausea and vomiting
• pain extending through shoulder and arm
• sweating
• signs of a serious allergic reaction, e.g.:
• abdominal cramps
• difficulty breathing
• nausea and vomiting
• swelling of the face and throat
• signs of a severe skin reaction, e.g.:
• a rash combined with fever or discomfort
• a rash covering a large area of the body
• a rash that spreads quickly
• blistering
• peeling
• signs of pancreatitis, e.g.:
• abdominal pain on the upper left side
• back pain
• chills
• fever
• nausea
• rapid heartbeat
• swollen abdomen

Each white, semi-translucent capsule, coded "CRIXIVAN™ 400 mg" in green, contains indinavir 400 mg (as a sulfate salt ethanolate). Nonmedicinal ingredients: anhydrous lactose 149.6 mg (as a diluent) and magnesium stearate (as a lubricant); empty capsule shell: gelatin and titanium dioxide.

Do not take Crixivan if you:

• are allergic to indinavir or any ingredients of the medication
• are taking any of the following medications:
• Alfuzosin
• Alprazolam
• Amiodarone
• atazanivir
• cisapride
• ergot derivatives (e.g., ergotamine, Dihydroergotamine)
• midazolam
• Pimozide
• rifampin
• St. John's wort
• "statin" cholesterol lowering medications (e.g., Lovastatin, Simvastatin)
• Sildenafil (when used to treat pulmonary arterial hypertension)
• Triazolam
• have galactose intolerance or glucose malabsorption (a rare hereditary disease)
• have reduced liver function caused by cirrhosis

There may be an interaction between indinavir and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Crixivan. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Crixivan.

Bleeding problems: Indinavir may put people with Hemophilia at a higher risk of bleeding while taking this medication. If you have hemophilia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Crixivan, and whether any special monitoring is needed.

Indinavir may also reduce the number of platelets in the blood. Platelets are responsible for forming clots. If you experience unusual bruising or bleeding, bleeding gums, unusual nosebleeds, stools that look like coffee grounds, or blood in your urine, contact your doctor immediately.

Diabetes: Indinavir may cause diabetes or increase blood sugar levels. If you have diabetes, discuss with your doctor how Crixivan may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.

If you experience symptoms of diabetes, such as frequent urination or increased thirst, or a fruity odour to your breath, contact your doctor.

Fat redistribution: Over time, Crixivan may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, on the breast, and around the back, chest, and stomach area; or loss of fat from the legs, arms, and face. The long-term effects of this are not known.

Immune reconstitution syndrome: Crixivan may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or Tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: Indinavir can cause kidney stones. To reduce the possibility of developing this painful side effect, it is advised that you drink 1.5 L of water each day. If you experience signs of kidney stones, such as sharp pain in the side or abdomen, blood in the urine or painful urination, contact your doctor as soon as possible.

If you have reduced kidney function or Kidney Disease, discuss with your doctor how Crixivan may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Indinavir is removed from the body by the liver and may cause liver problems. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Crixivan, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Red blood cells: Indinavir may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Stopping the medication: If you stop taking Crixivan, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: The safety and effectiveness of using indinavir during pregnancy are not known. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Crixivan, contact your doctor immediately.

Breast-feeding: It is not known if indinavir passes into breast milk. Women with HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection, since the virus can be transmitted through breast milk.

Children: Studies have shown that children are more likely to develop kidney stones than adults if they take indinavir. Indinavir is not recommended for children.

Seniors: The safety and effectiveness of indinavir have not been established for seniors.