Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Epinephrine bitartrate
Drug ID BADD_D00783
Description Epinephrine, also known as _adrenaline_, is a hormone and neurotransmitter and produced by the adrenal glands that can also be used as a drug due to its various important functions. Though it has long been used in the treatment of hypersensitivity reactions, epinephrine in the auto-injector form (EpiPen) has been available since 1987 in the USA. Many new products/biosimilars and dosage routes have been approved under various names over the last several decades [L4355], [L4356], [L4358]. On August 16, 2018, Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths [L4353]. Dosage delivery routes for epinephrine include intravenous, inhalation, nebulization, intramuscular injection, and subcutaneous injection. In general, the most common uses of parenteral epinephrine are to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity (anaphylactic or anaphylactoid) reactions to drugs, animal serums and other allergens, and to prolong the action of infiltration anesthetics [F2136]. In addition to the above functions, epinephrine is the primary drug administered during cardiopulmonary resuscitation (CPR) to reverse cardiac arrest [A37697], [A37699]. It can be used in severe cases of croup [L4824].
Indications and Usage Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Injectable epinephrine is intended for immediate/urgent administration in patients, who are found to be at increased risk for anaphylaxis, including individuals with a history of anaphylaxis. Selection of the appropriate dosage strength is determined according to body weight [FDA label]. Epinephrine's cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes but is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock [F1247]. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine injection can be utilized to prolong the action of local anesthetics [F1247]. In addition to the above, epinephrine is used as an over the counter (OTC) agent for the intermittent symptoms of asthma, such as wheezing, tightness of chest and shortness of breath [F2131]. It is also used for the maintenance of mydriasis during intraocular surgery [L4825].
Marketing Status approved; vet_approved
ATC Code R01AA14; C01CA24; A01AD01; R03AA01; S01EA01; B02BC09
DrugBank ID DB00668
KEGG ID D02149
MeSH ID D004837
PubChem ID 5815
TTD Drug ID D04PHC
NDC Product Code 51927-0053; 54871-1096; 12828-0083; 49452-2750; 51552-0454; 54871-1097; 82245-0115; 65015-855; 51927-2395; 62991-2863; 65832-0005; 66064-1049
UNII 30Q7KI53AK
Synonyms Epinephrine | 4-(1-Hydroxy-2-(methylamino)ethyl)-1,2-benzenediol | Adrenaline | Epinephrine Acetate | Acetate, Epinephrine | Medihaler-Epi | Epinephrine Hydrochloride | Adrenaline Hydrochloride | Epitrate | Lyophrin | Epifrin | Epinephrine Bitartrate | Adrenaline Acid Tartrate | Epinephrine Hydrogen Tartrate | Adrenaline Bitartrate
Chemical Information
Molecular Formula C13H19NO9
CAS Registry Number 51-42-3
SMILES CNCC(C1=CC(=C(C=C1)O)O)O.C(C(C(=O)O)O)(C(=O)O)O
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)
Agitation19.06.02.001; 17.02.05.012--
Arrhythmia02.03.02.001--Not Available
Blood pressure increased13.14.03.005--Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Disorientation17.02.05.015; 19.13.01.002--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug interaction08.06.03.001--Not Available
Erythema23.03.06.001--Not Available
Extravasation08.01.03.008--Not Available
Feeling cold08.01.09.008--Not Available
Flushing23.06.05.003; 24.03.01.002; 08.01.03.025--
Gas gangrene23.11.02.010; 24.04.05.009; 11.02.02.008--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Haemoglobin13.01.05.018--Not Available
Hallucination19.10.04.003--
Hemiplegia17.01.04.002--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypokalaemia14.05.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Lactic acidosis14.01.01.002--Not Available
Local reaction08.01.03.012--Not Available
Memory impairment17.03.02.003; 19.20.01.003--
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myocardial infarction02.02.02.007; 24.04.04.009--
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