FDA Adverse Events Reports (FAERS) Summary for CAMBIA

These tables and charts are based on 2,073 total reports for CAMBIA (DICLOFENAC POTASSIUM) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 2,021 pharmaceutical company-submitted and non-U.S. FAERS reports and 52 U.S. consumer or healthcare provider-submitted MedWatch reports. 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	428
2	MIGRAINE	189
3	PRODUCT USE IN UNAPPROVED INDICATION	171
4	NAUSEA	148
5	HEADACHE	141
6	FATIGUE	135
7	OFF LABEL USE	133
8	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	125
9	PAIN	113
10	PRODUCT USE ISSUE	106
11	DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE	91
12	VOMITING	90
13	MALAISE	88
14	DIZZINESS	78
15	CONDITION AGGRAVATED	70
16	FALL	66
17	ABDOMINAL DISCOMFORT	55
18	BRUISE	54
19	DROWSINESS	52
20	JOINT SWELLING	50
21	RHEUMATOID ARTHRITIS	49
22	OSTEOARTHRITIS	45
23	PRODUCT QUALITY ISSUE	43
24	SPINAL STENOSIS	43
25	TENDERNESS	43
26	GRIP STRENGTH DECREASED	42
27	ILLNESS	42
28	TREATMENT FAILURE	42
29	INSOMNIA	41
30	ABDOMINAL PAIN UPPER	39
31	RASH	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	31
38	DIARRHEA	31
39	ANXIETY	30
40	BACK PAIN	29
41	DRUG EFFECT DECREASED	29
42	PINS AND NEEDLES	29
43	ITCHING	28
44	INJECTION SITE PAIN	27
45	LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES	27
46	HYPERSENSITIVITY	25
47	COMMON COLD	25
48	SINUSITIS	25
49	PRODUCT DOSE OMISSION ISSUE	24
50	SHORTNESS OF BREATH	23
51	WEIGHT DECREASED	23
52	LACK OF STRENGTH AND ENERGY (ASTHENIA)	21
53	INDIGESTION	21
54	PAIN IN EXTREMITY	21
55	COUGH	20
56	PNEUMONIA	20
57	HAIR LOSS	19
58	ASTHMA	19
59	DRUG HYPERSENSITIVITY	19
60	HIGH BLOOD PRESSURE	19
61	PALPITATIONS	19
62	FEVER	19
63	WEIGHT INCREASED	19
64	DEATH	18
65	DRUG INTOLERANCE	18
66	MUSCLE SPASMS	18
67	NECK PAIN	18
68	SUICIDAL IDEATION	18
69	ABDOMINAL PAIN	17
70	BRONCHITIS	17
71	CHEST PAIN	17
72	GAIT DISTURBANCE	17
73	GASTROOESOPHAGEAL REFLUX DISEASE	17
74	MEMORY IMPAIRMENT	17
75	FAINTING	17
76	CONSTIPATION	16
77	NUMBNESS	16
78	MUSCULOSKELETAL STIFFNESS	16
79	LOWER LIMBS SWELLING	16
80	PRE-EXISTING CONDITION IMPROVED	16
81	VISION BLURRED	16
82	EXCESS SWEATING	15
83	INTENTIONAL PRODUCT USE ISSUE	15
84	MUSCULAR WEAKNESS	15
85	SENSITIVITY TO LIGHT	15
86	SEIZURE	15
87	HIVES	15
88	SLURRED SPEECH	14
89	DIFFICULTY SWALLOWING	14
90	ILL-DEFINED DISORDER	14
91	SUN SENSITIVITY REACTION	14
92	ROTATOR CUFF REPAIR	14
93	STRESS	14
94	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	13
95	COVID-19	12
96	DRY EYE	12
97	IMMUNODEFICIENCY	12
98	INFLUENZA	12
99	LOSS OF CONSCIOUSNESS	12
100	KIDNEY STONES	12

Latest Known Outcomes for Reactions Reported for CAMBIA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1425
2	Patient has not recovered/symtoms have not resolved	536
3	Patient recovered	350
4	Patient is recovering/symptoms resolving	121
5	Patient died	29
6	Patient has recovered but has consequent health issues	4

Search all MedWatch and FAERS by keyword:

CAMBIA Total Reports

Male	Female	Unknown	Total
221	1393	459	2,073

Top Countries Reporting

	Country	Number of Reports
1	United States	1854
2	Canada	202
3	Brazil	1

Outcomes for Reports

Serious: 679
Not Serious: 1393
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

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 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.