Aplenzin Side Effects

Generic Name: bupropion,bupropion hydrochloride

Please note - some side effects for Aplenzin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Aplenzin - for the Consumer

Aplenzin Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aplenzin Extended-Release Tablets:

Constipation; dizziness; drowsiness; dry mouth; flushing; gas; headache; increased sweating; increased urination; loss of appetite; muscle pain; nausea; nervousness; restlessness; ringing in the ears; stomach pain; taste changes; trouble sleeping; vomiting; weakness; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur when using Aplenzin Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; painful sores in the mouth or around the eyes; tightness in the chest; swollen lymph nodes; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; delusions; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; hearing problems; menstrual changes; new or worsening mental or mood changes (eg, concentration problems, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being or inability to sit still); pale stools; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent joint or muscle pain; severe or persistent nausea, vomiting, or stomach pain; severe or persistent nervousness, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor; unusual swelling; vision changes; worsening depression; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Aplenzin Side Effects - for the Professional

Aplenzin

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

• Clinical worsening and suicide risk [see WARNINGS AND PRECAUTIONS Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders (5.1)]
• Activation of Psychosis and/or Mania [see WARNINGS AND PRECAUTIONS: Activation of Psychosis and/or Mania (5.3) and WARNINGS AND PRECAUTIONS: Screening Patients for Bipolar Disorder (5.4)]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS: Potential for Hepatotoxicity(5.7)]
• Agitation and Insomnia [see WARNINGS AND PRECAUTIONS: Agitation and Insomnia (5.8)]
• Psychosis, confusion and other neuropsychiatric phenomena [see WARNINGS AND PRECAUTIONS: Psychosis, Confusion, and Other Neuropsychiatric Phenomena (5.9)]
• Altered appetite [see WARNINGS AND PRECAUTIONS: Altered Appetite and Weight (5.10)]
• Allergic reactions, including anaphylactoid/anaphylactic reactions, erythema multiforme, Stevens-Johnson syndrome and other symptoms suggestive of delayed hypersensitivity [see WARNINGS AND PRECAUTIONS: Allergic Reactions (5.11)]
• Hypertension [see WARNINGS AND PRECAUTIONS: Cardiovascular Effects (5.12)]

Commonly Observed Adverse Reactions in Controlled Clinical Trials

Adverse reactions from Table 5 occurring in at least 5% of patients treated with the sustained-release formulation of bupropion hydrochloride and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg/day dose groups.

300 mg/day of WELLBUTRIN SR (equivalent to 348 mg/day bupropion HBr): Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of WELLBUTRIN SR (equivalent to 464 mg/day bupropion HBr): Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

Aplenzin is bioequivalent to WELLBUTRIN XL, which has been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion. The information included under this subsection and under the subsections 6.2 and 6.3 is based primarily on data from controlled clinical trials with WELLBUTRIN SR Tablets, the sustained-release formulation of bupropion hydrochloride.

Adverse Reactions Leading to Discontinuation of Treatment With WELLBUTRIN or WELLBUTRIN SR

In placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day, respectively, of the sustained-release formulation of bupropion hydrochloride and 4% of patients treated with placebo discontinued treatment due to adverse reactions. The specific adverse reactions in these trials that led to discontinuation in at least 1% of patients treated with either 300 mg/day or 400 mg/day of WELLBUTRIN SR, the sustained-release formulation of bupropion hydrochloride, and at a rate at least twice the placebo rate are listed in Table 4.

Table 4. Treatment Discontinuations Due to Adverse Reactions in Placebo-Controlled Trials for Major Depressive Disorder

Adverse Reaction Term	WELLBUTRIN® SR (Bupropion HCl) 300 mg/day * (n = 376)	WELLBUTRIN® SR (Bupropion HCl) 400 mg/day† (n = 114)	Placebo (n = 385)
* Equivalent to 348 mg/day bupropion HBr † Equivalent to 464 mg/day bupropion HBr
Rash	2.4%	0.9%	0.0%
Nausea	0.8%	1.8%	0.3%
Agitation	0.3%	1.8%	0.3%
Migraine	0.0%	1.8%	0.3%

In clinical trials with the immediate-release formulation of bupropion, 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 of bupropion hydrochloride, include vomiting, seizures, and sleep disturbances.

Adverse Reactions Occurring at an Incidence of 1% or More Among Patients Treated With WELLBUTRIN or WELLBUTRIN SR

Table 5 enumerates treatment-emergent adverse reactions that occurred among patients treated with 300 and 400 mg/day of the sustained-release formulation of bupropion hydrochloride and with placebo in controlled trials. Reactions that occurred in either the 300- or 400-mg/day group at an incidence of 1% or more and were more frequent than in the placebo group are included. Reported adverse reactions were classified using a COSTART-based Dictionary.

Accurate estimates of the incidence of adverse reactions associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward reactions in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions.

Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the reactions. A better perspective on the serious adverse reactions associated with the use of bupropion is provided in WARNINGS AND PRECAUTIONS section (5).

Table 5. Treatment-Emergent Adverse Reactions in Placebo-Controlled Trials* for Major Depressive Disorder

Body System/Adverse Reaction	WELLBUTRIN® SR (Bupropion HCl) 300 mg/day† (n = 376)	WELLBUTRIN® SR (Bupropion HCl) 400 mg/day‡ (n = 114)	Placebo (n = 385)
— Hyphen denotes adverse reactions occurring in greater than 0 but less than 0.5% of patients.
* Adverse reactions that occurred in at least 1% of patients treated with either 300 or 400 mg/day of the sustained-release formulation of bupropion hydrochloride, but equally or more frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome, hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder. † Equivalent to 348 mg/day bupropion HBr ‡ Equivalent to 464 mg/day bupropion HBr § Incidence based on the number of female patients.
Body (General)
Headache	26%	25%	23%
Infection	8%	9%	6%
Abdominal pain	3%	9%	2%
Asthenia	2%	4%	2%
Chest pain	3%	4%	1%
Pain	2%	3%	2%
Fever	1%	2%	—
Cardiovascular
Palpitation	2%	6%	2%
Flushing	1%	4%	—
Migraine	1%	4%	1%
Hot flashes	1%	3%	1%
Digestive
Dry mouth	17%	24%	7%
Nausea	13%	18%	8%
Constipation	10%	5%	7%
Diarrhea	5%	7%	6%
Anorexia	5%	3%	2%
Vomiting	4%	2%	2%
Dysphagia	0%	2%	0%
Musculoskeletal
Myalgia	2%	6%	3%
Arthralgia	1%	4%	1%
Arthritis	0%	2%	0%
Twitch	1%	2%	—
Nervous system
Insomnia	11%	16%	6%
Dizziness	7%	11%	5%
Agitation	3%	9%	2%
Anxiety	5%	6%	3%
Tremor	6%	3%	1%
Nervousness	5%	3%	3%
Somnolence	2%	3%	2%
Irritability	3%	2%	2%
Memory decreased	—	3%	1%
Paresthesia	1%	2%	1%
Central nervous system stimulation	2%	1%	1%
Respiratory
Pharyngitis	3%	11%	2%
Sinusitis	3%	1%	2%
Increased cough	1%	2%	1%
Skin
Sweating	6%	5%	2%
Rash	5%	4%	1%
Pruritus	2%	4%	2%
Urticaria	2%	1%	0%
Special senses
Tinnitus	6%	6%	2%
Taste perversion	2%	4%	—
Blurred vision or diplopia	3%	2%	2%
Urogenital
Urinary frequency	2%	5%	2%
Urinary urgency	—	2%	0%
Vaginal hemorrhage§	0%	2%	—
Urinary tract infection	1%	0%	—

Additional reactions to those listed in Table 5 that occurred at an incidence of at least 1% in controlled clinical trials of the immediate-release formulation of bupropion hydrochloride (300 to 600 mg/day) and that were numerically more frequent than placebo were: cardiac arrhythmias (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase (4% vs 2%), dyspepsia (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%).

Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion

In addition to the adverse events noted above, the following events have been reported in clinical trials and postmarketing experience with the sustained-release formulation of bupropion hydrochloride in depressed patients and in nondepressed smokers, as well as in clinical trials and postmarketing clinical experience with the immediate-release formulation of bupropion hydrochloride.

Adverse events for which frequencies are provided below occurred in clinical trials with the sustained-release formulation of bupropion hydrochloride. The frequencies represent the proportion of patients who experienced a treatment-emergent adverse event on at least one occasion in placebo-controlled studies for depression (n = 987) or smoking cessation (n = 1,013), or patients who experienced an adverse event requiring discontinuation of treatment in an open-label surveillance study with the sustained-release formulation of bupropion hydrochloride (n = 3,100). All treatment-emergent adverse events are included except those listed in Tables 2 through 5, those events listed in other safety-related sections, those adverse events subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events not reasonably associated with the use of the drug, and those events that were not serious and occurred in fewer than 2 patients. Events of major clinical importance are described in WARNINGS AND PRECAUTIONS section (5).

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, while rare events are those occurring in less than 1/1,000 patients.

Adverse events for which frequencies are not provided occurred in clinical trials or postmarketing experience with bupropion. Only those adverse events not previously listed for sustained-release bupropion are included. The extent to which these events may be associated with Aplenzin is unknown.

Body (General)

Infrequent were chills, facial edema, musculoskeletal chest 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 sickness [see WARNINGS AND PRECAUTIONS: Allergic Reactions (5.11)].

Cardiovascular

Infrequent were postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope. Also observed were complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe); [see WARNINGS AND PRECAUTIONS: Cardiovascular Effects (5.12)], myocardial infarction, phlebitis, and pulmonary embolism.

Digestive

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

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 coadministered with warfarin.

Metabolic and Nutritional

Infrequent were edema and peripheral edema. Also observed was glycosuria.

Musculoskeletal

Infrequent were leg cramps. Also observed were muscle rigidity/fever/rhabdomyolysis and muscle weakness.

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, completed suicide, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

Respiratory

Rare was bronchospasm. Also observed was pneumonia.

Skin

Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative dermatitis, and hirsutism.

Special Senses

Infrequent were accommodation abnormality and dry eye. Also observed were deafness, diplopia, increased intraocular pressure, and mydriasis.

Urogenital

Infrequent were impotence, polyuria, and prostate disorder. Also observed were abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have frequently included headache (27%), insomnia (16% to 33%), dizziness (12%), tremor, somnolence, thinking abnormality, abnormal dreams (6%), sleep abnormalities, disturbed concentration, dysphoria, decreased memory, paresthesia, central nervous system (CNS) stimulation, akathisia, migraine, impaired sleep quality, pseudoparkinsonism, sedation, sensory disturbance, seizure, myoclonus, and dysarthria. Abnormal coordination, confusion, decreased libido, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, abnormal electroencephalogram (EEG), akinesia, aphasia, coma, dyskinesia, dystonia, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, unmasking tardive dyskinesia, abnormal neurological exam, impaired attention, sciatica, and aphasia have been reported rarely.

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 seizure risk associated with bupropion is dose-related but may also be dependent on concomitant predisposing factors, such as: a history of seizure disorder or head trauma; concomitant treatment with agents that lower seizure threshold (antipsychotics, antidepressants, theophylline, systemic steroids, etc.); or circumstances associated with increased risk of seizures (abrupt withdrawal of a benzodiazepine or alcohol, excessive alcohol intake, addiction to opiates, etc). One retrospective analysis has suggested that advancing age may be protective against bupropion- induced seizures.

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.

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

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

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Gastrointestinal

Gastrointestinal side effects have frequently included dry mouth (12% to 28%), nausea (9% to 15%), constipation (7%), diarrhea (9%), bloating (7%), cramps (7%), anorexia, vomiting, dysphagia, increase in appetite, taste perversion, abdominal pain, and dyspepsia. Bruxism, gastric reflux, gingivitis, glossitis, increased salivation, mouth ulcers, stomatitis, thirst disturbance, increased salivary flow, and flatulence have been reported infrequently. Edema of the tongue, gustatory disturbance, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, intestinal perforation, pancreatitis, stomach ulcer, and stool abnormality have been reported rarely.

Genitourinary

One study in which 150 patients received the sustained released form of bupropion 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).

Genitourinary side effects have included urinary frequency, urinary urgency, vaginal hemorrhage, urinary tract infection, impotence, menstrual complaints/irregularities, nocturia, and polyuria. Abnormal ejaculation, dyspareunia, dysuria, gynecomastia, menopause, painful erection, prostate disorder, salpingitis, urinary incontinence, urinary retention, urinary tract disorder, vaginitis, cystitis, vaginal irritation, testicular swelling, enuresis, glycosuria, ovarian disorder, pelvic infection, and painful ejaculation have been reported rarely.

Psychiatric

Psychiatric side effects have frequently included anxiety (6%), nervousness, agitation, depression, irritability, derealization, and hypomania. Depersonalization, emotional lability, hostility, suicidal ideation, aggression, delusions, euphoria, hallucinations, manic reaction, nightmares, paranoid ideation, delirium, psychosis, organic mental disorders, catatonia, restlessness, and completed suicide have been reported rarely.

The Australian Adverse Drug Reaction Advisory Committee reported that 285 of the 780 reports it received in association with bupropion 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).

Cardiovascular

Cardiovascular side effects have frequently included palpitation, cardiac arrhythmias, hypertension (in some cases severe), hypotension, syncope, tachycardia, and edema. Postural hypotension, chest pain, electrocardiogram (ECG) abnormalities (premature beats and nonspecific ST- T changes), stroke, and vasodilation have been reported infrequently. Phlebitis and myocardial infarction have been reported rarely. There are also reports of complete atrioventricular (AV) block, extrasystoles, bradycardia, and myocardial infarction. Some investigators have suggested that bupropion therapy may be 10 to 100 times less likely to induce conduction problems than tricyclic antidepressants.

Hypertension has been reported regarding both patients with and without evidence of preexisting hypertension.

Dermatologic

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

Dermatologic side effects have frequently included sweating, hives (6%), rash (6%), pruritus (6%), urticaria, flushing, pallor, and dry skin. Alopecia and acne have been reported infrequently. Angioedema, exfoliative dermatitis, maculopapular rash, change in hair color, and hirsutism have been reported rarely. Two cases of erythema multiforme have also been reported.

Endocrine

Endocrine side effects have infrequently included syndrome of inappropriate antidiuretic hormone and hormone level changes.

Hematologic

Hematologic side effects have rarely included ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, and eosinophilia.

Hypersensitivity

Hypersensitivity side effects have rarely included reports of anaphylactoid reactions during clinical trials. In addition, there have been isolated cases of anaphylactic shock associated with bupropion.

Other

Other side effects have frequently included flu-like symptoms (3%), asthenia, pain, fatigue, fever/chills, and auditory disturbance. Facial edema, photosensitivity, peripheral edema, deafness, body odor, tinnitus, and malaise have been reported rarely.

False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion. This can happen even following discontinuation of therapy. This is due to lack of specificity of some screening tests. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish bupropion from amphetamines.

Metabolic

Metabolic side effects have frequently included weight loss and weight gain. Hyponatremia, hyperglycemia, hypoglycemia have also been reported in patients receiving bupropion.

Musculoskeletal

Musculoskeletal side effects have frequently included arthritis. Leg cramps, musculoskeletal chest pain, muscle rigidity, rhabdomyolysis, and muscle weakness have been reported rarely.

Hepatic

Hepatic side effects have rarely included jaundice, abnormal liver function tests, hepatic damage, and hepatitis.

Respiratory

Respiratory side effects have frequently included upper respiratory complaints and cough. Bronchospasm, bronchitis, dyspnea, epistaxis, rate or rhythm disorder, pulmonary embolism, and pneumonia have been reported rarely.

Ocular

Ocular side effects have rarely included accommodation abnormality, dry eye, diplopia, mydriasis, blurred vision, and increased intraocular pressure.

Immunologic

Immunologic side effects have included isolated cases of Stevens-Johnson syndrome and serum sickness-like reactions.

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