Is Ciprofloxacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 47 valid registrations of Ciprofloxacin, including BACTALL 250MG TABLET (250 mg, Film-coated tablet, SAR 12.05); BACTALL 500MG TABLET (500 mg, Film-coated tablet, SAR 23.40); CIFLOX 200MG-100ML I.V. INFUSION (200 mg, Solution for infusion, SAR 120.50); CIFLOX 250MG TABLET (250 mg, Tablet, SAR 22.85); CIFLOX 500MG TABLET (500 mg, Tablet, SAR 37.45).

Is Ciprofloxacin approved by the US FDA?

Drugs@FDA lists 66 application product lines for Ciprofloxacin, including CIPRO (Prescription); CILOXAN (Prescription); CIPRO (Prescription); CILOXAN (Prescription); CIPRO XR (Prescription).

Is Ciprofloxacin on the WHO Model List of Essential Medicines?

Yes — 28. Ear, nose and throat medicines [c] (core list): Infectious diseases of external ear.

Are there safety signals or safety updates for Ciprofloxacin?

EMA PRAC: 3 entries; US FDA: 9 entries (latest 2024-09-20).

Active substance

Ciprofloxacin

SFDA 81
US FDA 66
Health Canada 32
US price lines 10
NHS prices 7
WHO EML 2
Safety 12

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BACTALL 250MG TABLET	250 mg	Film-coated tablet · Oral use	10 Blister	SAR 12.05	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
BACTALL 500MG TABLET	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 23.40	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
CIFLOX 200MG-100ML I.V. INFUSION	200 mg	Solution for infusion · Parenteral use	1 Bag	SAR 120.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CIFLOX 250MG TABLET	250 mg	Tablet · Oral use	10 Blister	SAR 22.85	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
CIFLOX 500MG TABLET	500 mg	Tablet · Oral use	10 Blister	SAR 37.45	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
CIFOGRU 2MG/ML VIAL	2 mg/ml	Intravenous infusion · Intravenous use	1 Bag	SAR 53.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CIFOGRU 2MG/ML VIAL	2 mg/ml	Intravenous infusion · Intravenous use	1 Bag	SAR 26.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CIPRO-SOL 200MG / 100 ML Glass bottle	2 mg/ml	Solution for infusion · Parenteral use	1 Bottle	SAR 64.25	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
CIPRO-SOL 200MG /100 ML bag	2 mg/ml	Solution for infusion · Intravenous use	1 Bag	SAR 64.25	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
CIPROBAY 200 mg solution for infusion	200 mg	Solution for infusion · Parenteral use	5 Bottle	SAR 434.80	NCE · Prescription	BAYER AG	Valid
CIPROBAY 500MG TAB	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 63.85	NCE · Prescription	BAYER AG	Valid
CIPROCIN 0.3%	3 mg	Ear/eye drops, solution · Topical	1 Bottle	SAR 13.15	Generic · Prescription	RIYADH PHARMA	Valid
CIPROCIN 250MG TAB	250 mg	Film-coated tablet · Oral use	10 Blister	SAR 14.95	Generic · Prescription	EIPICO	Valid
CIPROCIN 500MG TAB	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 29.10	Generic · Prescription	EIPICO	Valid
CIPRODAR 500	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 46.95	Generic · Prescription	DAR ALDAWA	Valid
CIPROFLACIN 500 MG FILM COATED TABLETS	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 21.05	Generic · Prescription	Ram Pharmaceutical Industries	Valid
CIPROGEN	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 54.25	Generic · Prescription	RIYADH PHARMA	Valid
CIPROGRAM 250 mg film-coated tablet	250 mg	Film-coated tablet · Oral use	10 Blister	SAR 30.65	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
CIPROGRAM 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 54.25	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
CIPROGRAM 750 mg film-coated tablet	750 mg	Film-coated tablet · Oral use	10 Blister	SAR 75.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
CIPROHEXAL 250MG F.C. TABLETS	250 mg	Film-coated tablet · Oral use	10 Blister	SAR 7.85	Generic · Prescription	HEXAL	Valid
CIPROHEXAL 500MG F.C. TABLETS	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 13.80	Generic · Prescription	HEXAL	Valid
CIPROLON 200 VIAL 100ML	200 mg	Solution for infusion · Parenteral use	1 Bottle	SAR 54.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CIPROMAX 500 MG TABLET	500 mg	Film-coated tablet · Oral use	10 Blister	SAR 62.05	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CIPROMAX 750MG TAB	750 mg	Film-coated tablet · Oral use	10 Blister	SAR 80.15	Generic · Prescription	SPIMACO ADDWAEIH	Valid

56 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PYELONEPHRITIS; ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - CAMPYLOBACTER INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - OTHER SALMONELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - SHIGELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - TYPHOID AND PARATYPHOID FEVERS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - VIBRIO CHOLERAE; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- ENTEROPATHOGENIC ESCHERICHIA COLI; BRUCELLOSIS; CROHN'S DISEASE; CYSTIC FIBROSIS; CYSTOISOSPORIASIS; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; LOWER URINARY TRACT INFECTIONS; ORCHITIS AND EPIDIDYMITIS; OSTEOMYELITIS; PERITONITIS; PREVENTION AND CHEMOPROPHYLAXIS OF BACTERIAL MENINGITIS- MENINGITIS, MENINGOCOCCAL INFECTIONS PREVENTION (CHEMOPROPHYLAXIS); Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); RENAL TRANSPLANT; TRAVEL RELATED INFECTIONS-TREATMENT; ULCERATIVE COLITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CIPRO	EQ 250MG BASE; EQ 500MG BASE	tablet · oral	BAYER HLTHCARE	Prescription	22 Oct 1987
CILOXAN	EQ 0.3% BASE	solution/drops · ophthalmic	SANDOZ	Prescription	31 Dec 1990
CIPRO	250MG/5ML; 500MG/5ML	for suspension · oral	BAYER HLTHCARE	Prescription	26 Sep 1997
CILOXAN	EQ 0.3% BASE	ointment · ophthalmic	SANDOZ	Prescription	30 Mar 1998
CIPRO XR	212.6MG; EQ 287.5MG BASE; 425.2MG; EQ 574.9MG BASE	tablet, extended release · oral	BAYER PHARMS	Prescription	28 Aug 2003
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	AIPING PHARM INC	Prescription	16 Mar 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE; EQ 250MG BASE; EQ 500MG BASE	tablet · oral	DR REDDYS LABS LTD	Prescription	9 Jun 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	tablet · oral	RISING	Prescription	9 Jun 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	solution/drops · ophthalmic	RUBICON RESEARCH	Prescription	9 Jun 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	IVAX SUB TEVA PHARMS	Prescription	9 Jun 2004
CIPROFLOXACIN	250MG	tablet · oral	CARLSBAD	Prescription	9 Jun 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	CARLSBAD	Prescription	9 Jun 2004
CIPROFLOXACIN	250MG	tablet · oral	HIKMA	Prescription	9 Jun 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	WATSON LABS	Prescription	9 Jun 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	UNIQUE	Prescription	10 Sep 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	CHARTWELL	Prescription	4 Nov 2004
CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	solution/drops · ophthalmic	WATSON LABS INC	Prescription	21 Jan 2005
CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	solution/drops · ophthalmic	RISING	Prescription	13 Dec 2006
CIPROFLOXACIN EXTENDED RELEASE	425.2MG;EQ 574.9MG BASE	tablet, extended release · oral	DR REDDYS LABS LTD	Prescription	26 Mar 2007
CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE	tablet · oral	AUROBINDO PHARMA	Prescription	26 Apr 2007
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML; 400MG/200ML	injectable · injection	HOSPIRA	Prescription	18 Mar 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML; 400MG/200ML	injectable · injection	INFORLIFE	Prescription	18 Mar 2008
CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	solution/drops · ophthalmic	FDC LTD	Prescription	30 Jun 2008
CETRAXAL	EQ 0.2% BASE	solution/drops · otic	LAB SALVAT	Prescription	1 May 2009
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	18 Nov 2009

41 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACT CIPROFLOXACIN	02247339	250 MG	TABLET · ORAL	TEVA CANADA LIMITED
ACT CIPROFLOXACIN	02247340	500 MG	TABLET · ORAL	TEVA CANADA LIMITED
ACT CIPROFLOXACIN	02247341	750 MG	TABLET · ORAL	TEVA CANADA LIMITED
AURO-CIPROFLOXACIN	02381907	250 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CIPROFLOXACIN	02381923	500 MG	TABLET · ORAL	AURO PHARMA INC
BIO-CIPROFLOXACIN	02444887	500 MG	TABLET · ORAL	BIOMED PHARMA
CILOXAN	01945270	0.3 % / W/V	SOLUTION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
CILOXAN	02200864	0.3 % / W/W	OINTMENT · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
CIPRO ORAL SUSPENSION	02237514	500 MG / 5 ML	SUSPENSION · ORAL	BAYER INC
CIPROFLOXACIN	02353318	250 MG	TABLET · ORAL	SANIS HEALTH INC
CIPROFLOXACIN	02353326	500 MG	TABLET · ORAL	SANIS HEALTH INC
CIPROFLOXACIN	02386119	250 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
CIPROFLOXACIN	02386127	500 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
CIPROFLOXACIN	02547147	500 MG	TABLET · ORAL	10445517 CANADA INC / NORTH PHARMACEUTICALS / DAC PHARMACEUTICALS
CIPROFLOXACIN INTRAVENOUS INFUSION BP	02304759	2 MG / ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
JAMP-CIPROFLOXACIN	02380358	250 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-CIPROFLOXACIN	02380366	500 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MAR-CIPROFLOXACIN	02379686	250 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-CIPROFLOXACIN	02379694	500 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MINT-CIPROFLOX	02423561	500 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
NRA-CIPROFLOXACIN	02492008	500 MG	TABLET · ORAL	NORA PHARMA INC
PMS-CIPROFLOXACIN	02248438	500 MG	TABLET · ORAL	PHARMASCIENCE INC
PRO-CIPROFLOXACIN	02317796	250 MG	TABLET · ORAL	PRO DOC LIMITEE
PRO-CIPROFLOXACIN	02317818	500 MG	TABLET · ORAL	PRO DOC LIMITEE
RIVA-CIPROFLOXACIN	02251248	500 MG	TABLET · ORAL	LABORATOIRE RIVA INC.

7 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CILOXAN 0.3% OINTMENT	$74.31212	per GM	23 Sep 2026
US NADAC	CIPRO 10% SUSPENSION	$1.45528	per ML	23 Sep 2026
US NADAC	CIPRO 5% SUSPENSION	$1.24862	per ML	23 Sep 2026
US NADAC	CIPROFLOXACIN 0.2% OTIC SOLN	$6.35188	per EA	23 Sep 2026
US NADAC	CIPROFLOXACIN 0.3% EYE DROP	$1.50392	per ML	23 Sep 2026
US NADAC	CIPROFLOXACIN 0.3% EYE DROP	$0.79641	per ML	23 Sep 2026
US NADAC	CIPROFLOXACIN 0.3% EYE DROP	$3.07806	per ML	23 Sep 2026
US NADAC	CIPROFLOXACIN HCL 250 MG TAB	$0.0751	per EA	23 Sep 2026
US NADAC	CIPROFLOXACIN HCL 500 MG TAB	$0.12284	per EA	23 Sep 2026
US NADAC	CIPROFLOXACIN HCL 750 MG TAB	$0.25021	per EA	23 Sep 2026
NHS Drug Tariff	Ciprofloxacin 0.3% eye drops	£4.70	5 ml	1 Oct 2026
NHS Drug Tariff	Ciprofloxacin 100mg tablets	£48.00	20 tablet	1 Oct 2026
NHS Drug Tariff	Ciprofloxacin 250mg tablets	£0.66	10 tablet	1 Oct 2026
NHS Drug Tariff	Ciprofloxacin 250mg/5ml oral suspension	£21.29	100 ml	1 Oct 2026
NHS Drug Tariff	Ciprofloxacin 2mg/ml ear drops 0.25ml unit dose preservative free	£6.01	15 unit dose	1 Oct 2026
NHS Drug Tariff	Ciprofloxacin 500mg tablets	£1.91	10 tablet	1 Oct 2026
NHS Drug Tariff	Ciprofloxacin 750mg tablets	£1.65	10 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

28. Ear, nose and throat medicines [c] · core
Infectious diseases of external ear
Local > Otological > drops: 0.3% (as hydrochloride) (EMLc)
6.2.2. Watch group antibiotics · core
First choice: Acute pyelonephritis (mild to moderate); First choice: Paratyphoid fever; First choice: Typhoid fever; First choice: Infectious gastroenteritis or colitis without specification of infectious agent; First choice: Neutropaenia (low-risk); First choice: Inflammatory or other diseases of prostate (mild to moderate); Second choice: Cholera; Second choice: Cholera [children]; Second choice: Peritoneal abscess (mild-moderate) (co-prescribed with metronidazole); Second choice: Peritonitis (mild-moderate) (co-prescribed with metronidazole)
Parenteral > General injections > IV: 2 mg per mL (as hyclate) (EMLc) | Oral > Liquid: 250 mg per 5 mL (anhydrous) (EMLc) | Oral > Solid > dosage form: 250 mg (as hydrochloride); 500 mg (as hydrochloride) (EML); 100 mg (as hydrochloride) (EMLc) | Oral > Solid > dosage form: 250 mg (as hydrochloride); 500 mg (as hydrochloride)

Safety signals and safety-related labeling changes

US FDA 20 Sep 2024 CIPRO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Sep 2024 CIPRO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Sep 2024 CIPRO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 3 Nov 2020 CIPRODEX — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 May 2020 CIPRO XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 May 2020 CIPRO XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Mar 2018 OTIPRIO — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Jul 2017 PRAC signal: Incompatibility leading to possible precipitation when co-administered intravenously
Action for MAH: update of the product information: Yes
US FDA 21 Mar 2017 CILOXAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 20 Mar 2017 CIPRO HC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations
EMA PRAC 9 Mar 2017 PRAC signal: Incompatibility leading to possible precipitation when co-administered intravenously
Action for MAH: update of the product information: No
EMA PRAC 1 Dec 2016 PRAC signal: Incompatibility leading to possible precipitation when co-administered intravenously
Action for MAH: update of the product information: No

All safety entries for ciprofloxacin →

Combinations containing Ciprofloxacin

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.