March 26, 2017
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Forfivo XL

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Forfivo XL




Forfivo XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/5/2016

Forfivo XL (bupropion hydrochloride) Extended-release is an antidepressant of the aminoketone class indicated for the treatment of major depressive disorder. Forfivo XL is available as a generic termed bupropion. Common side effects of Forfivo XL include dry mouth, nausea, insomnia, dizziness, sore throat, abdominal pain, agitation, anxiety, tremor, heart palpitations, sweating, ringing in the ears, muscle pain, weight loss, urinary frequency, and rash. Tell your doctor if you experience anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), or suicidal thoughts or behaviors while taking Forfivo XL.

Forfivo XL is supplied as 450 mg strength tablets that should be taken once daily without food. The tablet should be swallowed whole and should not be crushed, divided, or chewed. Patients are advised that Forfivo XL should be discontinued and not restarted if they experience a seizure while on treatment. Although Forfivo XL is not indicated for smoking cessation treatment, it contains the same active ingredient as Zyban which is approved for this use. Forfivo XL may interact with orphenadrine, thiotepa, cyclophosphamide, ticlopidine, clopidogrel, prasugrel, ritonavir, lopinavir, efavirenz, cimetidine, carbamazepine, phenobarbital, phenytoin, antidepressants, beta-blockers, antiarrhythmics, antipsychotics, and nicotine transdermal system (NTS). Tell your doctor all medications and supplements you use. Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy. It is not known if Forfivo XL can harm unborn babies. Patients should notify their doctors if they are breastfeeding or plan to breastfeed. It is not known if Forfivo XL passes through breast milk. Forfivo's safety and effectiveness has not been demonstrated in the pediatric population.

Our Forfivo XL Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Forfivo XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Commonly Observed Adverse Reactions In Controlled Clinical Trials Of Sustained-Release Bupropion Hydrochloride

Adverse reactions that occurred in at least 5% of patients treated with bupropion hydrochloride sustained-release (300 and 400 mg/day) and at a rate at least twice the placebo rate are listed below.

300 mg/Day Of Bupropion Hydrochloride Sustained-Release

anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/Day Of Bupropion Hydrochloride Sustained-Release

abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

FORFIVO XL is bioequivalent to three 150-mg tablets of WELLBUTRIN XL®, which has been demonstrated to have similar bioavailability both to the immediate-release and the sustained-release formulations of bupropion. The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride.

Major Depressive Disorder

Adverse Reactions Leading to Discontinuation of Treatment with Bupropion Hydrochloride Immediate-release, Bupropion Hydrochloride Sustained-release, and Bupropion Hydrochloride Extended-release Formulations in Major Depressive Disorder Trials

In placebo-controlled clinical trials with bupropion hydrochloride sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day, and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300-mg/day or 400-mg/day groups and at a rate at least twice the placebo rate are listed in Table 2.

Table 2. Treatment Discontinuation Due to Adverse Reactions in Placebo-controlled Trials in Major Depressive Disorder

Adverse Reaction Term Placebo
(N = 385)
Bupropion Hydrochloride Sustained-release 300 mg/day
(N = 376)
Bupropion Hydrochloride Sustained-release 400 mg/day
(N = 114)
Rash 0.0% 2.4% 0.9%
Nausea 0.3% 0.8% 1.8%
Agitation 0.3% 0.3% 1.8%
Migraine 0.3% 0.0% 1.8%

In clinical trials with bupropion hydrochloride immediate-release, 10% of patients and volunteers discontinued due to an adverse reaction. Reactions resulting in discontinuation (in addition to those listed above for the sustained-release formulation) included vomiting, seizures, and sleep disturbances.

Adverse Reactions Occurring at an Incidence of > 1% in Patients Treated With Bupropion Hydrochloride Immediate-release or Bupropion Hydrochloride Sustained-release Formulations in Major Depressive Disorder Trials

Table 3 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion hydrochloride sustained-release at 300 mg/day and 400 mg/day. These include reactions that occurred in either the 300-mg/day or 400-mg/day group at an incidence of 1% or more and were more frequent than in the placebo group.

Table 3. Adverse Reactions in Placebo-controlled Trials for Major Depressive Disorder

Body System/ Adverse Reaction Placebo
(N = 385)
Bupropion Hydrochloride Sustained-release 300 mg/day
(N = 376)
Bupropion Hydrochloride Sustained-release 400 mg/day
(N = 114)
Body (General)
  Headache 23% 26% 25%
  Infection 6% 8% 9%
  Abdominal pain 2% 3% 9%
  Asthenia 2% 2% 4%
  Chest pain 1% 3% 4%
  Pain 2% 2% 3%
  Fever - 1% 2%
Cardiovascular
  Palpitation 2% 2% 6%
  Flushing - 1% 4%
  Migraine 1% 1% 4%
  Hot flashes 1% 1% 3%
Digestive
  Dry mouth 7% 17% 24%
  Nausea 8% 13% 18%
  Constipation 7% 10% 5%
  Diarrhea 6% 5% 7%
  Anorexia 2% 5% 3%
  Vomiting 2% 4% 2%
  Dysphagia 0% 0% 2%
Musculoskeletal
  Myalgia 3% 2% 6%
  Arthralgia 1% 1% 4%
  Arthritis 0% 0% 2%
  Twitch - 1% 2%
Nervous System
  Insomnia 6% 11% 16%
  Dizziness 5% 7% 11%
  Agitation 2% 3% 9%
  Anxiety 3% 5% 6%
  Tremor 1% 6% 3%
  Nervousness 3% 5% 3%
  Somnolence 2% 2% 3%
  Irritability 2% 3% 2%
  Memory decreased 1% - 3%
  Paresthesia 1% 1% 2%
  Central nervous system stimulation 1% 2% 1%
Respiratory
  Pharyngitis 2% 3% 11%
  Sinusitis 2% 3% 1%
  Increased cough 1% 1% 2%
Skin
  Sweating 2% 6% 5%
  Rash 1% 5% 4%
  Pruritus 2% 2% 4%
  Urticaria 0% 2% 1%
Special Senses
  Tinnitus 2% 6% 6%
  Taste perversion - 2% 4%
  Blurred vision or diplopia 2% 3% 2%
Urogenital
  Urinary frequency 2% 2% 5%
  Urinary urgency 0% - 2%
  Vaginal hemorrhagea - 0% 2%
  Urinary tract infection - 1% 0%
a = Incidence based on the number of female patients.
— = Denotes adverse reactions occurring in greater than 0 but less than 0.5% of patients.

The following additional adverse reactions occurred in controlled trials of bupropion hydrochloride immediate-release (300 to 600 mg/day) at an incidence of at least 1% more frequently than in the placebo group: cardiac arrhythmia (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), menstrual complaints (5% vs 1%), akathisia (2% vs 1%), impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%), decreased libido (3% vs 2%), hostility (6% vs 4%), auditory disturbance (5% vs 3%), and gustatory disturbance (3% vs 1%).

Changes in Body Weight

Table 4 presents the incidence of body weight changes (≥ 5 lbs) in the short-term MDD trials using bupropion hydrochloride sustained-release. There was a dose-related decrease in body weight.

Table 4. Incidence of Weight Gain or Weight Loss (≥ 5 lbs) in Placebo-controlled Trials of Bupropion Hydrochloride Sustained-release Tablets for Major Depressive Disorder

Weight Change Placebo
(N = 347)
Bupropion Hydrochloride Sustained-release 300 mg/day
(N = 339)
Bupropion Hydrochloride Sustained-release 400 mg/day
(N = 112)
Gained > 5 lbs 4% 3% 2%
Lost > 5 lbs 6% 14% 19%

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of bupropion hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body (General)—chills, facial edema, edema, peripheral edema, musculoskeletal chest pain, photosensitivity, and malaise.

Cardiovascular—postural hypotension, hypertension, stroke, vasodilation, syncope, complete atrioventricular block, extrasystoles, myocardial infarction, phlebitis, and pulmonary embolism.

Digestive—abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, thirst, edema of tongue, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.

Endocrine—hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone secretion.

Hemic and Lymphatic—ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.

Metabolic and Nutritional—glycosuria.

Musculoskeletal—leg cramps, fever/rhabdomyolysis, and muscle weakness.

Nervous System—abnormal coordination, depersonalization, emotional lability, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, derealization, abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

Respiratory—bronchospasm and pneumonia.

Skin—maculopapular rash, alopecia, angioedema, exfoliative dermatitis, and hirsutism.

Special Senses—accommodation abnormality, dry eye, deafness, increased intraocular pressure, angle-closure glaucoma, and mydriasis.

Urogenital—impotence, polyuria, prostate disorder, abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

Read the entire FDA prescribing information for Forfivo XL (Bupropion Hydrochloride)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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