FDA Adverse Events Reports (FAERS) Summary for BUSPAR

These tables and charts are based on 11,694 total reports for BUSPAR (BUSPIRONE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 10,901 pharmaceutical company-submitted and non-U.S. FAERS reports and 793 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 793 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch BUSPAR summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	ANXIETY	970
2	NAUSEA	944
3	DRUG INEFFECTIVE	871
4	FATIGUE	797
5	HEADACHE	718
6	DEPRESSION	712
7	DIZZINESS	679
8	PAIN	655
9	INSOMNIA	573
10	SHORTNESS OF BREATH	560
11	DIARRHEA	515
12	VOMITING	470
13	OFF LABEL USE	469
14	WEIGHT INCREASED	449
15	FALL	436
16	FEELING ABNORMAL	421
17	LACK OF STRENGTH AND ENERGY (ASTHENIA)	409
18	MALAISE	395
19	TREMOR	383
20	SUICIDAL IDEATION	375
21	WEIGHT DECREASED	372
22	JOINT PAIN	357
23	DROWSINESS	340
24	PAIN IN EXTREMITY	333
25	BACK PAIN	321
26	CHEST PAIN	304
27	HIGH BLOOD PRESSURE	288
28	CONFUSIONAL STATE	285
29	RASH	282
30	CONDITION AGGRAVATED	269
31	ABDOMINAL PAIN	264
32	GAIT DISTURBANCE	259
33	MUSCLE SPASMS	253
34	CONSTIPATION	252
35	DRUG HYPERSENSITIVITY	243
36	PNEUMONIA	240
37	DIABETES MELLITUS	237
38	EXCESS SWEATING	237
39	ITCHING	233
40	FEVER	233
41	ABDOMINAL PAIN UPPER	230
42	DECREASED APPETITE	225
43	PINS AND NEEDLES	220
44	PANIC ATTACK	216
45	URINARY TRACT INFECTION	216
46	AGITATION	212
47	COUGH	212
48	MEMORY IMPAIRMENT	209
49	TYPE 2 DIABETES MELLITUS	205
50	NUMBNESS	198
51	INJECTION SITE PAIN	197
52	MIGRAINE	192
53	VISION BLURRED	191
54	MUSCLE PAIN	188
55	PALPITATIONS	186
56	DRUG INTERACTION	181
57	BLOOD PRESSURE INCREASED	180
58	DEATH	180
59	DRUG WITHDRAWAL SYNDROME	167
60	GASTROOESOPHAGEAL REFLUX DISEASE	158
61	ABDOMINAL DISCOMFORT	157
62	DRUG DOSE OMISSION	157
63	HAIR LOSS	155
64	SWELLING OF LIMBS	154
65	DEHYDRATION	153
66	IRRITABILITY	152
67	KIDNEY FAILURE	152
68	HALLUCINATION	150
69	LOSS OF CONSCIOUSNESS	150
70	BLOOD GLUCOSE INCREASED	147
71	HEART RATE INCREASED	144
72	DISTURBANCE IN ATTENTION	143
73	PRODUCT DOSE OMISSION ISSUE	140
74	HEART ATTACK (MYOCARDIAL INFARCTION)	138
75	SEIZURE	137
76	BLOOD CHOLESTEROL INCREASED	136
77	LOW BLOOD PRESSURE	136
78	ANEMIA	134
79	CHEST DISCOMFORT	134
80	NERVOUSNESS	133
81	SUICIDE ATTEMPT	133
82	HYPERSENSITIVITY	131
83	OVERDOSE	131
84	CONVULSION	130
85	ANGER	129
86	STRESS	129
87	AMNESIA	124
88	INJURY	123
89	BRONCHITIS	120
90	SKIN REDNESS	120
91	BALANCE DISORDER	119
92	COVID-19	118
93	MUSCULAR WEAKNESS	118
94	CHRONIC KIDNEY DISEASE	117
95	ABDOMINAL DISTENSION	116
96	PULMONARY EMBOLISM	116
97	DRY MOUTH	114
98	CHILLS	113
99	INDIGESTION	113
100	SINUSITIS	112

Latest Known Outcomes for Reactions Reported for BUSPAR

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	4807
2	Patient has not recovered/symtoms have not resolved	2581
3	Patient recovered	2508
4	Patient is recovering/symptoms resolving	940
5	Patient died	272
6	Patient has recovered but has consequent health issues	58

Search all MedWatch and FAERS by keyword:

BUSPAR Total Reports

Male	Female	Unknown	Total
3160	7916	618	11,694

Top Countries Reporting

	Country	Number of Reports
1	United States	7806
2	France	23
3	Canada	21
4	South Korea	19
5	Puerto Rico	15
6	United Kingdom	14
7	Germany	9
8	Brazil	3
9	Denmark	3
10	Egypt	3

Outcomes for Reports

Serious: 6284
Not Serious: 5406
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

Top Companies Reporting

JOHNSON AND JOHNSON
ABBVIE
BIOGEN
ELI LILLY AND COMPANY
ALEXION PHARMACEUTICALS
JAZZ
TEVA
ROCHE
PFIZER
ACADIA PHARMACEUTICALS

Safety-Related FDA Updates

FDA Approval Date: 1996-04-22

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

Notes

This report, created by AskaPatient.com, is derived from the cases for BUSPAR 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 April 28, 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.