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Aplenzin (Bupropion Hydrobromide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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

  • •Clinical worsening and suicide risk [see Warnings and Precautions ]
  • •Neuropsychiatric symptoms 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 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 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 subsections 6.2 and 6.3 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 1
(n=376)
Bupropion HCl Sustained-Release 400 mg/day 2
(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%

1 Equivalent to 348 mg/day bupropion HBr
2 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 are included.

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 1
(n=376)
Bupropion HCl Sustained-Release 400 mg/day 2
(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 3

0%

2%

    Urinary tract infection

4

1%

0%

1 Equivalent to 348 mg/day bupropion HBr
2 Equivalent to 464 mg/day bupropion HBr
3 Incidence based on the number of female patients.
4 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 Trials 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 1
(n=339)
Bupropion HCl
Sustained-Release
400 mg/day 2
(n=112)
Placebo
(n=347)

Gained >5 lbs

3%

2%

4%

Lost >5 lbs

14%

19%

6%

1 Equivalent to 348 mg/day bupropion HBr
2 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 Extended-Release
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.



REPORTS OF SUSPECTED APLENZIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Aplenzin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Aplenzin side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: 55 year old female weighing 68.0 kg (149.7 pounds)

Reactions: Photosensitivity Reaction, Urticaria, Rash

Suspect drug(s):
Aplenzin



See index of all Aplenzin side effect reports >>

Drug label data at the top of this Page last updated: 2014-07-31

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