FDA Adverse Events Reports (FAERS) Summary for QUESTRAN

These tables and charts are based on 2,883 total reports for QUESTRAN (CHOLESTYRAMINE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 2,820 pharmaceutical company-submitted and non-U.S. FAERS reports and 63 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 63 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch QUESTRAN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DIARRHEA	408
2	NAUSEA	207
3	FATIGUE	199
4	ABDOMINAL PAIN	161
5	VOMITING	142
6	SHORTNESS OF BREATH	136
7	LACK OF STRENGTH AND ENERGY (ASTHENIA)	135
8	DRUG INEFFECTIVE	129
9	DEHYDRATION	117
10	HEADACHE	112
11	JOINT PAIN	111
12	OFF LABEL USE	111
13	FEVER	111
14	PAIN	109
15	ACUTE KIDNEY INJURY	96
16	WEIGHT DECREASED	94
17	DEATH	93
18	DIZZINESS	92
19	ANEMIA	86
20	ITCHING	86
21	PNEUMONIA	82
22	URINARY TRACT INFECTION	81
23	FALL	79
24	DECREASED APPETITE	75
25	CONSTIPATION	74
26	MALAISE	73
27	RASH	70
28	PAIN IN EXTREMITY	68
29	THROMBOCYTOPENIA	68
30	ABDOMINAL PAIN UPPER	65
31	CROHN^S DISEASE	65
32	COUGH	64
33	KIDNEY FAILURE	63
34	INSOMNIA	62
35	BACK PAIN	61
36	ANXIETY	60
37	MUSCLE PAIN	60
38	CHEST PAIN	56
39	DEPRESSION	53
40	HIGH BLOOD PRESSURE	53
41	MUSCLE SPASMS	53
42	SEPSIS	53
43	LOW BLOOD PRESSURE	51
44	ABDOMINAL DISTENSION	50
45	SWELLING OF LIMBS	50
46	INJECTION SITE PAIN	48
47	ALT LIVER ENZYME INCREASED	47
48	BLOOD PRESSURE INCREASED	47
49	HAEMOGLOBIN DECREASED	47
50	RECTAL BLEEDING	44
51	SKIN REDNESS	43
52	ASPARTATE AMINOTRANSFERASE INCREASED	42
53	CONDITION AGGRAVATED	42
54	FEELING ABNORMAL	42
55	GAIT DISTURBANCE	41
56	HAIR LOSS	40
57	PANCREATITIS	38
58	RENAL FAILURE ACUTE	38
59	CHILLS	37
60	DRUG HYPERSENSITIVITY	37
61	INDIGESTION	37
62	LOWER LIMBS SWELLING	37
63	CONFUSIONAL STATE	36
64	MUSCULAR WEAKNESS	36
65	WHITE BLOOD CELL COUNT DECREASED	36
66	ABDOMINAL DISCOMFORT	35
67	PINS AND NEEDLES	35
68	GASTROINTESTINAL BLEEDING	34
69	PLATELET COUNT DECREASED	34
70	BLOOD ALKALINE PHOSPHATASE INCREASED	33
71	NUMBNESS	33
72	COMMON COLD	33
73	PRODUCT USE ISSUE	33
74	DIFFICULTY SWALLOWING	32
75	LOW WHITE BLOOD CELL COUNTS	32
76	HIVES	32
77	WEIGHT INCREASED	32
78	GASTROOESOPHAGEAL REFLUX DISEASE	31
79	GENERAL PHYSICAL HEALTH DETERIORATION	31
80	NEUROPATHY PERIPHERAL	31
81	PULMONARY EMBOLISM	30
82	ATRIAL FIBRILLATION	29
83	BRUISE	29
84	HYPOKALAEMIA	29
85	INFECTION	29
86	KIDNEY STONES	29
87	CHRONIC KIDNEY DISEASE	28
88	EOSINOPHILIA	28
89	FLATULENCE	28
90	FAINTING	28
91	CONGESTIVE HEART FAILURE	27
92	GALLSTONES	27
93	DRUG INTERACTION	27
94	ECZEMA	27
95	THROAT PAIN	27
96	TREMOR	27
97	FLUSHING	26
98	PALPITATIONS	26
99	BLOOD BILIRUBIN INCREASED	25
100	BLOOD GLUCOSE INCREASED	25

Latest Known Outcomes for Reactions Reported for QUESTRAN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1117
2	Patient recovered	789
3	Patient has not recovered/symtoms have not resolved	682
4	Patient is recovering/symptoms resolving	341
5	Patient died	211
6	Patient has recovered but has consequent health issues	29

Search all MedWatch and FAERS by keyword:

QUESTRAN Total Reports

Male	Female	Unknown	Total
1124	1606	153	2,883

Top Countries Reporting

	Country	Number of Reports
1	United States	1280
2	France	308
3	Canada	128
4	United Kingdom	62
5	Italy	52
6	Netherlands	48
7	Belgium	36
8	EU	26
9	Sweden	23
10	Australia	21

Outcomes for Reports

Serious: 2143
Not Serious: 739
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

TAKEDA

Safety-Related FDA Updates

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 QUESTRAN 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.