Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hydromorphone
Drug ID BADD_D01096
Description Hydromorphone is a pure opioid,[A176468] a semi-synthetic hydrogenated ketone derivative of [morphine] that has been available clinically since 1920. Structurally, hydromorphone derived from [morphine] in the modification of the hydroxyl group in the carbon 6 to a carbonyl and the absence of a double bond between the carbon 7 and 8. Due to these modifications, it presents a very high potency and comparable side effect profile to the parent compound.[A176471] Even though hydromorphone does not present a 6-hydroxyl group, it is categorized under the family of phenanthrenes and it is considered a chemical under the schedule II (medical purposes with high addiction potential).[A176495] The first reported approved product containing hydromorphone in the form of hydromorphone hydrochloride was developed by Fresenius Kabi USA and FDA approved in 1984.[L5795]
Indications and Usage Hydromorphone is indicated for the management of moderate to severe acute pain and severe chronic pain. Due to its addictive potential and overdose risk, hydromorphone is only prescribed when other first-line treatments have failed.[A176468] The WHO has proposed a three-step ladder for the management of pain in which it is suggested to start with a non-opioid medication followed by addition of weak opioids to the non-opioid treatment for moderate pain and finishing in the use of strong opioids such as hydromorphone along with the existing regimen for cases of severe pain.[A176471] Off-label, hydromorphone can be administered for the suppression of refractory cough.[A176468]
Marketing Status approved; illicit
ATC Code N02AA03
DrugBank ID DB00327
KEGG ID D08047
MeSH ID D004091
PubChem ID 5284570
TTD Drug ID D04JHN
NDC Product Code Not Available
UNII Q812464R06
Synonyms Hydromorphone | Dihydromorphinone | Hydromorphon | Palladone | Laudacon | Dilaudid | Hydromorphone Hydrochloride
Chemical Information
Molecular Formula C17H19NO3
CAS Registry Number 466-99-9
SMILES CN1CCC23C4C1CC5=C2C(=C(C=C5)O)OC3C(=O)CC4
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.004--Not Available
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal faeces07.01.03.001--Not Available
Accidental overdose12.09.03.001--Not Available
Acidosis14.01.03.0020.000185%
Addison's disease14.11.01.025; 10.04.08.008; 05.01.02.006--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alcohol abuse19.07.06.001--Not Available
Alcoholism19.07.06.006--Not Available
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Amblyopia06.02.01.0010.000185%Not Available
Amnesia19.20.01.001; 17.03.02.001--
Amylase increased13.05.01.009--
Anal fissure07.03.01.002--
Anaphylactic reaction24.06.03.006; 10.01.07.0010.001388%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anger19.04.02.001--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Ankylosing spondylitis15.01.09.001; 10.04.04.004--Not Available
Anxiety19.06.02.0020.005514%
Apathy19.04.04.002--Not Available
Aphasia19.21.01.001; 17.02.03.0010.000685%
Apnoea22.02.01.0010.000962%
Application site pain12.07.01.004; 08.02.01.004--Not Available
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