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)
Hypotonia15.05.04.008; 17.05.02.0020.002125%-
Hypoxia22.02.02.0030.002125%
Kaposi's sarcoma11.05.17.001; 16.33.02.0010.002125%-
Lacrimation increased06.08.02.004--
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.004--
Leukopenia01.02.02.0010.002125%-
Loss of consciousness17.02.04.004---
Metastatic malignant melanoma16.03.01.002; 23.08.01.0020.002125%-
Miosis06.05.03.003; 17.02.11.0020.002125%-
Muscle contractions involuntary15.05.03.008; 17.05.03.0010.002125%-
Muscle spasms15.05.03.0040.013600%
Muscle twitching15.05.03.0050.003188%-
Muscular weakness15.05.06.001; 17.05.03.0050.006800%
Myalgia15.05.02.001--
Myasthenia gravis10.04.05.001; 15.05.08.001; 17.05.04.0010.030813%
Nausea07.01.07.001--
Neck pain15.03.04.009--
Pallor08.01.03.032; 23.03.03.031; 24.03.04.001---
Paraesthesia17.02.06.005; 23.03.03.094--
Pollakiuria20.02.02.007--
Pulmonary oedema02.05.02.003; 22.01.03.003--
Rash23.03.13.001---
Respiratory depression17.02.05.047; 22.02.01.0100.002125%-
Respiratory distress22.02.01.0120.004250%-
Respiratory failure14.01.04.003; 22.02.06.0020.012750%
Respiratory paralysis17.01.04.010; 22.02.06.003---
Salivary hypersecretion07.06.01.0090.002125%-
Seizure17.12.03.001--
Sinoatrial block02.03.01.0100.002125%-
Sinus arrest02.03.03.0070.002125%-
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