Applies to bupropion / dextromethorphan: oral tablet extended release.

Serious side effects

Along with its needed effects, bupropion / dextromethorphan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bupropion / dextromethorphan:

Less common

• Fear, nervousness

Incidence not known

• Absence of or decrease in body movement
• attack, assault, force
• bigger, dilated, or enlarged pupils (black part of the eye)
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• bloody, black, tarry stools
• bloody or cloudy urine
• bluish color
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in vision
• changes in patterns and rhythms of speech
• changes in skin color
• chest pain or tightness
• chills
• cold sweats
• coma
• confusion
• confusion as to time, place, or person
• cool, pale skin
• cough
• cracks in the skin
• dark urine
• deafness
• decrease in frequency of urination
• decreased urine output
• depression
• diarrhea
• difficult, burning, or painful urination
• difficulty in passing urine (dribbling)
• difficulty in swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• extra heartbeats
• eye pain
• fainting
• false or unusual sense of well-being
• feeling, seeing, or hearing things that are not there
• feeling that others can hear your thoughts
• feeling that others are watching you or controlling your behavior
• fever
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• hallucinations
• headache
• heartburn
• holding false beliefs that cannot be changed by fact
• inability to move the eyes
• increased blinking or spasms of the eyelid
• increased hunger
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased sensitivity of the eyes to light
• increased thirst
• increased urination
• indigestion
• irritability
• itching
• itching of the vagina or genital area
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lip smacking or puckering
• loss of appetite
• loss of bladder control
• loss of heat from the body
• loss of vision
• muscle cramps, spasms, pain, stiffness, tightness, or weakness
• nausea
• nerve pain
• nightmares
• pain during sexual intercourse
• pain or burning in the throat
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pounding, slow heartbeat
• pounding in the ears
• problems with speech or speaking
• puffing of cheeks
• rapid or worm-like movements of tongue
• red, swollen, or scaly skin
• red irritated eyes
• red skin lesions, often with a purple center
• restlessness
• seizures
• sensation of pins and needles
• severe mood or mental changes
• shakiness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stabbing pain
• sticking out of the tongue
• stomach cramps, tenderness, pain, or burning
• sugar in the urine
• sweating
• swelling of the breasts or breast soreness in both females and males
• swelling of the face, ankles, or hands
• swelling of the foot or leg
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• swollen glands
• tenderness
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thick, white vaginal discharge with no odor or with a mild odor
• thoughts of killing oneself changes in behavior
• trouble breathing
• trouble sleeping
• trouble speaking
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled chewing movements
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unexplained weight loss
• unusual behavior
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual facial expressions
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting
• vomiting of blood or material that looks like coffee grounds
• watery or bloody diarrhea
• yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking bupropion / dextromethorphan:

Symptoms of overdose

• Agitation
• blurred vision
• coma
• confusion
• dark-colored urine
• decreased awareness or responsiveness
• diarrhea
• difficult or trouble breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fever
• hyperexcitability
• inability to move the eyes
• increased blinking or spasms of the eyelid
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• mental depression or anxiety
• muscle cramps, spasms, pain, stiffness, or tightness
• nausea
• nightmares or unusually vivid dreams
• overactive reflexes
• pale or blue lips, fingernails, or skin
• poor coordination
• seeing, hearing, or feeling things that are not there
• seizures
• severe sleepiness
• shakiness and unsteady walk
• shivering
• sticking out of the tongue
• sweating
• talking or acting with excitement you cannot control
• trembling or shaking
• twitching
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual facial expressions
• unusual tiredness or weakness
• vomiting

Other side effects

Some side effects of bupropion / dextromethorphan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Increased sweating

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• constipation

Incidence not known

• Feeling of discomfort
• inflammation of the joints
• loss or thinning of the hair
• muscle aches

For Healthcare Professionals

Applies to bupropion / dextromethorphan: oral tablet extended release.

General

The most common adverse reactions reported were dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis. In 1 study, 4% of patients treated with this drug discontinued therapy due to adverse reactions; the adverse reaction that led to discontinuation most often was anxiety.^[Ref]

Cardiovascular

Bupropion:

-Frequency not reported: Elevated blood pressure, hypertension

-Postmarketing reports: Complete atrioventricular block, extrasystoles, hypotension, hypertension (some severe cases), phlebitis^[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis

Bupropion:

-Postmarketing reports: Rash, alopecia, angioedema, exfoliative dermatitis, hirsutism, Stevens-Johnson syndrome^[Ref]

Endocrine

Bupropion:

-Postmarketing reports: Syndrome of inappropriate antidiuretic hormone secretion, gynecomastia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13%)

Common (1% to 10%): Diarrhea, dry mouth, constipation

Bupropion:

-Postmarketing reports: Colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, intestinal perforation, pancreatitis, stomach ulcer

Dextromethorphan:

-Postmarketing reports: Nausea, vomiting, stomach pain^[Ref]

Genitourinary

Bupropion:

-Postmarketing reports: Glycosuria, abnormal ejaculation, cystitis, dyspareunia, dysuria, painful erection, salpingitis, urinary incontinence, urinary retention, vaginitis^[Ref]

Hematologic

Altered prothrombin time and/or INR (infrequently associated with hemorrhagic/thrombotic complications) were observed when bupropion was coadministered with warfarin.^[Ref]

Bupropion:

-Postmarketing reports: Anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, altered prothrombin time, altered INR, hemorrhagic/thrombotic complications^[Ref]

Hepatic

Bupropion:

-Postmarketing reports: Hepatitis^[Ref]

Hypersensitivity

Bupropion:

-Postmarketing reports: Delayed hypersensitivity, serum sickness-like symptoms^[Ref]

Arthralgia, myalgia, fever with rash, and other symptoms suggestive of delayed hypersensitivity have been reported during postmarketing experience with bupropion; such symptoms have resembled serum sickness.^[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Bupropion:

-Postmarketing reports: Hyperglycemia, hypoglycemia, hyponatremia^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia

Bupropion:

-Postmarketing reports: Arthralgia, myalgia, muscle rigidity/fever/rhabdomyolysis, muscle weakness^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 16%)

Common (1% to 10%): Headache, somnolence, paresthesia (includes paresthesia, hypoesthesia)

Bupropion:

-Uncommon (0.1% to 1%): Seizure

-Postmarketing reports: Abnormal electroencephalogram, akinesia, aphasia, coma, dysarthria, extrapyramidal syndrome (dyskinesia, dystonia, hypokinesia, parkinsonism), neuralgia, neuropathy, unmasking tardive dyskinesia

Dextromethorphan:

-Postmarketing reports: Drowsiness, dizziness^[Ref]

Ocular

Common (1% to 10%): Vision blurred

Bupropion:

-Frequency not reported: Pupillary dilation, angle closure glaucoma

-Postmarketing reports: Increased intraocular pressure, mydriasis^[Ref]

Other

Common (1% to 10%): Fatigue (includes fatigue, lethargy)

Bupropion:

-Postmarketing reports: Fever, deafness, menopause^[Ref]

Psychiatric

Common (1% to 10%): Sexual dysfunction (includes orgasm abnormal, erectile dysfunction, libido decreased, anorgasmia), anxiety, insomnia

Bupropion:

-Frequency not reported: Neuropsychiatric signs/symptoms (including delusions, hallucinations, psychosis, concentration disturbance, paranoia, confusion)

-Postmarketing reports: Aggression, agitation, completed suicide, delirium, delusions, depression, euphoria, hallucinations, homicidal ideation, hostility, increased libido, manic reaction, panic, paranoid ideation, psychosis, restlessness, suicide ideation, suicide attempt

Dextromethorphan:

-Postmarketing reports: Nervousness/restlessness

Antidepressant drugs:

-Frequency not reported: Suicidal thoughts, suicidal behaviors, manic/mixed/hypomanic episode precipitated^[Ref]

Respiratory

Bupropion:

-Postmarketing reports: Pulmonary embolism, pneumonia^[Ref]