FDA Adverse Events Reports (FAERS) Summary for CIPRO

These tables and charts are based on 21,846 total reports for CIPRO (CIPROFLOXACIN HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 20,099 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,747 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 1,747 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch CIPRO summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG HYPERSENSITIVITY	2521
2	PAIN	1701
3	NAUSEA	1536
4	DIARRHEA	1493
5	NEUROPATHY PERIPHERAL	1486
6	JOINT PAIN	1479
7	FATIGUE	1447
8	URINARY TRACT INFECTION	1102
9	HEADACHE	1070
10	SHORTNESS OF BREATH	1068
11	PAIN IN EXTREMITY	1056
12	DRUG INEFFECTIVE	984
13	LACK OF STRENGTH AND ENERGY (ASTHENIA)	981
14	ANXIETY	976
15	DIZZINESS	944
16	RASH	871
17	VOMITING	852
18	OFF LABEL USE	840
19	FEVER	836
20	ABDOMINAL PAIN	788
21	MALAISE	775
22	WEIGHT DECREASED	669
23	BACK PAIN	647
24	DEPRESSION	638
25	NUMBNESS	638
26	PNEUMONIA	636
27	INSOMNIA	630
28	PINS AND NEEDLES	606
29	COUGH	591
30	GAIT DISTURBANCE	568
31	DEATH	558
32	ITCHING	557
33	FALL	555
34	KIDNEY FAILURE	551
35	MUSCLE PAIN	526
36	ABDOMINAL PAIN UPPER	519
37	CHRONIC KIDNEY DISEASE	507
38	HIGH BLOOD PRESSURE	483
39	CONDITION AGGRAVATED	478
40	TENDONITIS	471
41	FEELING ABNORMAL	468
42	ACUTE KIDNEY INJURY	463
43	DEHYDRATION	454
44	CHEST PAIN	452
45	CONSTIPATION	449
46	MUSCLE SPASMS	449
47	DECREASED APPETITE	446
48	INJURY	440
49	HYPERSENSITIVITY	420
50	MUSCULAR WEAKNESS	413
51	ABDOMINAL DISCOMFORT	401
52	TENDON RUPTURE	397
53	CONFUSIONAL STATE	396
54	ANEMIA	384
55	INFECTION	383
56	SINUSITIS	368
57	HIVES	367
58	LOW BLOOD PRESSURE	350
59	EMOTIONAL DISTRESS	348
60	SWELLING OF LIMBS	342
61	TENDON PAIN	342
62	TREMOR	340
63	WEIGHT INCREASED	329
64	BURNING SENSATION	321
65	LOWER LIMBS SWELLING	313
66	JOINT SWELLING	307
67	TENDON DISORDER	302
68	CHILLS	300
69	PALPITATIONS	300
70	VISION BLURRED	300
71	BLOOD PRESSURE INCREASED	292
72	SKIN REDNESS	292
73	SEPSIS	288
74	COMMON COLD	278
75	HAEMOGLOBIN DECREASED	271
76	CYSTITIS	264
77	DRUG INTERACTION	262
78	MUSCULOSKELETAL PAIN	259
79	CONGESTIVE HEART FAILURE	258
80	RINGING IN THE EARS	257
81	CROHN^S DISEASE	254
82	HAIR LOSS	249
83	BRONCHITIS	243
84	PRODUCT USE ISSUE	243
85	ABDOMINAL DISTENSION	238
86	GASTROINTESTINAL DISORDER	237
87	MEMORY IMPAIRMENT	237
88	GASTROOESOPHAGEAL REFLUX DISEASE	234
89	BALANCE DISORDER	226
90	HEART ATTACK (MYOCARDIAL INFARCTION)	224
91	BRUISE	215
92	INDIGESTION	215
93	EXCESS SWEATING	214
94	DIVERTICULITIS	210
95	DROWSINESS	210
96	STROKE	206
97	DIFFICULTY SWALLOWING	206
98	WHITE BLOOD CELL COUNT DECREASED	206
99	DRUG INTOLERANCE	205
100	HALLUCINATION	202

Latest Known Outcomes for Reactions Reported for CIPRO

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	8344
2	Patient has not recovered/symtoms have not resolved	4124
3	Patient recovered	3220
4	Patient is recovering/symptoms resolving	1572
5	Patient died	950
6	Patient has recovered but has consequent health issues	116

CIPRO Total Reports

Male	Female	Unknown	Total
6789	13169	1888	21,846

Top Countries Reporting

	Country	Number of Reports
1	United States	15003
2	Canada	1487
3	Germany	186
4	Brazil	64
5	Turkey	53
6	Puerto Rico	22
7	United Kingdom	21
8	Portugal	19
9	Colombia	8
10	France	8

Outcomes for Reports

Serious: 14458
Not Serious: 7385
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

Urinary tract infection
Kidney infection
Dementia
Cystitis
Colon operation

Top Companies Reporting

BAYER HEALTHCARE PHARMACEUTICALS INC.
RANBAXY
BAYER
HIKMA
SANDOZ
FDC LIMITED
ANI
DR REDDYS
TEVA
BAYER HEALTHCARE PHARMACEUTICALS INC.

Safety-Related FDA Updates

FDA Approval Date: 1987-10-22

CIPRO (CIPROFLOXACIN HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CIPRO? Rate CIPRO at Ask a Patient.

CIPRO (CIPROFLOXACIN HYDROCHLORIDE) Rx Drug:
Risk of mitral and aortic regurgitationEvaluating Safety-related Labeling Changes

Have experience (good or bad) with CIPRO? Rate CIPRO at Ask a Patient.

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER (CIPROFLOXACIN) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER? Rate CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER at Ask a Patient.

CILOXAN (CIPROFLOXACIN HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CILOXAN? Rate CILOXAN at Ask a Patient.

CIPRO HC (CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CIPRO HC? Rate CIPRO HC at Ask a Patient.

CIPRO XR (CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CIPRO XR? Rate CIPRO XR at Ask a Patient.

CIPRO XR (CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE) Rx Drug:
Risk of mitral and aortic regurgitationEvaluating Safety-related Labeling Changes

Have experience (good or bad) with CIPRO XR? Rate CIPRO XR at Ask a Patient.

CIPRODEX (CIPROFLOXACIN; DEXAMETHASONE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CIPRODEX? Rate CIPRODEX at Ask a Patient.

OTIPRIO (CIPROFLOXACIN) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with OTIPRIO? Rate OTIPRIO 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 CIPRO 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.