"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.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 Consumer (continued)
Nausea, vomiting, dry mouth, headache, constipation, increased sweating, joint aches, sore throat, blurred vision, strange taste in the mouth, diarrhea, or dizziness 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 using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, fainting, fast/pounding/irregular heartbeat, hearing problems, ringing in the ears, severe headache, mental/mood changes (e.g., agitation, anxiety, confusion, hallucinations, memory loss), uncontrolled movements (tremor), unusual weight loss or gain.
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.
Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).
This drug may infrequently cause seizures. Seek immediate medical attention if you experience a seizure. If you have a seizure while taking bupropion, you should not take this drug again.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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 Wellbutrin (bupropion hcl) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also the 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures or conditions that increase your risk of seizures (including brain/head injury, brain tumors, arteriovenous malformation, eating disorders such as bulimia/anorexia nervosa), alcohol/drug dependence (including benzodiazepines, narcotic pain medicines, cocaine and stimulants), diabetes, heart disease (e.g., congestive heart failure, high blood pressure, recent heart attack), kidney problems, liver problems (e.g., cirrhosis), personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, intent to quit smoking, personal or family history of glaucoma (angle-closure type).
This medication should not be used if you are suddenly stopping regular use of sedatives (including benzodiazepines such as lorazepam), drugs used to treat seizures, or alcohol. Doing so may increase your risk of seizures.
Though uncommon, depression can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, worsening depression, or any other mental/mood changes (including new or worsening anxiety, agitation, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, rapid speech, unusual behavior changes). Keep all medical appointments so your doctor can monitor your progress closely and adjust or change your medication if needed.
This drug may make you dizzy or affect your coordination. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol can also increase your risk of dizziness or seizures.
Older adults may be more sensitive to the side effects of this drug, especially dizziness and memory loss. Dizziness can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Since untreated mental/mood problems (such as depression, seasonal affective disorder, bipolar disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Additional Wellbutrin 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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