FDA Adverse Events Reports (FAERS) Summary for IBSRELA

These tables and charts are based on 3,160 total reports for IBSRELA (TENAPANOR HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 3,053 pharmaceutical company-submitted and non-U.S. FAERS reports and 107 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 107 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch IBSRELA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DIARRHEA	1154
2	PRODUCT USE ISSUE	430
3	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	388
4	THERAPY INTERRUPTED	292
5	PRODUCT USE IN UNAPPROVED INDICATION	249
6	ABDOMINAL DISTENSION	231
7	DRUG INEFFECTIVE	209
8	INSURANCE ISSUE	184
9	INTENTIONAL UNDERDOSE	167
10	OFF LABEL USE	165
11	ABDOMINAL PAIN UPPER	159
12	NAUSEA	136
13	FLATULENCE	129
14	ABDOMINAL PAIN	128
15	UNDERDOSE	123
16	DIZZINESS	90
17	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	90
18	ABDOMINAL DISCOMFORT	87
19	ILLNESS	85
20	PAIN	84
21	UNEVALUABLE EVENT	83
22	DEHYDRATION	70
23	PRESCRIBED UNDERDOSE	68
24	CONSTIPATION	65
25	VOMITING	62
26	HOSPITALIZATION	59
27	ADVERSE DRUG REACTION	55
28	MALAISE	54
29	HEADACHE	49
30	PRODUCT DOSE OMISSION ISSUE	49
31	INTENTIONAL DOSE OMISSION	48
32	WEIGHT DECREASED	48
33	GASTROINTESTINAL SOUNDS ABNORMAL	46
34	FATIGUE	42
35	CONDITION AGGRAVATED	41
36	MUSCLE SPASMS	41
37	PRODUCT DISTRIBUTION ISSUE	40
38	DRUG INTOLERANCE	39
39	PRODUCT DOSE OMISSION IN ERROR	37
40	ANAL INCONTINENCE	36
41	INABILITY TO AFFORD MEDICATION	35
42	THERAPEUTIC PRODUCT EFFECT DECREASED	35
43	SHORTNESS OF BREATH	34
44	FREQUENT BOWEL MOVEMENTS	33
45	THERAPY CESSATION	32
46	FALL	31
47	FEELING ABNORMAL	31
48	THERAPEUTIC PRODUCT EFFECT VARIABLE	31
49	GASTROINTESTINAL DISORDER	28
50	SURGERY	28
51	NO ADVERSE EVENT	27
52	DEATH	25
53	GASTROOESOPHAGEAL REFLUX DISEASE	25
54	DECREASED APPETITE	24
55	INDIGESTION	24
56	RASH	24
57	ADVERSE EVENT	23
58	LACK OF STRENGTH AND ENERGY (ASTHENIA)	23
59	HAEMORRHOIDS	23
60	ITCHING	23
61	GASTROINTESTINAL MOTILITY DISORDER	22
62	RECTAL BLEEDING	21
63	DRUG EFFECT INCOMPLETE	21
64	TREATMENT NONCOMPLIANCE	21
65	URINARY TRACT INFECTION	21
66	WEIGHT INCREASED	19
67	ANXIETY	18
68	BACK PAIN	18
69	DISCOMFORT	18
70	INSOMNIA	18
71	FAECALOMA	17
72	COUGH	16
73	INTESTINAL OBSTRUCTION	16
74	PRODUCT PRESCRIBING ISSUE	16
75	CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR	15
76	COLONOSCOPY	15
77	DRUG EFFECT DECREASED	15
78	IMPAIRED GASTRIC EMPTYING	15
79	INFLUENZA	15
80	ABDOMINAL PAIN LOWER	14
81	HYPERSENSITIVITY	14
82	MEMORY IMPAIRMENT	14
83	PRODUCT COMMUNICATION ISSUE	14
84	ABNORMAL FAECES	13
85	JOINT PAIN	13
86	BLOOD POTASSIUM DECREASED	13
87	BLOOD SODIUM DECREASED	13
88	DIFFICULTY SWALLOWING	13
89	IRRITABLE BOWEL SYNDROME	13
90	BOWEL MOVEMENT IRREGULARITY	12
91	BRAIN FOG	12
92	COVID-19	12
93	FAECES DISCOLOURED	12
94	FEEDING DISORDER	12
95	INJECTION SITE PAIN	12
96	LOSS OF CONSCIOUSNESS	12
97	COMMON COLD	12
98	PAIN IN EXTREMITY	12
99	PRODUCT AVAILABILITY ISSUE	12
100	HIVES	11

Latest Known Outcomes for Reactions Reported for IBSRELA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2707
2	Patient recovered	599
3	Patient is recovering/symptoms resolving	243
4	Patient has not recovered/symtoms have not resolved	226
5	Patient died	27

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2016	1
2017	1
2019	2
2020	2
2021	1
2022	42
2023	103
2024	204
2025	343
2026	2461

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	1
11-20	10
21-30	55
31-40	65
41-50	141
51-60	188
61-70	245
71-80	223
81-90	66
91+	8

Based on 1002 reports that included a patient age.

IBSRELA Total Reports

Male	Female	Unknown	Total
481	2517	162	3,160

Top Countries Reporting

	Country	Number of Reports
1	United States	3140
2	Canada	18
3	Japan	2

Outcomes for Reports

Serious: 622
Not Serious: 2537
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

Irritable bowel syndrome
Constipation

Top Companies Reporting

ARDELYX

Safety-Related FDA Updates

FDA Approval Date: 2019-09-12

IBSRELA (TENAPANOR HYDROCHLORIDE) Rx Drug:
Hypersensitivity reactions including fever, rash, itching Safety-related Labeling Changes

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