Drug

Diclofenac Sodium/misoprostol

47 flagged reaction(s) · 1,139 total co-reports · max PRR 187.2

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Red Blood Cell Sedimentation Rate Increased	43	187.2	207.5	signal
2	Secretion Discharge	43	167.9	186.2	signal
3	Platelet Count Increased	43	158.8	176.1	signal
4	Pulmonary Mass	31	100.5	108.1	signal
5	Skin Laceration	19	84.7	88.6	signal
6	Blood Iron Decreased	18	73.5	76.7	signal
7	Helicobacter Infection	15	70.9	73.3	signal
8	Tooth Abscess	15	70.7	73.2	signal
9	Pharyngitis	17	65.7	68.3	signal
10	Staphylococcal Infection	43	62.5	69.3	signal
11	Ankylosing Spondylitis	16	59.1	61.3	signal
12	Lower Respiratory Tract Infection	55	58.4	66.7	signal
13	Pemphigus	13	50.3	51.9	signal
14	Blood Pressure Fluctuation	23	46.0	48.5	signal
15	Blood Pressure Systolic Increased	17	41.8	43.4	signal
16	Therapeutic Product Effect Incomplete	60	40.8	47.2	signal
17	Pericarditis	14	40.4	41.7	signal
18	Sleep Apnoea Syndrome	16	40.3	41.8	signal
19	Ear Pain	16	39.6	41.1	signal
20	Drug Intolerance	78	39.0	47.3	signal
21	Synovitis	12	32.0	32.9	signal
22	Viral Infection	21	30.4	31.9	signal
23	Localised Infection	15	29.8	30.9	signal
24	Hand Deformity	8	29.4	30.0	signal
25	Irritable Bowel Syndrome	13	29.3	30.1	signal
26	Body Temperature Increased	12	28.2	29.0	signal
27	Delusion	9	28.0	28.5	signal
28	Infection	82	27.4	33.5	signal
29	Arthritis	44	26.9	29.8	signal
30	Liver Injury	13	25.9	26.6	signal
31	Therapeutic Response Shortened	17	25.7	26.7	signal
32	Impaired Work Ability	11	24.7	25.3	signal
33	Drug Hypersensitivity	98	24.3	31.0	signal
34	Wound	14	24.2	25.0	signal
35	Toothache	9	23.9	24.4	signal
36	Rheumatoid Arthritis	51	21.7	24.4	signal
37	Contraindicated Product Administered	12	19.1	19.7	signal
38	Pain In Jaw	11	18.7	19.1	signal
39	Systemic Lupus Erythematosus	13	17.7	18.2	signal
40	Product Complaint	9	17.3	17.7	signal
41	Psoriatic Arthropathy	14	16.7	17.3	signal
42	Dementia	9	15.5	15.9	signal
43	Therapeutic Product Effect Decreased	14	15.2	15.6	signal
44	Disease Recurrence	15	15.1	15.6	signal
45	Internal Haemorrhage	3	12.6	12.7	signal
46	Procedural Pain	7	12.2	12.4	signal
47	Drug Effect Incomplete	8	10.4	10.6	signal