Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Protamine sulfate
Drug ID BADD_D01870
Description Since it's earliest discovery in salmon rine sperm heads in the late 1800's to its formal introduction via US FDA approval in 1939, protamine sulfate has occupied an important therapeutic niche as perhaps the only viable option for reversing the anticoagulant effect of heparin use for over 77 years [A174778, A174781]. Subsequently, because most invasive surgical procedures involve the routine use of heparin to prevent potentially surgery-complicating blood clotting, most cases of major bleeding in these frequent procedures are managed with the use of protamine sulfate [A174778]. The agent elicits this heparin reversal predominantly via the formation of an inactive complex between the anionic nature of heparin and its own cationic state [A174778, A174781, L5371]. Despite the relative importance of protamine sulfate's medical indication, the medication can notoriously cause a variety of potentially rare but genuinely severe adverse effects that include systemic hypotension, pulmonary hypertension, liver and kidney tissue damage, and anaphylactic reaction, amongst others [A174778, L5371]. As a consequence, whenever protamine sulfate use is clinically considered, careful consideration must be given as to whether the use of the agent could decrease the safety of the procedure or worsen the recovery of a patient after the procedure [A174778, A174781, L5371]. Regardless, protamine sulfate continues to see contemporary use given its genuine effectiveness in reversing heparin effects. Although current up to date reviews and studies continue to search for new therapeutic alternatives to protamine sulfate, most substitutes possess similar and unacceptable adverse effects [A174778, A174781]. Of the few agents that may be considered potentially successful alternatives - including idarucizumab for dabigatran reversal - their cost of procurement and potential range in reversing all parenteral anticoagulants are sometimes considered high and limited, respectively [A174778, A174781].
Indications and Usage Protamine sulfate is usually administered to reverse the large dose of heparin administered during certain surgeries, especially heart surgery.
Marketing Status Prescription; Discontinued
ATC Code V03AB14
DrugBank ID DB09141
KEGG ID D02224
MeSH ID D011479
PubChem ID Not Available
TTD Drug ID D03FXM
NDC Product Code 63323-229; 17353-0123; 72969-105; 51662-1414; 52221-110
Synonyms Protamines | Protamine | Protamine Sulfate | Sulfate, Protamine | Protamine Chloride | Chloride, Protamine
Chemical Information
Molecular Formula Not Available
CAS Registry Number 9009-65-8
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Back pain15.03.04.005--
Blood pressure decreased13.14.03.002--Not Available
Bradycardia02.03.02.002--Not Available
Capillary leak syndrome24.06.03.001; 08.01.07.012--
Cardiac output decreased13.14.02.001--Not Available
Circulatory collapse24.06.02.001--Not Available
Dyspnoea22.02.01.004; 02.01.03.002--
Fatigue08.01.01.002--
Feeling hot08.01.09.009--Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Nausea07.01.07.001--
Non-cardiogenic pulmonary oedema24.03.08.004; 22.01.03.006--Not Available
Pulmonary hypertension24.08.03.002; 22.06.01.001--
Respiratory distress22.02.01.012--Not Available
Vomiting07.01.07.003--
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