Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Phenazopyridine hydrochloride
Drug ID BADD_D01746
Description Phenazopyridine, also known as Pyridium, is a urinary tract analgesic used for the short-term management of urinary tract irritation and its associated unpleasant symptoms such as burning and pain during urination. In the USA, this drug was previously marked by Roche but has been discontinued by the FDA.[L7832] It is still used in various parts of the world. Ingestion of phenazopyridine is found to change the appearance of the urine by imparting an orange or red color, as it is considered an azo dye.[L7829]
Indications and Usage Phenazopyridine hydrochloride is indicated to relieve uncomfortable symptoms that occur as a consequence of mucosal irritation of the lower urinary tract in adults. The irritation may be a result of trauma, surgery, endoscopic procedures, infection, or the insertion of instruments or urinary catheters.[L7826] Phenazopyridine may be used in combination with antimicrobial therapy but is not used as an antimicrobial agent. It contributes to the relief of discomfort and pain before antimicrobial therapy begins to take effect. It is important to note that the duration of treatment with this drug should last a maximum of 2 days.[L7826] Phenazopyridine is available in many countries as an over the counter drug.[A182147]
Marketing Status approved
ATC Code G04BX06
DrugBank ID DB01438
KEGG ID D05450
MeSH ID D010621
PubChem ID 8691
TTD Drug ID D00VUL
NDC Product Code 63189-011; 63189-012; 30142-221; 53002-3150; 62011-0325; 62135-403; 68071-2273; 71205-495; 71335-2140; 10956-001; 50090-6207; 55910-631; 63629-1145; 63868-117; 67296-1242; 68788-7778; 69842-713; 70000-0523; 70518-2169; 70518-2330; 71335-0898; 72476-210; 81860-113; 62485-032; 50090-3519; 53002-3151; 68071-5274; 55700-898; 68016-129; 68071-5180; 71205-998; 73581-909; 75826-114; 63189-013; 10956-210; 46122-337; 49035-297; 55319-211; 62135-404; 0363-7775; 69256-767; 70677-0078; 71205-999; 71335-1661; 72789-148; 75826-115; 21130-792; 30142-564; 30142-756; 30142-757; 42192-801; 50090-6559; 51655-398; 51655-512; 61919-678; 63029-105; 0363-7776; 68071-2212; 70000-0241; 70518-2170; 71205-836; 80584-113; 10267-0317; 62705-0122; 50090-5520; 50090-6554; 58657-450; 70795-1252; 73712-113; 49452-5166; 50696-001; 36800-510; 46122-628; 53002-4630; 58657-451; 62011-0412; 63868-297; 67296-1233; 69367-162; 69367-191; 70518-3226; 71205-163; 71205-835; 71335-2183; 10956-551; 10956-703; 36800-040; 49348-076; 61919-216; 63629-1146; 0363-8455; 69367-163; 70000-0243; 70795-1241; 71205-584; 71335-2139; 73028-201; 11822-3111; 11822-8855; 41250-342; 42192-802; 49973-247; 67296-1350; 69367-192; 71309-779; 71335-2184; 73028-202; 62485-031; 63189-008; 11673-270; 37012-098; 50090-3520; 53002-3152; 53943-336
UNII 0EWG668W17
Synonyms Phenazopyridine | Azo-Gesic | Azo Gesic | AzoGesic | Azo-Natural | Azo Natural | AzoNatural | Azo-Standard | Azo Standard | AzoStandard | Baridium | UTI Relief | Phenazo | Phenazopyridine Hydrochloride | Hydrochloride, Phenazopyridine | Prodium | Pyridium | Re-Azo | Re Azo | ReAzo | Urogesic | Azo-Dine | Azo Dine | AzoDine | Geridium | Pyridiate
Chemical Information
Molecular Formula C11H11N5.ClH
CAS Registry Number 136-40-3
SMILES C1=CC=C(C=C1)N=NC2=C(N=C(C=C2)N)N.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)
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Diarrhoea07.02.01.001--
Gastrointestinal disorder07.11.01.001---
Glucose-6-phosphate dehydrogenase deficiency01.06.05.001; 03.08.03.001; 14.14.03.001---
Haemolytic anaemia01.06.03.002---
Headache17.14.01.001--
Hepatitis09.01.07.004---
Hepatotoxicity09.01.07.009; 12.03.01.008---
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Meningitis aseptic11.01.03.002; 17.06.03.002---
Methaemoglobinaemia01.05.01.002--
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Nephropathy toxic12.03.01.010; 20.05.03.002---
Pruritus23.03.12.001--
Rash23.03.13.001---
Sulphaemoglobinaemia01.05.01.003---
Tongue discolouration07.14.02.006---
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Product contamination with body fluid27.02.01.001---
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