FDA Adverse Events Reports (FAERS) Summary for QSYMIA

These tables and charts are based on 6,648 total reports for QSYMIA (PHENTERMINE HYDROCHLORIDE\TOPIRAMATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 6,407 pharmaceutical company-submitted and non-U.S. FAERS reports and 241 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 241 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch QSYMIA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	HEADACHE	450
2	PINS AND NEEDLES	432
3	DIZZINESS	348
4	DRY MOUTH	348
5	INSOMNIA	345
6	WEIGHT INCREASED	279
7	FEELING ABNORMAL	274
8	NAUSEA	265
9	FATIGUE	264
10	CONSTIPATION	251
11	ANXIETY	227
12	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	195
13	HAIR LOSS	194
14	NUMBNESS	190
15	DEPRESSION	188
16	VISION BLURRED	185
17	PALPITATIONS	175
18	METALLIC OR ALTERED TASTE	169
19	MALAISE	147
20	PRODUCT DOSE OMISSION ISSUE	146
21	HIGH BLOOD PRESSURE	114
22	IRRITABILITY	112
23	ADVERSE DRUG REACTION	108
24	MEMORY IMPAIRMENT	106
25	DIARRHEA	105
26	HEART RATE INCREASED	105
27	DROWSINESS	97
28	DISTURBANCE IN ATTENTION	93
29	LACK OF STRENGTH AND ENERGY (ASTHENIA)	91
30	INCORRECT DOSE ADMINISTERED	90
31	HUNGER	89
32	COVID-19	86
33	COMMON COLD	86
34	SHORTNESS OF BREATH	85
35	RASH	85
36	PREGNANCY	81
37	ITCHING	81
38	FEELING JITTERY	80
39	BLOOD PRESSURE INCREASED	79
40	VISUAL IMPAIRMENT	77
41	ADVERSE EVENT	76
42	BACK PAIN	76
43	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	74
44	VOMITING	70
45	MIGRAINE	66
46	ILLNESS	65
47	INCREASED APPETITE	64
48	OFF LABEL USE	62
49	SINUSITIS	60
50	PAIN	59
51	ABDOMINAL PAIN UPPER	58
52	DRUG INTOLERANCE	58
53	HYPERSENSITIVITY	57
54	NERVOUSNESS	57
55	KIDNEY STONES	56
56	COUGH	55
57	EYE PAIN	55
58	TASTE DISORDER	55
59	TREMOR	55
60	MOOD ALTERED	54
61	CHEST PAIN	53
62	URINARY TRACT INFECTION	51
63	JOINT PAIN	50
64	CONFUSIONAL STATE	50
65	HYPOTHYROIDISM	49
66	GASTROOESOPHAGEAL REFLUX DISEASE	48
67	MUSCLE SPASMS	48
68	PAIN IN EXTREMITY	48
69	THIRST	48
70	INDIGESTION	46
71	FOOD CRAVING	46
72	INCORRECT PRODUCT ADMINISTRATION DURATION	46
73	HIVES	46
74	FALL	45
75	THYROID DISORDER	45
76	ABDOMINAL DISCOMFORT	44
77	BRAIN FOG	44
78	MOOD SWINGS	43
79	DRUG DOSE OMISSION	42
80	SUICIDAL IDEATION	42
81	ANGLE CLOSURE GLAUCOMA	41
82	DEPRESSED MOOD	41
83	ABDOMINAL DISTENSION	40
84	DRY EYE	40
85	INFLUENZA	39
86	AGITATION	38
87	COMMUNICATION DISORDER (APHASIA)	37
88	EXCESS SWEATING	37
89	MENTAL IMPAIRMENT	37
90	ABDOMINAL PAIN	36
91	DRUG HYPERSENSITIVITY	36
92	AMNESIA	35
93	ASTHMA	35
94	CRYING	35
95	CHEST DISCOMFORT	34
96	DRUG INEFFECTIVE	34
97	FEVER	32
98	DEHYDRATION	31
99	RINGING IN THE EARS	31
100	DIABETES MELLITUS	30

Latest Known Outcomes for Reactions Reported for QSYMIA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2919
2	Patient has not recovered/symtoms have not resolved	2853
3	Patient recovered	1350
4	Patient is recovering/symptoms resolving	324
5	Patient died	13
6	Patient has recovered but has consequent health issues	11

Search all MedWatch and FAERS by keyword:

QSYMIA Total Reports

Male	Female	Unknown	Total
667	4781	1200	6,648

Top Countries Reporting

	Country	Number of Reports
1	United States	6601
2	South Korea	33
3	Canada	2
4	United Kingdom	1

Outcomes for Reports

Serious: 872
Not Serious: 5776
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
Weight decreased
Obesity
Migraine

Top Companies Reporting

VIVUS
VIVUS, INC.

Safety-Related FDA Updates

QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE) Rx Drug:
FDA Risk Evaluation and Mitigation Strategy REMS REMS

QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with QSYMIA? Rate QSYMIA 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 QSYMIA 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.