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Forfivo XL Side Effects

Generic Name: bupropion

Note: This page contains information about the side effects of bupropion. Some of the dosage forms included on this document may not apply to the brand name Forfivo XL.

In Summary

Common side effects of Forfivo XL include: dizziness, insomnia, nausea, pharyngitis, weight loss, and xerostomia. Other side effects include: abdominal pain, agitation, anxiety, arthralgia, chest pain, migraine, myalgia, palpitations, skin rash, tinnitus, tremor, urinary frequency, hypertension, anorexia, diaphoresis, dysgeusia, and flushing. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to bupropion: oral tablet, oral tablet extended release, oral tablet extended release 12 hr, oral tablet extended release 24 hr

In addition to its needed effects, some unwanted effects may be caused by bupropion (the active ingredient contained in Forfivo XL). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking bupropion:

More common:
  • Anxiety
  • dry mouth
  • hyperventilation
  • irregular heartbeats
  • irritability
  • restlessness
  • shaking
  • shortness of breath
  • trouble sleeping
Less common:
  • Buzzing or ringing in the ears
  • headache (severe)
  • skin rash, hives, or itching
  • Confusion
  • fainting
  • false beliefs that cannot be changed by facts
  • having extreme distrust of people
  • seeing, hearing, or feeling things that are not there
  • seizures (convulsions)
  • trouble concentrating
Incidence not known:
  • Actions that are out of control
  • anger
  • assaulting others
  • attacking others
  • being aggressive
  • being impulsive
  • chest pain or discomfort
  • fast or pounding heartbeat
  • force
  • inability to sit still
  • need to keep moving
  • sweating
  • talking, feeling, or acting with excitement

Minor Side Effects

Some of the side effects that can occur with bupropion may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Abdominal or stomach pain
  • constipation
  • decrease in appetite
  • dizziness
  • increased sweating
  • trembling
  • weight loss (unusual)
Less common:
  • Blurred vision
  • change in sense of taste
  • drowsiness
  • frequent need to urinate
  • sore throat
  • unusual feeling of wellbeing

For Healthcare Professionals

Applies to bupropion: oral tablet, oral tablet extended release


In placebo-controlled clinical studies, the specific adverse events that led to discontinuation in at least 1% of patients treated with either 300 mg or 400 mg per day of Wellbutrin SR (R)included rash, nausea, agitation, and migraine. Additional events leading to discontinuation in the immediate-release formulation included mental state abnormalities, vomiting, seizures, headaches, and sleep disturbances, many of which occurred at doses greater than the recommended daily dose.

Adverse events leading to treatment discontinuation with Zyban (R) included tremors, and rashes. The most commonly observed adverse reactions were dry mouth and insomnia. Smoking cessation is often associated with nicotine withdrawal symptoms, some of which are also recognized as adverse events associated with bupropion (the active ingredient contained in Forfivo XL) [Ref]


The Australian Adverse Drug Reaction Advisory Committee reported that 285 of the 780 reports it received in association with bupropion (the active ingredient contained in Forfivo XL) through mid-May 2001 involved psychological disturbances.

Two cases of tactile hallucinations ("bugs crawling over skin") have been reported in association with bupropion extended-release (200 mg twice daily) therapy. In both cases the symptoms abated following a reduction in the total daily dose of bupropion (300 mg daily).

Insomnia may also be dose-dependent. In a dose response clinical study for smoking cessation, 29% of patients receiving bupropion 150 mg/day versus 35% of those receiving 300 mg/day reported insomnia. Insomnia may be minimized by reducing the dosage or avoiding administration at bedtime.[Ref]

Very common (10% or more): Insomnia
Common (1% to 10%): Abnormal dreams, agitation, anxiety, confusion, decreased memory, delusions, depression, disturbed concentration, euphoria, hallucinations, hostility, impaired sleep quality, irritability, mania/hypomania, nervousness, thinking abnormality
Uncommon (0.1% to 1%): Bruxism, depersonalization, dysphoria, emotional lability, formal thought disorder, frigidity, mood instability, paranoia, psychosis, suicidal ideation
Rare (less than 0.1%): Derealization, dysarthria, impaired attention, suicidal ideation
Very rare (0.01% to 0.1%): Aggression, paranoid ideation, restlessness
Frequency not reported: Completed suicide, delirium, manic reaction, suicide attempt[Ref]

Nervous system

The Australian Adverse Drug Reaction Advisory Committee reported that 268 of the 780 reports it received in association with bupropion (the active ingredient contained in Forfivo XL) through mid-May 2001 involved nervous system disorders.

Grand mal seizures have been reported in 0.4% of patients undergoing bupropion therapy at dosages up to 450 mg daily. The incidence of seizures increases dramatically at higher dosages. The seizure rate in patients taking sustained-release bupropion up to a dosage of 300 mg/day (e.g. for smoking cessation) has been approximated at 0.1%.

The risk of seizure appears to be dose-related. Other risk factors are related to patient factors e.g., severe head injury, arteriovenous malformation, CNS tumor or CNS infection, or severe stroke, concomitant medications that lower the seizure threshold (e.g., other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic corticosteroids), metabolic disorders, illicit drug use, abuse or misuse of prescription drugs such as CNS stimulants, diabetes mellitus treated with oral hypoglycemics or insulin, treatment with anorectic drugs, and excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates.

Two cases of elderly patients falling backwards have been attributed to the effects of bupropion on the basal ganglia.[Ref]

Very common (10% or more): Dizziness, headache, sedation
Common (1% to 10%): Akathisia, central nervous system stimulation, decreased memory, dyskinesia, dystonia, myoclonus, paresthesia, somnolence, taste perversion, tremor
Uncommon (0.1% to 1%): Abnormal coordination, hypesthesia, hyperkinesia, hypertonia
Rare (less than 0.1%): Abnormal electroencephalogram, amnesia, ataxia, migraine, parkinsonism, seizure, syncope
Frequency not reported: Akinesia, aphasia, coma, extrapyramidal syndrome, hypokinesia, neuralgia, neuropathy, unmasking tardive dyskinesia
Postmarketing reports: Dysarthria[Ref]


Very Common (10% or more): Tachycardia
Common (1% to 10%): Cardiac arrhythmias, chest pain, flushing, hot flashes, hypertension, hypotension, migraine, palpitation
Uncommon (0.1% to 1%): Edema, electrocardiogram abnormalities (premature beats and nonspecific ST-T changes), peripheral edema, postural hypotension, stroke, vasodilation
Rare (less than 0.1%): Myocardial infarction
Frequency not reported: Cardiovascular disorder, complete AV block, extrasystoles, phlebitis
Postmarketing reports: Third degree heart block[Ref]

In clinical practice, hypertension, in some cases severe, requiring acute treatment, has been reported in patients receiving bupropion alone and in combination with nicotine replacement therapy. These events have been observed in both patients with and without evidence of preexisting hypertension.

Some investigators have suggested that bupropion therapy may be 10 to 100 times less likely to induce conduction problems than tricyclic antidepressants.[Ref]


Very common (10% or more): Constipation, dry mouth, nausea, vomiting
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, dysphagia, flatulence, gustatory disturbance, stomatitis
Uncommon (0.1% to 1%): Gastric reflux, gingivitis, glossitis, gum irritation, increased salivation, inguinal hernia, mouth ulcer, oral edema, thirst disturbance, toothache
Rare (less than 0.1%): Edema of the tongue, intestinal perforation
Frequency not reported: Colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, pancreatitis, stomach ulcer, stool abnormality[Ref]


One study in which 150 patients received the sustained released form of bupropion (the active ingredient contained in Forfivo XL) reported the incidence of orgasm dysfunction at 8% in patients receiving a 300 mg daily dose and 10% in patients receiving a 400 mg daily dose.

Among antidepressants, bupropion may be associated with the lowest incidence of sexual dysfunction (i.e., impotence, abnormal ejaculation, changes in libido).[Ref]

Common (1% to 10%): Decrease in sexual function, dysmenorrhea, increased/decreased libido, menstrual complaints, nocturia, urinary frequency, urinary tract infection, urinary urgency, vaginal hemorrhage
Uncommon (0.1% to 1%): Impotence, polyuria, prostate disorder, testicular swelling, vaginal irritation
Rare (less than 0.1%): Enuresis, urinary incontinence
Frequency not reported: Abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary retention, vaginitis
Postmarketing reports: Prostate disorder, urinary tract disorder[Ref]


The Australian Adverse Drug Reaction Advisory Committee reported that 307 of the 780 reports it received in association with bupropion (the active ingredient contained in Forfivo XL) through mid- May 2001 involved skin reactions. Urticaria was the most commonly reported event (167 cases). Other rashes (86 cases) were also reported.[Ref]

Common (1% to 10%): Dry skin, pruritus, rash, sweating, urticaria
Uncommon (0.1% to 1%): Alopecia, ecchymosis
Rare (less than 0.1%): Erythema multiforme, exacerbation of psoriasis, maculopapular rash, photosensitivity, Stevens-Johnson syndrome
Frequency not reported: Angioedema, exfoliative dermatitis, hirsutism[Ref]


Frequency not reported: Syndrome of inappropriate antidiuretic hormone[Ref]


Frequency not reported: Anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia[Ref]


Uncommon (0.1% to 1%): Abnormal liver function, jaundice
Rare (less than 0.1%): Hepatitis, liver damage[Ref]


Common (1% to 10%): Allergic reaction
Uncommon (0.1% to 1%): Fever with rash and other symptoms suggestive of delayed hypersensitivity
Frequency not reported: Serum sickness-like reaction[Ref]


Common (1% to 10%): Anorexia, decreased appetite, increased appetite
Rare (less than 0.1%): Blood glucose disturbances, glycosuria[Ref]


Common (1% to 10%): Arthralgia, arthritis, musculoskeletal chest pain, myalgia, neck pain, pain in extremity, twitch
Uncommon (0.1% to 1%): Leg cramps
Frequency not reported: Muscle rigidity, muscle weakness, rhabdomyolysis[Ref]


Common (1% to 10%): Blurred vision or diplopia
Uncommon (0.1% to 1%): Accommodation abnormality, dry eye, mydriasis, visual disturbance
Frequency not reported: Increased intraocular pressure[Ref]


Common (1% to 10%): Accidental injury, asthenia, auditory disturbance, feeling jittery, fever, infection, pain, sensory disturbance, temperature disturbance, tinnitus
Uncommon (0.1% to 1%): Chills, facial edema, vertigo
Rare (less than 0.1%): Malaise
Frequency not reported: Deafness[Ref]


Very common (10% or more): Nasopharyngitis, pharyngitis, rhinitis
Common (1% to 10%): Bronchitis, dyspnea, epistaxis, increased cough, sinusitis, upper respiratory tract infection
Rare (less than 0.1%): Bronchospasm
Frequency not reported: Pneumonia, pulmonary embolism[Ref]


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Not all side effects for Forfivo XL may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.