"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Daraprim Consumer (continued)
Nausea, vomiting, and loss of appetite 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 using this medication may develop serious side effects including blood problems, especially at higher doses. This risk can be reduced with the use of folic/folinic acid and regular blood tests. Tell your doctor immediately if any of these symptoms occur: easy bruising/bleeding, signs of serious infection (such as high fever, severe chills, persistent sore throat), signs of low red blood cell count (such as severe tiredness, pale lips/nails/skin, fast heartbeat/breathing with usual activities), swollen/painful tongue.
Seek immediate medical attention if any of these rare but very serious side effects occur: bloody/pink urine, chest pain, slow/fast/irregular heartbeat.
A very serious allergic reaction to this drug is rare. However, stop this medication immediately and 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 Daraprim (pyrimethamine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking pyrimethamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, kidney problems, liver problems, a certain type of low red blood cell count (megaloblastic anemia due to low blood folate), low folic acid levels from other conditions (such as malnutrition, problems with absorption of food, alcoholism), low red/white blood cell counts, low blood-clotting cell (platelet) count.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Folic acid is very important during pregnancy. Your doctor will prescribe folic/folinic acid to prevent low folate levels.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Additional Daraprim Information
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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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