Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ciprofloxacin hydrochloride
Drug ID BADD_D00472
Description Ciprofloxacin is a second generation fluoroquinolone that has spawned many derivative antibiotics.[A178870] It is formulated for oral, intravenous, intratympanic, ophthalmic, and otic administration for a number of bacterial infections.[L6469,L6472,L6475,L6478,L6481,L6484,L6487,L6490,L6493] The first ciprofloxacin containing product was FDA approved on 22 October 1987.[L6463]
Indications and Usage Ciprofloxacin is only indicated in infections caused by susceptible bacteria.[L6469,L6472,L6475,L6478,L6481,L6484,L6487,L6490,L6493] Ciprofloxacin immediate release tablets, oral suspensions, and intravenous injections are indicated for the treatment of skin and skin structure infections, bone and joint infections, complicated intra-abdominal infections, nosocomial pneumonia, febrile neutropenia, adults who have inhaled anthrax, plague, chronic bacterial prostatitis, lower respiratory tract infections including acute exacerbations of chronic bronchitis, urinary tract infections, complicated urinary tract infections in pediatrics, complicated pyelonephritis in pediatrics, and acute sinusitis.[L6481,L6478] A ciprofloxacin otic solution and otic suspension with hydrocortisone are indicated for acute otitis externa.[L6469,L6484] Ciprofloxacin suspension with dexamethasone is indicated for acute otitis media in pediatric patients with tympanostomy tubes or acute otitis externa.[L6490] A ciprofloxacin intratympanic injection is indicated for pediatric patients with bilateral otitis media with effusion who are having tympanostomy tubes placed or pediatric patients 6 months or older with acute otitis externa.[L6493] A ciprofloxacin eye drop is indicated for bacterial corneal ulcers and conjunctivitis.[L6472] A ciprofloxacin eye ointment is indicated for bacterial conjunctivitis.[L6475] A ciprofloxacin extended release tablet is indicated for uncomplicated urinary tract infections, complicated urinary tract infections, and acute uncomplicated pyelonephritis.[L6487]
Marketing Status approved; investigational
ATC Code J01MA02; S03AA07; S02AA15; S01AE03
DrugBank ID DB00537
KEGG ID D02216
MeSH ID D002939
PubChem ID 62999
TTD Drug ID D0O1WX
NDC Product Code 62991-2518; 65862-379; 66021-0003; 71052-205; 71901-602; 17478-714; 45865-877; 53002-9320; 55700-884; 62135-310; 70934-965; 71335-2046; 72789-330; 12527-8512; 45865-721; 50090-1754; 51407-165; 61442-223; 62135-308; 68071-3351; 68788-8136; 71205-649; 71335-0836; 71335-1347; 72789-302; 65862-078; 50419-758; 68071-4139; 71205-536; 0404-7187; 71205-636; 72789-065; 82982-050; 12527-8513; 52286-0005; 52286-0015; 16571-120; 43063-923; 50090-5371; 50419-754; 51672-4086; 68071-2290; 70518-3714; 70934-093; 72162-1741; 51927-0236; 53104-7518; 16714-652; 51655-216; 62135-309; 63739-700; 65862-076; 68071-4576; 68084-070; 68999-309; 71610-159; 48589-0001; 58032-0006; 50090-5671; 59390-217; 61314-656; 63739-559; 68071-4235; 70518-1278; 71205-997; 71335-1024; 72189-111; 38779-0534; 53069-0180; 50090-2146; 62135-311; 68788-8198; 76420-045; 55111-010; 50090-3791; 51672-4085; 63187-150; 63629-8344; 65862-077; 68071-4627; 71610-109; 62704-0030; 0078-0841; 50090-5373; 51672-4087; 53002-1320; 63187-985; 63629-1010; 51943-112; 16714-651
UNII 4BA73M5E37
Synonyms Ciprofloxacin | Ciprofloxacin Hydrochloride Anhydrous | Anhydrous, Ciprofloxacin Hydrochloride | Hydrochloride Anhydrous, Ciprofloxacin | Cipro | Ciprofloxacin Hydrochloride | Hydrochloride, Ciprofloxacin | Ciprofloxacin Monohydrochloride Monohydrate | Monohydrate, Ciprofloxacin Monohydrochloride | Monohydrochloride Monohydrate, Ciprofloxacin | Bay-09867 | Bay 09867 | Bay09867 | Ciprinol
Chemical Information
Molecular Formula C17H19ClFN3O3
CAS Registry Number 86483-48-9
SMILES C1CC1N2C=C(C(=O)C3=CC(=C(C=C32)N4CCNCC4)F)C(=O)O.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pruritus23.03.12.001--
Pseudomembranous colitis07.19.01.003; 11.02.02.002--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Restlessness19.11.02.002; 17.02.05.021--
Rhinitis22.07.03.006; 11.01.13.004--
Seizure17.12.03.001--
Serum sickness-like reaction08.01.03.003; 10.01.03.005--Not Available
Skin hyperpigmentation23.05.01.003--
Skin irritation23.03.04.009--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Tachycardia02.03.02.007--Not Available
Tendon rupture15.07.01.008; 12.01.07.003--Not Available
Tendonitis12.01.07.007; 15.07.01.003--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Torsade de pointes02.03.04.005--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Urticaria10.01.06.001; 23.04.02.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Vasculitis24.12.04.027; 10.02.02.006--
Ventricular extrasystoles02.03.04.007--Not Available
Vision blurred06.02.06.007; 17.17.01.010--
Visual acuity reduced06.02.10.012; 17.17.01.011--
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