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CAS Number: 31677-93-7
The common adverse effects associated with 12-hour sustained-release
bupropion (with the greatest difference from placebo) are dry mouth, nausea,
insomnia, tremor, excessive sweating and tinnitus. Those that most often
resulted in interruption of the treatment in the same trial were rash (2.4%)
and nausea (0.8%). The development of mild to moderate skin rashes is
associated with sensitivity to dye components within the pill coating. This
can often be alleviated simply by prescribing a differently colored
pillSeizure is the most controversial side effect of bupropion, and was
responsible for its initial withdrawal from the market. The risk of seizure
is highly dose-dependent: 0.1% at 100–300 mg of bupropion, 0.4% at 300–450
mg, and 2% at 600 mg. For comparison, the incidence of the first unprovoked
seizure in the general population is 0.07–0.09%. The risk of seizure for
other antidepressants is as follows: 0.1–0.6% for imipramine, depending on
dosage; 0–0.06% for amitriptyline, depending on dosage; 0.5% for
clomipramine; 0.4% for maprotiline; and 0.2% for fluoxetine and fluvoxamine.
Experiments on mice indicate that increased susceptibility to seizure is a
general side effect of chronically using antidepressants that inhibit
norepinephrine transporter, such as imipramine, desipramine and reboxetine.
Clinical depression itself was reported to increase the occurrence of
seizures two-to-sevenfold compared with the general population; in this
light, the above statistics could indicate that low to moderate doses of
antidepressants, including bupropion, may actually have an anti-convulsive
Body (General): Frequent were asthenia, fever, and headache. Infrequent were
back pain, chills, inguinal hernia, musculoskeletal chest pain, pain, and
photosensitivity. Rare was malaise. Also observed were arthralgia, myalgia,
and fever with rash and other symptoms suggestive of delayed
hypersensitivity. These symptoms may resemble serum sicknessCardiovascular:
Infrequent were flushing, migraine, postural hypotension, stroke,
tachycardia, and vasodilation. Rare was syncope. Also observed were
cardiovascular disorder, complete AV block, extrasystoles, hypotension,
hypertensionDigestive: Frequent were dyspepsia, flatulence, and vomiting.
Infrequent were abnormal liver function, bruxism, dysphagia, gastric reflux,
gingivitis, glossitis, jaundice, and stomatitis. Rare was edema of tongue.
Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum
hemorrhage, hepatitis, increased salivation, intestinal perforation, liver
damage, pancreatitis, stomach ulcer, and stool abnormality.Endocrine: Also
observed were hyperglycemia, hypoglycemia, and syndrome of inappropriate
antidiuretic hormone.Hemic and Lymphatic: Infrequent was ecchymosis. Also
observed were anemia, leukocytosis, leukopenia, lymphadenopathy,
pancytopenia, and thrombocytopenia. Altered PT and/or INR, infrequently
associated with hemorrhagic or thrombotic complications, were observed when
bupropion was co-administered with warfarin.
Metabolic and Nutritional: Infrequent were edema, increased weight, and
peripheral edema. Also observed was glycosuria.
Musculoskeletal: Infrequent were leg cramps and twitching. Also observed
were arthritis and muscle rigidity/fever/rhabdomyolysis, and muscle
Nervous System: Frequent were agitation, depression, and irritability.
Infrequent were abnormal coordination, CNS stimulation, confusion, decreased
libido, decreased memory, depersonalization, emotional lability, hostility,
hyperkinesia, hypertonia, hypesthesia, paresthesia, suicidal ideation, and
vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Also
observed were abnormal electroencephalogram (EEG), aggression, akinesia,
aphasia, coma, delirium, delusions, dysarthria, dyskinesia, dystonia,
euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased
libido, manic reaction, neuralgia, neuropathy, paranoid ideation,
restlessness, and unmasking tardive dyskinesia.
Respiratory: Rare was bronchospasm. Also observed was pneumonia.
Skin: Frequent was sweating. Infrequent was acne and dry skin. Rare was
maculopapular rash. Also observed were alopecia, angioedema, exfoliative
dermatitis, and hirsutism.
Special Senses: Frequent was blurred vision or diplopia. Infrequent were
accommodation abnormality and dry eye. Also observed were deafness,
increased intraocular pressure, and mydriasis.
Urogenital: Frequent was urinary frequency. Infrequent were impotence,
polyuria, and urinary urgency. Also observed were abnormal ejaculation,
cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection,
prostate disorder, salpingitis, urinary incontinence, urinary retention,
urinary tract disorder, and vaginitis.