FDA Adverse Events Reports (FAERS) Summary for APLENZIN

These tables and charts are based on 291 total reports for APLENZIN (BUPROPION HYDROBROMIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 275 pharmaceutical company-submitted and non-U.S. FAERS reports and 16 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 16 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch APLENZIN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with APLENZIN (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	25
2	ANXIETY	21
3	HEADACHE	19
4	FATIGUE	18
5	CONVULSION	17
6	DEPRESSION	17
7	NAUSEA	13
8	FEELING ABNORMAL	12
9	PRODUCT RESIDUE PRESENT	12
10	RASH	12
11	PAIN	11
12	DIARRHEA	10
13	DIZZINESS	10
14	INSOMNIA	10
15	TREMOR	10
16	BLOOD PRESSURE INCREASED	9
17	JOINT PAIN	8
18	HOSPITALIZATION	8
19	INSURANCE ISSUE	8
20	PRODUCT SUBSTITUTION ISSUE	8
21	THERAPY INTERRUPTED	8
22	EXCESS SWEATING	7
23	SUICIDAL IDEATION	7
24	WEIGHT DECREASED	7
25	BACK PAIN	6
26	SHORTNESS OF BREATH	6
27	INCORRECT DOSE ADMINISTERED	6
28	LOSS OF CONSCIOUSNESS	6
29	MALAISE	6
30	MEMORY IMPAIRMENT	6
31	OFF LABEL USE	6
32	PRODUCT QUALITY ISSUE	6
33	RAPID HEART RATE (TACHYCARDIA)	6
34	ADVERSE DRUG REACTION	5
35	AGITATION	5
36	LACK OF STRENGTH AND ENERGY (ASTHENIA)	5
37	DYSKINESIA	5
38	FALL	5
39	IRRITABILITY	5
40	MUSCLE PAIN	5
41	PALPITATIONS	5
42	STRESS	5
43	VISION BLURRED	5
44	VOMITING	5
45	ABDOMINAL DISCOMFORT	4
46	ANGER	4
47	BALANCE DISORDER	4
48	CONSTIPATION	4
49	COUGH	4
50	DECREASED APPETITE	4
51	DISTURBANCE IN ATTENTION	4
52	DRUG DOSE OMISSION	4
53	DRY MOUTH	4
54	INDIGESTION	4
55	FEELING JITTERY	4
56	GAIT DISTURBANCE	4
57	HIGH BLOOD PRESSURE	4
58	MUSCLE TWITCHING	4
59	PAIN IN EXTREMITY	4
60	ITCHING	4
61	SINUSITIS	4
62	DROWSINESS	4
63	RINGING IN THE EARS	4
64	WEIGHT INCREASED	4
65	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	4
66	AGGRESSION	3
67	HAIR LOSS	3
68	CHRONIC KIDNEY DISEASE	3
69	CONDITION AGGRAVATED	3
70	CONFUSIONAL STATE	3
71	COVID-19	3
72	CRYING	3
73	DEATH	3
74	DEHYDRATION	3
75	DRUG HYPERSENSITIVITY	3
76	DRUG INTERACTION	3
77	DRUG INTOLERANCE	3
78	FLUSHING	3
79	NUMBNESS	3
80	INJECTION SITE REDNESS	3
81	INJECTION SITE ITCHING	3
82	INTENTIONAL PRODUCT USE ISSUE	3
83	LUNG NEOPLASM MALIGNANT	3
84	MUSCULAR WEAKNESS	3
85	HEART ATTACK (MYOCARDIAL INFARCTION)	3
86	COMMON COLD	3
87	NERVOUSNESS	3
88	NO ADVERSE EVENT	3
89	PRODUCT AVAILABILITY ISSUE	3
90	PRODUCT DOSE OMISSION ISSUE	3
91	KIDNEY FAILURE	3
92	SPEECH DISORDER	3
93	DRUG EFFECT INCOMPLETE	3
94	DRUG EFFECT INCREASED	3
95	URINARY TRACT INFECTION	3
96	HIVES	3
97	ABDOMINAL PAIN	2
98	ABDOMINAL PAIN UPPER	2
99	ABNORMAL DREAMS	2
100	ACUTE KIDNEY INJURY	2

Latest Known Outcomes for Reactions Reported for APLENZIN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	165
2	Patient has not recovered/symtoms have not resolved	53
3	Patient recovered	48
4	Patient is recovering/symptoms resolving	12
5	Patient died	6
6	Patient has recovered but has consequent health issues	1

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2009	10
2010	21
2011	9
2012	10
2013	6
2014	12
2015	15
2016	17
2017	11
2018	12
2019	17
2020	28
2021	29
2022	24
2023	32
2024	12
2025	18
2026	8

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	3
11-20	4
21-30	15
31-40	22
41-50	28
51-60	30
61-70	24
71-80	9
81-90	0
91+	1

Based on 136 reports that included a patient age.

APLENZIN Total Reports

Male	Female	Unknown	Total
69	207		291

Top Countries Reporting

	Country	Number of Reports
1	United States	240
2	Austria	1

Outcomes for Reports

Serious: 116
Not Serious: 175
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 2008-04-23

APLENZIN (BUPROPION HYDROBROMIDE) Rx Drug:
Risk of asceptic meningitis Safety-related Labeling Changes

Have experience (good or bad) with APLENZIN? Rate APLENZIN at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for APLENZIN reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.