Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pentoxifylline
Drug ID BADD_D01731
Description Pentoxifylline (PTX) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and also has both anti-oxidant and anti-inflammatory properties.[A226415, L30300] Although originally developed to treat intermittent claudication, a form of exertion-induced leg pain common in patients with peripheral arterial disease, PTX has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis.[A226410, A226415, A226455] More recently, PTX has been suggested as a possible treatment for COVID-19-induced pulmonary complications due to its ability to regulate the production of inflammatory cytokines.[A226608] Pentoxifylline has been marketed in Europe since 1972; PTX extended-release tablets sold under the trade name TRENTAL by US Pharm Holdings were first approved by the FDA on Aug 30, 1984, but have since been discontinued. A branded product, PENTOXIL, marketed by Upsher-Smith Laboratories, and generic forms marketed by Valeant Pharmaceuticals and APOTEX have been available since the late 1990s.[L30300]
Indications and Usage Pentoxifylline is indicated for the treatment of intermittent claudication in patients with chronic occlusive arterial disease. Pentoxifylline may improve limb function and reduce symptoms but cannot replace other therapies such as surgical bypass or removal of vascular obstructions.[L30300]
Marketing Status approved; investigational
ATC Code C04AD03
DrugBank ID DB00806
KEGG ID D00501
MeSH ID D010431
PubChem ID 4740
TTD Drug ID D09QEI
NDC Product Code 62756-117; 66651-912; 60505-0033; 72643-032; 63629-2910; 12658-0515; 70518-1285; 12658-0503; 51552-1059; 51927-4389; 68682-101; 38779-2560; 49452-5080; 12658-0507; 61281-3500; 0615-8305; 60592-432; 62991-2521; 0904-5448; 12658-0434
UNII SD6QCT3TSU
Synonyms Pentoxifylline | Oxpentifylline | Trental | Pentoxil | Torental | Agapurin | BL-191 | BL 191 | BL191
Chemical Information
Molecular Formula C13H18N4O3
CAS Registry Number 6493-05-6
SMILES CC(=O)CCCCN1C(=O)C2=C(N=CN2C)N(C1=O)C
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)
Influenza like illness08.01.03.010--
Insomnia19.02.01.002; 17.15.03.0020.017188%
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Lacrimation increased06.08.02.004--
Laryngitis22.07.03.001; 11.01.13.001--
Leukaemia16.01.03.001; 01.10.03.001--
Leukopenia01.02.02.001--Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
Meningitis aseptic17.06.03.002; 11.01.03.002--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nasal congestion22.04.04.001--
Nausea07.01.07.0010.032814%
Nervousness19.06.02.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Palpitations02.11.04.012--
Pancytopenia01.03.03.003--Not Available
Penile pain21.12.01.0080.017188%
Pruritus23.03.12.001--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Rash23.03.13.001--Not Available
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
Shock24.06.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Swelling08.01.03.015--Not Available
Tachycardia02.03.02.007--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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