Wellbutrin XL NDA 21-515

583 and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble

584 serum sickness (see PRECAUTIONS).

585 Cardiovascular: Infrequent were postural hypotension, stroke, tachycardia, and

586 vasodilation. Rare was syncope. Also observed were complete atrioventricular block,

587 extrasystoles, hypertension (in some cases severe, see PRECAUTIONS),

588 myocardial infarction, phlebitis, and pulmonary embolism.

589 Digestive: Infrequent were abnormal liver function, bruxism, gastric reflux, gingivitis,

590 glossitis, increased salivation, jaundice, moth ulcers, stomatitis, and thirst. Rare was edema of

591 tongue. Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage,

592 hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.

593 Endocrine: Also observed were hyperglycemia, hypoglycemia, and syndrome of

594 inappropriate antidiuretic hormone.

595 Hemic and Lymphatic: Infrequent was ecchymosis. Also observed were anemia,

596 leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and throbocytopenia. Altered PT

597 and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were

598 observed when bupropion was coadministered with warfarin.

599 Metabolic and Nutritional: Infrequent were edema and peripheral edema. Also observed

600 was glycosuria.

601 Musculoskeletal: Infrequent were leg cramps. Also observed were muscle

602 rigidity/fever/rhabdomyolysis and muscle weakness.

603 Nervous System: Infrequent were abnormal coordination, decreased libido,

604 depersonalization, dysphoria, emotional lability, hostility, hyperkinesias, hypertonia, hypesthesia,

605 suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Also

606 observed were abnormal electroencephalogram (EEG), akinesia, aphasia, coma, delirium,

607 dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations,

608 hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid reaction, and

609 unmasking tardive dyskinesia.

610 Respiratory: Rare was bronchospasm. Also observed was pneumonia.

611 Skin: Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative

612 dermatitis, and hirsutism.

613 Special Senses: Infrequent were accommodation abnormality and dry eye. Also observed

614 were deafness, diplopia, and mydriasis.

615 Urogenital: Infrequent were impotence, polyuria, and prostate disorder. Also observed were

616 abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection,

617 salpingitis, urinary incontinence, urinary retention, and vaginitis.

618 DRUG ABUSE AND DEPENDENCE

619 Controlled Substance Class: Bupropion is not a controlled substance.