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Aplenzin

Last reviewed on RxList: 5/22/2017
Aplenzin Side Effects Center

Last reviewed on RxList 05/23/2017

Aplenzin (bupropion hydrobromide) is an antidepressant used to treat major depressive disorder (MDD) and seasonal affective disorder. The Zyban brand of bupropion is used to help people stop smoking by reducing cravings and other withdrawal effects. Common side effects of Aplenzin include:

  • dry mouth,
  • sore throat,
  • nausea,
  • vomiting,
  • stomach or abdominal pain,
  • flushing,
  • headache,
  • loss of appetite,
  • constipation,
  • trouble sleeping,
  • increased sweating,
  • strange taste in mouth,
  • joint aches,
  • dizziness,
  • blurred vision,
  • ringing in your ears,
  • loss of interest in sex,
  • sore throat,
  • muscle pain,
  • itching or skin rash,
  • increased urination, or
  • weight loss or gain.

Antidepressants such as Aplenzin may increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. Tell your doctor if this occurs. Tell your doctor if you have serious side effects of Aplenzin including:

  • fast/pounding/irregular heartbeat,
  • mental/mood changes (such as anxiety, agitation, confusion, unusual behavior or thinking, memory loss),
  • seizures,
  • eye pain/swelling/redness, or
  • vision changes (such as seeing rainbows around lights at night).

The recommended starting dose of Aplenzin for MDD is 174 mg once daily in the morning. After 4 days, the dose may be increased to the target dose of 348 mg once daily in the morning. Aplenzin may interact with medication used to prevent blood clots, cancer medicines, heart or blood pressure medications, HIV/AIDS medications, other antidepressants, medicines to treat psychiatric disorders, antihistamines, asthma medications or bronchodilators, birth control pills or estrogens, bladder or urinary medications, antibiotics, diet pills, stimulants, ADHD medications, insulin or oral diabetes medications, medications for nausea, vomiting, or motion sickness; anti-malarials; Parkinson's medications, restless leg syndrome, or pituitary gland tumor (prolactinoma); organ transplant medicines, narcotics, sedatives, steroids, street drugs, theophylline, or ulcer or irritable bowel medications. Tell your doctor all medications and supplements you use. Aplenzin should be used only when prescribed during pregnancy. Infrequently, newborns whose mothers have used certain antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Tell your doctor if you notice these symptoms in your newborn. Do not stop taking this medication unless your doctor directs you to do so. Aplenzin passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Aplenzin (bupropion hydrobromide) 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.

Aplenzin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • seizure (convulsions);
  • fast heartbeats;
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • confusion, trouble concentrating, hallucinations, unusual thoughts or behavior; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • dry mouth, nausea, stomach pain;
  • headache, dizziness, ringing in your ears;
  • loss of interest in sex;
  • sore throat, muscle pain;
  • mild itching or skin rash, increased sweating, increased urination; or
  • changes in appetite, weight loss or gain.

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.

Read the entire detailed patient monograph for Aplenzin (Bupropion Hydrobromide Tablet)

Aplenzin Professional Information

SIDE EFFECTS

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

  • Suicidal thoughts and behaviors in children, adolescents, and young adults [see WARNINGS AND PRECAUTIONS]
  • Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see WARNINGS AND PRECAUTIONS]
  • Seizure [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Activation of mania or hypomania [see WARNINGS AND PRECAUTIONS]
  • Psychosis and other neuropsychiatric events [see WARNINGS AND PRECAUTIONS]
  • Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

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 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 HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.

300 mg/day of bupropion HCl sustained-release (equivalent to APLENZIN 348 mg/day): anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of bupropion HCl sustained-release (equivalent to APLENZIN 464 mg/day): abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

APLENZIN is bioequivalent to bupropion HCl extended-release, 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 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 HCl Immediate-Release, Bupropion HCl Sustained-Release, and Bupropion HCl Extended-Release in Major Depressive Disorder Trials

In placebo-controlled clinical trials with bupropion HCl 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 3.

Table 3: Treatment Discontinuation Due to Adverse Reactions in Placebo-Controlled Trials in MDD

Adverse Reaction Term Placebo
(n=385)
Bupropion HCl Sustained-Release 300 mg/day*
(n=376)
Bupropion HCl 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%
* Equivalent to 348 mg/day bupropion HBr
** Equivalent to 464 mg/day bupropion HBr

In clinical trials with bupropion HCl 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 HCl Immediate-Release or Bupropion HCl Sustained-Release in MDD

Table 4 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion HCl sustained-release 300 mg/day and 400 mg/day. These include reactions that occurred in either the 300 mg or 400 mg group at an incidence of 1% or more and were more frequent than in the placebo group.

Table 4: Adverse Reactions in Placebo-Controlled Trials in Patients with MDD

Body System/Adverse Reaction Placebo
(n=385)
Bupropion HCl Sustained-Release 300 mg/day*
(n=376)
Bupropion HCl 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 hemorrhage - 0% 2%
  Urinary tract infection - 1% 0%
* Equivalent to 348 mg/day bupropion HBr
** Equivalent to 464 mg/day bupropion HBr
Incidence based on the number of female patients.
— Hyphen 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 HCl immediate-release (300 to 600 mg per day) at an incidence of at least 1% more frequently than in the placebo group were: cardiac arrhythmia (5% vs. 4%), hypertension (4% vs. 2%), hypotension (3% vs. 2%), tachycardia (11% vs. 9%), appetite increased (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%).

Seasonal Affective Disorder

In placebo-controlled clinical trials in SAD, 9% of patients treated with bupropion HCl extended-release and 5% of patients treated with placebo discontinued treatment because of adverse reactions. The adverse reactions leading to discontinuation in at least 1% of patients treated with bupropion and at a rate numerically greater than the placebo rate were insomnia (2% vs. <1%) and headache (1% vs. <1%).

Table 5 summarizes the adverse reactions that occurred in patients treated with bupropion HCl extended-release for up to approximately 6 months in 3 placebo-controlled trials. These include reactions that occurred at an incidence of 2% or more and were more frequent than in the placebo group.

Table 5: Adverse Reactions in Placebo-Controlled Trial in Patients with SAD

System Organ Class/Preferred Term Placebo
(n=511)
Bupropion HCl Extended-Release
(n=537)
Gastrointestinal Disorder
  Dry mouth 15% 26%
  Nausea 8% 13%
  Constipation 2% 9%
  Flatulence 3% 6%
  Abdominal pain <1% 2%
Nervous System Disorders
  Headache 26% 34%
  Dizziness 5% 6%
  Tremor <1% 3%
Infections and Infestations
  Nasopharyngitis 12% 13%
  Upper respiratory tract infection 8% 9%
  Sinusitis 4% 5%
Psychiatric Disorders
  Insomnia 13% 20%
  Anxiety 5% 7%
  Abnormal dreams 2% 3%
  Agitation <1% 2%
Musculoskeletal and Connective Tissue Disorders
  Myalgia 2% 3%
  Pain in extremity 2% 3%
Respiratory, Thoracic, and Mediastinal Disorders
  Cough 3% 4%
General Disorders and Administration Site Conditions
  Feeling jittery 2% 3%
Skin and Subcutaneous Tissue Disorders
  Rash 2% 3%
Metabolism and Nutrition Disorders
  Decreased appetite 1% 4%
Reproductive System and Breast Disorders
  Dysmenorrhea <1% 2%
Ear and Labyrinth Disorders
  Tinnitus <1% 3%
Vascular Disorders
  Hypertension 0% 2%

Changes in Body Weight

Table 6 presents the incidence of body weight changes (≥5 lbs) in the short-term MDD trials using bupropion HCl sustained-release. There was a dose-related decrease in body weight.

Table 6: Incidence of Weight Gain or Weight Loss (≥5 lbs) in MDD Trials Using Bupropion HCl Sustained-Release

Weight Change Bupropion HCl Sustained-Release 300 mg/day*
(n=339)
Bupropion HCl Sustained-Release 400 mg/day**
(n=112)
Placebo
(n=347)
Gained >5 lbs 3% 2% 4%
Lost >5 lbs 14% 19% 6%
* Equivalent to 348 mg/day bupropion HBr
** Equivalent to 464 mg/day bupropion HBr

Table 7 presents the incidence of body weight changes (≥5 lbs) in the 3 SAD trials using bupropion HCl extended-release. A higher proportion of subjects in the bupropion group (23%) had a weight loss ≥5 lbs, compared to the placebo group (11%). These were relatively long-term trials (up to 6 months).

Table 7: Incidence of Weight Gain or Weight Loss (≥5 lbs) in SAD Trials Using Bupropion HCl

Weight Change Bupropion HCl Extended-Release 150 to 300 mg/day
(n=537)
Placebo
(n=511)
Gained >5 lbs 11% 21%
Lost >5 lbs 23% 11%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of APLENZIN. 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, 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 Aplenzin (Bupropion Hydrobromide Tablet)

Related Resources for Aplenzin

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Read the Aplenzin User Reviews »

© Aplenzin Patient Information is supplied by Cerner Multum, Inc. and Aplenzin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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