FDA Adverse Events Reports (FAERS) Summary for ARTHROTEC

These tables and charts are based on 6,653 total reports for ARTHROTEC (DICLOFENAC SODIUM\MISOPROSTOL) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 6,610 pharmaceutical company-submitted and non-U.S. FAERS reports and 43 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 43 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ARTHROTEC summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	1196
2	PAIN	904
3	JOINT PAIN	777
4	RHEUMATOID ARTHRITIS	680
5	NAUSEA	640
6	FATIGUE	555
7	DIARRHEA	522
8	DRUG HYPERSENSITIVITY	518
9	MALAISE	448
10	HEADACHE	417
11	DIZZINESS	412
12	PAIN IN EXTREMITY	377
13	JOINT SWELLING	375
14	BACK PAIN	355
15	SHORTNESS OF BREATH	335
16	LACK OF STRENGTH AND ENERGY (ASTHENIA)	327
17	FALL	323
18	INFECTION	318
19	CONDITION AGGRAVATED	299
20	COMMON COLD	296
21	ABDOMINAL DISCOMFORT	291
22	VOMITING	289
23	OFF LABEL USE	270
24	WEIGHT DECREASED	258
25	BLOOD PRESSURE INCREASED	257
26	RASH	251
27	DRUG INTOLERANCE	250
28	SWELLING	250
29	MUSCULOSKELETAL STIFFNESS	245
30	MUSCLE SPASMS	238
31	ABDOMINAL PAIN UPPER	234
32	PNEUMONIA	232
33	COUGH	229
34	HYPERSENSITIVITY	224
35	GAIT DISTURBANCE	214
36	INSOMNIA	214
37	LOWER RESPIRATORY TRACT INFECTION	212
38	ARTHRITIS	203
39	INFUSION RELATED REACTION	203
40	JOINT PAIN	198
41	ITCHING	191
42	NECK PAIN	186
43	NUMBNESS	184
44	MUSCULOSKELETAL PAIN	181
45	LUNG MASS	180
46	ANXIETY	179
47	DEPRESSION	179
48	HIGH BLOOD PRESSURE	179
49	WEIGHT INCREASED	178
50	FEELING ABNORMAL	169
51	FEVER	168
52	LOWER LIMBS SWELLING	158
53	DRUG EFFECT INCOMPLETE	156
54	HAIR LOSS	154
55	LOW BLOOD PRESSURE	152
56	INTERNATIONAL NORMALISED RATIO FLUCTUATION	152
57	ABDOMINAL PAIN	145
58	SWELLING OF LIMBS	145
59	CHEST PAIN	143
60	GASTROOESOPHAGEAL REFLUX DISEASE	137
61	DISEASE RECURRENCE	127
62	PINS AND NEEDLES	127
63	STROKE	124
64	PALPITATIONS	124
65	HEART ATTACK (MYOCARDIAL INFARCTION)	122
66	RHEUMATOID FACTOR POSITIVE	118
67	ANEMIA	117
68	OSTEOARTHRITIS	114
69	INFLUENZA	113
70	MUSCLE PAIN	113
71	THROAT PAIN	113
72	ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE	111
73	PSORIASIS	111
74	TREATMENT FAILURE	110
75	URINARY TRACT INFECTION	110
76	ELEVATED LIVER ENZYMES	109
77	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	109
78	CHILLS	103
79	CONSTIPATION	103
80	DROWSINESS	103
81	DRUG INTERACTION	102
82	OXYGEN SATURATION DECREASED	102
83	BLOODY DISCHARGE	100
84	MUSCULAR WEAKNESS	100
85	DECREASED APPETITE	97
86	KIDNEY FAILURE	97
87	INDIGESTION	96
88	BRONCHITIS	95
89	LYME DISEASE	95
90	BLOOD CHOLESTEROL INCREASED	94
91	STAPHYLOCOCCAL INFECTION	93
92	BRUISE	92
93	FLUSHING	92
94	ILL-DEFINED DISORDER	91
95	BLOOD PRESSURE HIGH	89
96	CONTRAINDICATED PRODUCT ADMINISTERED	89
97	PSORIATIC ARTHRITIS	88
98	INJECTION SITE PAIN	87
99	MOBILITY DECREASED	87
100	TREMOR	86

Latest Known Outcomes for Reactions Reported for ARTHROTEC

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2918
2	Patient has not recovered/symtoms have not resolved	1541
3	Patient recovered	827
4	Patient is recovering/symptoms resolving	428
5	Patient died	119
6	Patient has recovered but has consequent health issues	27

Search all MedWatch and FAERS by keyword:

ARTHROTEC Total Reports

Male	Female	Unknown	Total
1655	4481	517	6,653

Top Countries Reporting

	Country	Number of Reports
1	Canada	2300
2	United States	1674
3	United Kingdom	131
4	Netherlands	26
5	Norway	24
6	Sweden	22
7	Switzerland	17
8	Portugal	15
9	Germany	13
10	Denmark	13

Outcomes for Reports

Serious: 5025
Not Serious: 1627
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

Arthritis
Osteoporosis
Chondropathy

Top Companies Reporting

Safety-Related FDA Updates

ARTHROTEC (DICLOFENAC SODIUM; MISOPROSTOL) Rx Drug:
Safety-related Labeling Changes

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