FDA Adverse Events Reports (FAERS) Summary for CAMBIA

These tables and charts are based on 2,096 total reports for CAMBIA (DICLOFENAC POTASSIUM) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 2,044 pharmaceutical company-submitted and non-U.S. FAERS reports and 52 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 52 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch CAMBIA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	429
2	MIGRAINE	195
3	PRODUCT USE IN UNAPPROVED INDICATION	171
4	NAUSEA	148
5	HEADACHE	142
6	FATIGUE	137
7	OFF LABEL USE	135
8	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	125
9	PAIN	112
10	PRODUCT USE ISSUE	108
11	MALAISE	93
12	DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE	91
13	VOMITING	90
14	DIZZINESS	79
15	CONDITION AGGRAVATED	71
16	FALL	67
17	ABDOMINAL DISCOMFORT	55
18	JOINT SWELLING	55
19	BRUISE	54
20	DROWSINESS	52
21	RHEUMATOID ARTHRITIS	49
22	ILLNESS	45
23	OSTEOARTHRITIS	45
24	RASH	44
25	PRODUCT QUALITY ISSUE	43
26	SPINAL STENOSIS	43
27	TENDERNESS	43
28	GRIP STRENGTH DECREASED	42
29	TREATMENT FAILURE	42
30	INSOMNIA	41
31	ABDOMINAL PAIN UPPER	39
32	DRUG PRESCRIBING ERROR	36
33	FEELING ABNORMAL	36
34	PRODUCT TASTE ABNORMAL	36
35	JOINT PAIN	34
36	BLOOD PRESSURE INCREASED	33
37	DEPRESSION	33
38	DIARRHEA	31
39	ANXIETY	30
40	BACK PAIN	30
41	ITCHING	30
42	DRUG EFFECT DECREASED	29
43	PINS AND NEEDLES	29
44	INJECTION SITE PAIN	28
45	WEIGHT DECREASED	28
46	LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES	27
47	SINUSITIS	27
48	COMMON COLD	26
49	HYPERSENSITIVITY	25
50	PRODUCT DOSE OMISSION ISSUE	25
51	HAIR LOSS	24
52	SHORTNESS OF BREATH	23
53	LACK OF STRENGTH AND ENERGY (ASTHENIA)	22
54	CHEST PAIN	22
55	PAIN IN EXTREMITY	22
56	COUGH	21
57	INDIGESTION	21
58	PNEUMONIA	21
59	MUSCLE SPASMS	20
60	ASTHMA	19
61	DRUG HYPERSENSITIVITY	19
62	HIGH BLOOD PRESSURE	19
63	PALPITATIONS	19
64	SUN SENSITIVITY REACTION	19
65	FEVER	19
66	WEIGHT INCREASED	19
67	DEATH	18
68	DRUG INTOLERANCE	18
69	NECK PAIN	18
70	SUICIDAL IDEATION	18
71	ABDOMINAL PAIN	17
72	BRONCHITIS	17
73	GAIT DISTURBANCE	17
74	GASTROOESOPHAGEAL REFLUX DISEASE	17
75	MEMORY IMPAIRMENT	17
76	FAINTING	17
77	CONSTIPATION	16
78	NUMBNESS	16
79	MUSCULOSKELETAL STIFFNESS	16
80	LOWER LIMBS SWELLING	16
81	PRE-EXISTING CONDITION IMPROVED	16
82	HIVES	16
83	VISION BLURRED	16
84	EXCESS SWEATING	15
85	INTENTIONAL PRODUCT USE ISSUE	15
86	MUSCULAR WEAKNESS	15
87	SENSITIVITY TO LIGHT	15
88	ROTATOR CUFF REPAIR	15
89	SEIZURE	15
90	DRY EYE	14
91	SLURRED SPEECH	14
92	DIFFICULTY SWALLOWING	14
93	ILL-DEFINED DISORDER	14
94	STRESS	14
95	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	13
96	ARTHRITIS	12
97	COVID-19	12
98	IMMUNODEFICIENCY	12
99	INFLUENZA	12
100	LOSS OF CONSCIOUSNESS	12

Latest Known Outcomes for Reactions Reported for CAMBIA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1441
2	Patient has not recovered/symtoms have not resolved	546
3	Patient recovered	355
4	Patient is recovering/symptoms resolving	123
5	Patient died	29
6	Patient has recovered but has consequent health issues	4

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2010	3
2011	3
2012	8
2013	18
2014	20
2015	107
2016	609
2017	302
2018	171
2019	282
2020	226
2021	97
2022	64
2023	44
2024	64
2025	49
2026	29

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	4
11-20	110
21-30	127
31-40	191
41-50	233
51-60	246
61-70	145
71-80	27
81-90	3
91+	3

Based on 1089 reports that included a patient age.

CAMBIA Total Reports

Male	Female	Unknown	Total
222	1412	462	2,096

Top Countries Reporting

	Country	Number of Reports
1	United States	1858
2	Canada	216
3	Brazil	1

Outcomes for Reports

Serious: 700
Not Serious: 1395
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

TEVA
AUROBINDO
ASSERTIO THERAPEUTICS
APOTEX

Safety-Related FDA Updates

FDA Approval Date: 2009-06-17

CAMBIA (DICLOFENAC POTASSIUM) Rx Drug:
Safety-related Labeling Changes

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