FDA Adverse Events Reports (FAERS) Summary for ZONEGRAN

These tables and charts are based on 4,309 total reports for ZONEGRAN (ZONISAMIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 4,188 pharmaceutical company-submitted and non-U.S. FAERS reports and 121 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 121 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ZONEGRAN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	SEIZURE	475
2	CONVULSION	345
3	DRUG INEFFECTIVE	326
4	FATIGUE	240
5	DROWSINESS	212
6	HEADACHE	211
7	NAUSEA	205
8	DIZZINESS	188
9	FALL	155
10	OFF LABEL USE	151
11	DRUG INTERACTION	150
12	DEPRESSION	149
13	INSOMNIA	145
14	WEIGHT DECREASED	140
15	ANXIETY	139
16	VOMITING	137
17	DIARRHEA	131
18	RASH	129
19	PAIN	124
20	DECREASED APPETITE	117
21	CONDITION AGGRAVATED	111
22	WEIGHT INCREASED	105
23	EPILEPSY	103
24	AGGRESSION	102
25	LACK OF STRENGTH AND ENERGY (ASTHENIA)	101
26	SHORTNESS OF BREATH	96
27	FEELING ABNORMAL	93
28	TREMOR	93
29	MALAISE	88
30	FEVER	87
31	STATUS EPILEPTICUS	87
32	GENERALISED TONIC-CLONIC SEIZURE	85
33	KIDNEY STONES	83
34	CONFUSIONAL STATE	81
35	ABNORMAL BEHAVIOUR	79
36	OVERDOSE	79
37	PAIN IN EXTREMITY	79
38	DRUG HYPERSENSITIVITY	78
39	PNEUMONIA	78
40	GAIT DISTURBANCE	77
41	SUICIDAL IDEATION	77
42	DRUG DOSE OMISSION	76
43	LOSS OF CONSCIOUSNESS	74
44	MEMORY IMPAIRMENT	74
45	BALANCE DISORDER	73
46	MIGRAINE	71
47	JOINT PAIN	68
48	CONSTIPATION	68
49	IRRITABILITY	68
50	VISION BLURRED	68
51	AGITATION	65
52	CHEST PAIN	63
53	BACK PAIN	60
54	HALLUCINATION	60
55	MUSCLE SPASMS	60
56	PRODUCT DOSE OMISSION ISSUE	60
57	ITCHING	60
58	AMNESIA	59
59	DEATH	59
60	ABDOMINAL PAIN UPPER	57
61	HAIR LOSS	57
62	FOETAL EXPOSURE DURING PREGNANCY	56
63	HYPERSENSITIVITY	56
64	URINARY TRACT INFECTION	56
65	GRAND MAL CONVULSION	55
66	NUMBNESS	53
67	PSYCHOTIC DISORDER	52
68	COMMUNICATION DISORDER (APHASIA)	49
69	COUGH	48
70	ATAXIA	47
71	PRODUCT SUBSTITUTION ISSUE	47
72	ABDOMINAL PAIN	45
73	ENCEPHALOPATHY	45
74	HIGH BLOOD PRESSURE	45
75	LETHARGY	45
76	BRUISE	44
77	LOW BLOOD PRESSURE	44
78	PRODUCT USE IN UNAPPROVED INDICATION	44
79	SUICIDE ATTEMPT	43
80	MATERNAL EXPOSURE DURING PREGNANCY	42
81	PINS AND NEEDLES	42
82	SPEECH DISORDER	42
83	DEHYDRATION	41
84	DISTURBANCE IN ATTENTION	41
85	DRUG EXPOSURE DURING PREGNANCY	41
86	MUSCULAR WEAKNESS	41
87	COMMON COLD	41
88	ABDOMINAL DISCOMFORT	39
89	ANGER	39
90	DEVELOPMENTAL DELAY	39
91	SLURRED SPEECH	39
92	VISUAL IMPAIRMENT	38
93	DOUBLE VISION	36
94	HOSPITALIZATION	36
95	MUSCLE PAIN	36
96	PREMATURE BABY	36
97	PALPITATIONS	35
98	PRODUCT USE ISSUE	35
99	STROKE	34
100	DIABETES MELLITUS	34

Latest Known Outcomes for Reactions Reported for ZONEGRAN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1909
2	Patient recovered	889
3	Patient has not recovered/symtoms have not resolved	750
4	Patient is recovering/symptoms resolving	347
5	Patient died	124
6	Patient has recovered but has consequent health issues	14

Search all MedWatch and FAERS by keyword:

ZONEGRAN Total Reports

Male	Female	Unknown	Total
1384	2422	503	4,309

Top Countries Reporting

	Country	Number of Reports
1	United States	2156
2	France	284
3	Germany	148
4	United Kingdom	67
5	Spain	52
6	Italy	51
7	Sweden	31
8	Japan	28
9	Portugal	25
10	EU	18

Outcomes for Reports

Serious: 3150
Not Serious: 1159
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

Partial seizures

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 2000-03-27

ZONEGRAN (ZONISAMIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with ZONEGRAN? Rate ZONEGRAN 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

This report, created by AskaPatient.com, is derived from the cases for ZONEGRAN 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.