"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complaine"...
Wellbutrin SR Consumer (continued)
Dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, muscle/joint aches, dizziness, or blurred vision may occur. If any of these effects persist or worsen, notify 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 do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, chest pain, fast heartbeat, severe headache, uncontrolled movements (tremor), unusual weight loss or gain, ringing in the ears, mental/mood changes (e.g., agitation, anxiety, hallucinations, nervousness, confusion, restlessness).
Tell your doctor immediately if any of these rare but very serious side effects occur: muscle pain/tenderness/weakness, change in the amount of urine.
This drug may rarely cause seizures. Seek immediate medical attention if you have a seizure while taking bupropion. If you have a seizure while taking bupropion, you should not take this drug again.
A severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a severe allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
An empty tablet shell may appear in your stool. This is harmless.
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 Wellbutrin SR (bupropion hydrochloride sustained-release) Side Effects Center for a complete guide to possible side effects »
PRECAUTIONS: See also How to Use and Warning Sections
Before taking bupropion, 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: seizures, eating disorders (e.g., bulimia, anorexia nervosa).
This medication should not be used if you are suddenly stopping regular use of sedatives (e.g., benzodiazepines such as lorazepam) or alcohol, which can cause a higher risk of seizures.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, head injury, brain tumor, liver problems, heart problems, high blood pressure, kidney problems, diabetes, alcohol/drug dependence, intention to quit smoking.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
Limit or avoid consumption of alcoholic beverages. Alcohol can increase your risk of dizziness and seizures.
Do not take this medicine with any other product containing bupropion (e.g., drugs to help quit smoking) since large doses of bupropion are more likely to cause seizures.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug and to side effects.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infrequently, newborns whose mothers have used certain newer antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Promptly report any such symptoms to the doctor. However, do not stop taking this medication unless your doctor directs you to do so.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Additional Wellbutrin SR 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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