Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pyridostigmine
Drug ID BADD_D01881
Description Myasthenia gravis is an autoimmune disease involving dysfunction at the neuromuscular junction, most commonly due to autoantibodies directed against the acetylcholine receptor (AChR), which results in muscle tone loss, muscle weakness, and fatigue.[A231004] Acetylcholinesterase inhibitors have been the symptomatic treatment of choice in myasthenia gravis since the 1930s with the early use of [physostigmine] and [neostigmine]. By inhibiting the breakdown of acetylcholine in the neuromuscular junction, they increase signalling and relieve symptoms.[A231004, L32408, L32413] Pyridostigmine is the current drug of choice, with superior pharmacokinetics and reduced side effects compared to [neostigmine].[L32408, L32413] In addition to treating myasthenia gravis, pyridostigmine is used to reverse neuromuscular blocks, relieve symptoms in congenital myasthenic syndromes, and protect against certain nerve agents, notably during the Gulf War.[A231009, A231014, L32413, L32418] Pyridostigmine was granted initial FDA approval on April 6, 1955, as an oral tablet. Possible dose forms have been expanded to include extended-release tablets, syrups, and injections, marketed under various brand and generic names.[L32408, L32413]
Indications and Usage Pyridostigmine is indicated for the treatment of myasthenia gravis.[L32408] When administered intravenously, it is indicated for the reversal or antagonism of the neuromuscular blocking effects of nondepolarizing muscle relaxants.[L32413] Pyridostigmine has also been used as a prophylactic agent against irreversible organophosphorus acetylcholinesterase inhibitors, primarily in a military capacity.[L32418]
Marketing Status approved; investigational
ATC Code N07AA02
DrugBank ID DB00545
KEGG ID D00487
MeSH ID D011729
PubChem ID 4991
TTD Drug ID D0O2WB
NDC Product Code Not Available
UNII 19QM69HH21
Synonyms Pyridostigmine Bromide | Bromide, Pyridostigmine | Pyridostigmine | Mestinon
Chemical Information
Molecular Formula C9H13N2O2+
CAS Registry Number 155-97-5
SMILES C[N+]1=CC=CC(=C1)OC(=O)N(C)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)
Somnolence19.02.05.003; 17.02.04.006--
Sputum increased22.02.03.007--Not Available
Suicide attempt19.12.01.0040.003188%
Tachycardia02.03.02.0070.004250%Not Available
Tachypnoea22.02.01.0140.002125%Not Available
Thrombocytopenia01.08.01.0020.004250%Not Available
Thrombophlebitis24.01.02.001--Not Available
Toxic encephalopathy17.13.01.004; 12.03.01.0270.002125%Not Available
Tracheobronchitis22.07.01.016; 11.01.09.020--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.003188%
Urticaria23.04.02.001; 10.01.06.0010.002125%
Uterine haemorrhage24.07.03.004; 21.07.01.0050.008288%
Vertigo04.04.01.003; 17.02.12.0020.005738%
Vision blurred17.17.01.010; 06.02.06.0070.004675%
Vomiting07.01.07.0030.008500%
Ocular discomfort06.08.03.0080.003188%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Adverse event08.06.01.0100.003188%Not Available
Abnormal behaviour19.01.01.001--Not Available
Adverse drug reaction08.06.01.0090.007225%Not Available
Disease progression08.01.03.0380.002125%
Drug intolerance08.06.01.0130.008288%Not Available
Unevaluable event08.01.03.0510.002125%Not Available
Increased bronchial secretion22.12.01.002--Not Available
Treatment failure08.06.01.0170.002125%Not Available
Gastrointestinal sounds abnormal07.01.01.002--Not Available
Multiple organ dysfunction syndrome08.01.03.0570.002125%
Anal incontinence17.05.01.021; 07.01.06.029--
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