FDA Adverse Events Reports (FAERS) Summary for TAGAMET

These tables and charts are based on 5,153 total reports for TAGAMET (CIMETIDINE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 5,097 pharmaceutical company-submitted and non-U.S. FAERS reports and 56 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 56 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch TAGAMET summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	CHRONIC KIDNEY DISEASE	1397
2	ACUTE KIDNEY INJURY	746
3	KIDNEY FAILURE	685
4	KIDNEY FAILURE	388
5	DRUG INEFFECTIVE	352
6	NAUSEA	333
7	GASTROOESOPHAGEAL REFLUX DISEASE	318
8	KIIDNEY INJURY	301
9	DIARRHEA	263
10	VOMITING	261
11	FATIGUE	259
12	DEATH	256
13	PAIN	245
14	SHORTNESS OF BREATH	242
15	DEPRESSION	233
16	DIZZINESS	199
17	ANXIETY	188
18	HEADACHE	177
19	OSTEOPOROSIS	176
20	OFF LABEL USE	175
21	CONSTIPATION	154
22	RASH	153
23	CHEST PAIN	150
24	BACK PAIN	149
25	LACK OF STRENGTH AND ENERGY (ASTHENIA)	146
26	MALAISE	145
27	JOINT PAIN	142
28	HIGH BLOOD PRESSURE	142
29	NEPHROGENIC ANAEMIA	137
30	FEVER	137
31	FALL	136
32	INDIGESTION	134
33	TUBULOINTERSTITIAL NEPHRITIS	134
34	ITCHING	133
35	ABDOMINAL PAIN UPPER	131
36	ARTHRITIS	127
37	ABDOMINAL PAIN	126
38	ANEMIA	121
39	WEIGHT DECREASED	116
40	PNEUMONIA	115
41	INSOMNIA	114
42	PAIN IN EXTREMITY	106
43	SKIN REDNESS	103
44	DECREASED APPETITE	101
45	REBOUND ACID HYPERSECRETION	101
46	KIDNEY IMPAIRMENT	101
47	BONE DISORDER	98
48	MULTIPLE FRACTURES	96
49	MUSCLE SPASMS	91
50	OSTEOARTHRITIS	89
51	COUGH	88
52	HEART ATTACK (MYOCARDIAL INFARCTION)	88
53	SWELLING OF LIMBS	88
54	NUMBNESS	81
55	ABDOMINAL DISCOMFORT	79
56	HAIR LOSS	78
57	HYPERSENSITIVITY	78
58	HIVES	76
59	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	74
60	DEHYDRATION	74
61	DRUG HYPERSENSITIVITY	73
62	LOW BLOOD PRESSURE	73
63	DIABETES MELLITUS	72
64	HYPERPARATHYROIDISM SECONDARY	69
65	CONDITION AGGRAVATED	67
66	FOOT FRACTURE	67
67	GAIT DISTURBANCE	67
68	STROKE	66
69	DISEASE PROGRESSION	66
70	INJURY	66
71	EXCESS SWEATING	65
72	ABDOMINAL DISTENSION	62
73	URINARY TRACT INFECTION	62
74	DIFFICULTY SWALLOWING	60
75	PLEURAL EFFUSION	60
76	OSTEOPENIA	59
77	EMOTIONAL DISTRESS	58
78	BLOOD PRESSURE INCREASED	57
79	CATARACT	55
80	CHEST DISCOMFORT	54
81	FEELING ABNORMAL	53
82	RESPIRATORY FAILURE	53
83	VISION BLURRED	53
84	VITAMIN D DEFICIENCY	53
85	NEUROPATHY PERIPHERAL	52
86	PINS AND NEEDLES	52
87	BRONCHITIS	51
88	CONGESTIVE HEART FAILURE	51
89	KIDNEY DAMAGE	51
90	JOINT PAIN	50
91	BONE PAIN	50
92	CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER	50
93	INTERVERTEBRAL DISC PROTRUSION	50
94	MUSCLE PAIN	50
95	PLATELET COUNT DECREASED	50
96	DROWSINESS	50
97	LOSS OF CONSCIOUSNESS	49
98	SEPSIS	49
99	TREMOR	49
100	WEIGHT INCREASED	49

Latest Known Outcomes for Reactions Reported for TAGAMET

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2058
2	Patient has not recovered/symtoms have not resolved	1675
3	Patient recovered	513
4	Patient died	404
5	Patient is recovering/symptoms resolving	245
6	Patient has recovered but has consequent health issues	26

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2003	2
2004	217
2005	357
2006	250
2007	211
2008	179
2009	173
2010	223
2011	210
2012	454
2013	168
2014	102
2015	185
2016	135
2017	171
2018	561
2019	866
2020	211
2021	201
2022	104
2023	64
2024	44
2025	44
2026	21

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	34
11-20	40
21-30	88
31-40	219
41-50	430
51-60	803
61-70	790
71-80	496
81-90	183
91+	34

Based on 3117 reports that included a patient age.

TAGAMET Total Reports

Male	Female	Unknown	Total
1645	2962	546	5,153

Top Countries Reporting

	Country	Number of Reports
1	United States	2905
2	Japan	127
3	South Korea	48
4	France	36
5	Germany	34
6	United Kingdom	17
7	Canada	14
8	China	7
9	Puerto Rico	5
10	Greece	4

Outcomes for Reports

Serious: 3863
Not Serious: 1290
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

Top Companies Reporting

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

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 TAGAMET 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.