FDA Adverse Events Reports (FAERS) Summary for DEMEROL

These tables and charts are based on 8,053 total reports for DEMEROL (MEPERIDINE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 7,996 pharmaceutical company-submitted and non-U.S. FAERS reports and 57 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 57 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch DEMEROL summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG HYPERSENSITIVITY	3169
2	DRUG INEFFECTIVE	1259
3	NAUSEA	1132
4	PAIN	1125
5	OFF LABEL USE	885
6	EXCESS SWEATING	854
7	DRUG INTOLERANCE	764
8	RASH	764
9	VOMITING	711
10	HIGH BLOOD PRESSURE	671
11	HEADACHE	621
12	FEVER	605
13	FATIGUE	584
14	JOINT SWELLING	568
15	RHEUMATOID ARTHRITIS	566
16	UPPER RESPIRATORY TRACT INFECTION	561
17	INFUSION RELATED REACTION	558
18	OVERDOSE	550
19	HYPERSENSITIVITY	538
20	TREATMENT FAILURE	488
21	PSORIASIS	487
22	THROMBOCYTOPENIA	484
23	INFECTION	448
24	EXPOSURE DURING PREGNANCY	436
25	SEDATION	409
26	BACK PAIN	404
27	NIGHTMARE	404
28	ASTHMA	384
29	PRODUCT USE ISSUE	383
30	DRUG DEPENDENCE	375
31	ELEVATED LIVER ENZYMES	360
32	IMMUNODEFICIENCY	359
33	FOOD ALLERGY	355
34	KIDNEY STONES	346
35	PRESCRIBED OVERDOSE	345
36	INTENTIONAL PRODUCT MISUSE	340
37	PRODUCT USE IN UNAPPROVED INDICATION	325
38	RASH ERYTHEMATOUS	325
39	CONSTIPATION	315
40	SHORTNESS OF BREATH	299
41	ANXIETY	293
42	SKIN REDNESS	288
43	FLUID RETENTION	288
44	CONTRAINDICATED PRODUCT ADMINISTERED	274
45	DIZZINESS	269
46	MALAISE	269
47	JOINT PAIN	256
48	DIARRHEA	255
49	TEMPERATURE REGULATION DISORDER	251
50	FOETAL DEATH	246
51	PAIN IN EXTREMITY	233
52	BURSITIS	229
53	CHEST PAIN	224
54	HIVES	223
55	COELIAC DISEASE	217
56	EMOTIONAL DISTRESS	213
57	SHINGLES	213
58	ABDOMINAL PAIN	200
59	ITCHING	198
60	DEPRESSION	194
61	FALL	188
62	INSOMNIA	179
63	CONTRAST MEDIA ALLERGY	177
64	LACK OF STRENGTH AND ENERGY (ASTHENIA)	173
65	INJURY	164
66	DEATH	158
67	INTERNATIONAL NORMALISED RATIO FLUCTUATION	156
68	NUMBNESS	153
69	COUGH	150
70	DRUG WITHDRAWAL SYNDROME	147
71	DRUG EFFECT INCOMPLETE	146
72	PNEUMONIA	145
73	CHILLS	144
74	WEIGHT DECREASED	137
75	ABDOMINAL PAIN UPPER	136
76	KIDNEY FAILURE	132
77	LOW BLOOD PRESSURE	126
78	DROWSINESS	120
79	FEELING ABNORMAL	118
80	WEIGHT INCREASED	117
81	SEPSIS	113
82	CONFUSIONAL STATE	112
83	TREMOR	112
84	GASTROOESOPHAGEAL REFLUX DISEASE	111
85	ANEMIA	107
86	DEHYDRATION	106
87	BLOODY DISCHARGE	105
88	SWELLING OF LIMBS	105
89	URINARY TRACT INFECTION	105
90	GAIT DISTURBANCE	101
91	LYME DISEASE	101
92	ANAPHYLACTIC REACTION	100
93	LOSS OF CONSCIOUSNESS	100
94	ABDOMINAL DISCOMFORT	99
95	MIGRAINE	98
96	PULMONARY EMBOLISM	98
97	SWELLING	96
98	DEEP VEIN THROMBOSIS	95
99	MUSCLE SPASMS	95
100	DIFFICULTY SWALLOWING	94

Latest Known Outcomes for Reactions Reported for DEMEROL

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	5265
2	Patient has not recovered/symtoms have not resolved	1191
3	Patient recovered	734
4	Patient died	390
5	Patient is recovering/symptoms resolving	243
6	Patient has recovered but has consequent health issues	37

Search all MedWatch and FAERS by keyword:

DEMEROL Total Reports

Male	Female	Unknown	Total
1818	5376	859	8,053

Top Countries Reporting

	Country	Number of Reports
1	United States	4579
2	Canada	1877
3	United Kingdom	46
4	Puerto Rico	12
5	Ireland	7
6	South Korea	6
7	Taiwan	4
8	Brazil	3
9	France	3
10	Germany	2

Outcomes for Reports

Serious: 4903
Not Serious: 3150
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

PURDUE
CELLTRION
ORGANON
PFIZER
PFIZER
BRISTOL-MYERS SQUIBB COMPANY
ALEXION PHARMACEUTICALS
TEVA
AUROBINDO
RANBAXY

Safety-Related FDA Updates

DEMEROL (MEPERIDINE HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

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