"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
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- Patient Information:
Details with Side Effects
Human Overdose Experience
Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one-third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.
Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.
Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physician's Desk Reference (PDR). Call 1-800-222-1222 or refer to www.poison.org.
There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Induction of emesis is not recommended.
- WELLBUTRIN SR is contraindicated in patients with a seizure disorder.
- WELLBUTRIN SR is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see WARNINGS AND PRECAUTIONS].
- WELLBUTRIN SR is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
- The use of MAOIs (intended to treat psychiatric disorders) concomitantly with WELLBUTRIN SR or within 14 days of discontinuing treatment with WELLBUTRIN SR is contraindicated. There is an increased risk of hypertensive reactions when WELLBUTRIN SR is used concomitantly with MAOIs. The use of WELLBUTRIN SR within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting WELLBUTRIN SR in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and DRUG INTERACTIONS].
- WELLBUTRIN SR is contraindicated in patients with known hypersensitivity to bupropion or other ingredients of WELLBUTRIN SR. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 1/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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