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Psychedelic Safety Data

Term mapping

Trials report each adverse event as a term and file it under a MedDRA System Organ Class. This page puts those side by side so the harmonization is visible: how an effect is named, where it’s classified, and where the same term is filed under different organ systems across trials. Every term and grouping below is exactly as the trials reported it; we author none of it.

The organ-system groupings come with the registry data (no license needed). The full MedDRA dictionary of preferred terms requires a separate license.

1135 terms · 115 filed under >1 organ system
Reported termMedDRA System Organ ClassSeverityArms
Headache
Nervous system disordersGeneral disordersVascular disordersMusculoskeletal and connective tissue disordersinconsistent
Non-serious · Serious310
Nausea
Gastrointestinal disordersGeneral disordersMetabolism and nutrition disordersinconsistent
Non-serious · Serious264
Anxiety
Psychiatric disordersGeneral disordersNervous system disordersinconsistent
Non-serious · Serious253
Dizziness
Cardiac disordersNervous system disordersGeneral disordersEar and labyrinth disordersinconsistent
Non-serious · Serious245
Vomiting
Gastrointestinal disordersGeneral disordersinconsistent
Non-serious · Serious194
Fatigue
General disordersNervous system disordersPsychiatric disordersinconsistent
Non-serious · Serious193
Insomnia
Nervous system disordersPsychiatric disordersGeneral disordersinconsistent
Non-serious · Serious191
Suicidal ideation
Psychiatric disorders
Non-serious · Serious181
Dissociation
Psychiatric disorders
Non-serious143
Depression
Psychiatric disorders
Non-serious · Serious111
Vision blurred
Eye disorders
Non-serious109
Sedation
Nervous system disordersGeneral disordersPsychiatric disordersSurgical and medical proceduresinconsistent
Non-serious · Serious109
Hypoaesthesia
Nervous system disorders
Non-serious106
Somnolence
Psychiatric disordersNervous system disordersinconsistent
Non-serious104
Blood Pressure Increased
InvestigationsCardiac disordersinconsistent
Non-serious · Serious101
Dry mouth
Gastrointestinal disordersGeneral disordersinconsistent
Non-serious · Serious95
Paraesthesia
Nervous system disorders
Non-serious · Serious89
Suicide Attempt
Social circumstancesPsychiatric disordersinconsistent
Serious · Non-serious86
Dysgeusia
Gastrointestinal disordersNervous system disordersGeneral disordersinconsistent
Non-serious85
Vertigo
Ear and labyrinth disordersVascular disordersinconsistent
Non-serious · Serious82
Restlessness
General disordersNervous system disordersPsychiatric disordersinconsistent
Non-serious · Serious82
Back pain
Musculoskeletal and connective tissue disorders
Non-serious · Serious82
Irritability
General disordersNervous system disordersPsychiatric disordersSocial circumstancesinconsistent
Non-serious81
Hypoaesthesia Oral
Gastrointestinal disorders
Non-serious81
Palpitations
General disordersCardiac disordersinconsistent
Non-serious77
Diarrhoea
Gastrointestinal disorders
Non-serious · Serious77
Depressed mood
Psychiatric disordersNervous system disordersProduct issuesinconsistent
Non-serious75
Feeling abnormal
General disordersPsychiatric disordersinconsistent
Non-serious73
Upper respiratory tract infection
Infections and infestations
Non-serious71
Dizziness Postural
Nervous system disorders
Non-serious71
Constipation
Skin and subcutaneous tissue disordersGastrointestinal disordersinconsistent
Non-serious · Serious67
Asthenia
General disordersNervous system disordersPsychiatric disordersinconsistent
Non-serious · Serious66
Feeling Drunk
General disorders
Non-serious66
Visual impairment
Eye disorders
Non-serious65
Throat Irritation
Respiratory, thoracic and mediastinal disorders
Non-serious63
Euphoric mood
Psychiatric disorders
Non-serious61
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Non-serious60
Nasopharyngitis
Infections and infestations
Non-serious60
Hypertension
Vascular disordersCardiac disordersinconsistent
Non-serious58
Abdominal Pain
Gastrointestinal disordersPregnancy, puerperium and perinatal conditionsinconsistent
Non-serious · Serious58
Diarrhea
Gastrointestinal disordersGeneral disordersinconsistent
Non-serious · Serious56
Malaise
General disordersPsychiatric disordersinconsistent
Non-serious55
Decreased appetite
General disordersMetabolism and nutrition disordersGastrointestinal disordersinconsistent
Non-serious54
Tinnitus
Ear and labyrinth disordersNervous system disordersinconsistent
Non-serious54
Tremor
Musculoskeletal and connective tissue disordersNervous system disordersinconsistent
Non-serious53
Urinary tract infection
Infections and infestationsRenal and urinary disordersinconsistent
Non-serious · Serious52
Major Depression
Psychiatric disorders
Serious · Non-serious52
Paraesthesia Oral
Gastrointestinal disorders
Non-serious51
Confusional state
Nervous system disordersPsychiatric disordersinconsistent
Non-serious · Serious49
Diplopia
Eye disordersGeneral disordersNervous system disordersinconsistent
Non-serious49
Panic attack
Psychiatric disorders
Non-serious · Serious48
Hyperhidrosis
General disordersSkin and subcutaneous tissue disordersinconsistent
Non-serious47
Nasal Discomfort
Respiratory, thoracic and mediastinal disorders
Non-serious47
Abdominal Pain Upper
Gastrointestinal disorders
Non-serious44
Illusion
Psychiatric disorders
Non-serious44
Mental Impairment
Nervous system disorders
Non-serious43
Jaw clenching, tight jaw
General disorders
Non-serious42
Lack of appetite
General disorders
Non-serious42
Low mood
General disorders
Non-serious42
Muscle tightness
Musculoskeletal and connective tissue disorders
Non-serious42
Need more sleep
General disorders
Non-serious42
Pain
General disorders
Non-serious · Serious42
Influenza
Infections and infestationsGeneral disordersinconsistent
Non-serious41
Pyrexia
General disorders
Non-serious · Serious40
Completed Suicide
Psychiatric disorders
Serious40
Muscle Tension
General disordersMusculoskeletal and connective tissue disordersinconsistent
Non-serious39
Dyspnoea
Cardiac disordersRespiratory, thoracic and mediastinal disordersinconsistent
Non-serious · Serious38
Intentional self-injury
Psychiatric disorders
Non-serious · Serious38
Arthralgia
Musculoskeletal and connective tissue disorders
Non-serious · Serious38
Difficulty Concentrating
General disorders
Non-serious37
Myalgia
Musculoskeletal and connective tissue disorders
Non-serious37
Disturbance in attention
Nervous system disordersPsychiatric disordersinconsistent
Non-serious36
Nasal congestion
Respiratory, thoracic and mediastinal disordersGeneral disordersinconsistent
Non-serious36
Chest Pain
Cardiac disordersGeneral disordersinconsistent
Serious · Non-serious35
Weight Increased
Investigations
Non-serious35
Perspiration
General disordersSkin and subcutaneous tissue disordersinconsistent
Non-serious33
Drowsiness
General disordersNervous system disordersinconsistent
Non-serious33
Rash
Skin and subcutaneous tissue disorders
Serious · Non-serious33
Hallucination, Visual
Psychiatric disorders
Non-serious33
Thirst
General disorders
Non-serious31
Cough
Respiratory, thoracic and mediastinal disordersGeneral disordersReproductive system and breast disordersinconsistent
Non-serious31
Agitation
Psychiatric disordersSocial circumstancesinconsistent
Non-serious · Serious31
Migraine
Nervous system disorders
Non-serious · Serious31
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
Serious31
Muscle spasms
Musculoskeletal and connective tissue disorders
Non-serious30
Increased irritability
General disorders
Non-serious30
Dyspepsia
Gastrointestinal disorders
Non-serious29
Hyperacusis
Ear and labyrinth disorders
Non-serious29
Bruxism
Psychiatric disordersGeneral disordersinconsistent
Non-serious28
Muscular Weakness
Musculoskeletal and connective tissue disorders
Serious · Non-serious28
Slow speech
Nervous system disorders
Non-serious27
Blurred vision
Eye disordersNervous system disordersinconsistent
Serious · Non-serious27
Feeling Cold
General disorders
Non-serious27
Ankle Fracture
Injury, poisoning and procedural complications
Serious · Non-serious26
Hallucination
Psychiatric disorders
Non-serious25
Anger
Psychiatric disorders
Non-serious25
Bradycardia
Cardiac disorders
Non-serious · Serious25
Depersonalisation/Derealisation Disorder
Psychiatric disorders
Non-serious · Serious25
Dysarthria
Nervous system disorders
Non-serious · Serious24
Abdominal discomfort
Gastrointestinal disorders
Non-serious24
Time Perception Altered
Psychiatric disordersNervous system disordersinconsistent
Non-serious24
Vitreous floaters
Eye disorders
Non-serious24
Peripheral Coldness
Vascular disorders
Non-serious24
Neck pain
Musculoskeletal and connective tissue disorders
Non-serious23
Viral upper respiratory tract infection
Respiratory, thoracic and mediastinal disordersInfections and infestationsGeneral disordersinconsistent
Non-serious23
Contusion
Injury, poisoning and procedural complications
Non-serious · Serious23
Tachycardia
Cardiac disordersGeneral disordersinconsistent
Non-serious23
Oesophagitis
Gastrointestinal disorders
Serious23
General Physical Health Deterioration
General disorders
Serious23
Dissociative Disorder
Psychiatric disorders
Non-serious23
Tunnel Vision
Nervous system disorders
Non-serious23
Nasal Pruritus
Respiratory, thoracic and mediastinal disorders
Non-serious23
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
Non-serious23
Depersonalisation
Psychiatric disorders
Non-serious23
Sinus Bradycardia
Cardiac disorders
Non-serious23
Ear Congestion
Ear and labyrinth disorders
Non-serious23
Accommodation Disorder
Eye disorders
Non-serious23
Conjunctival Hyperaemia
Eye disorders
Non-serious23
Nystagmus
General disordersNervous system disordersinconsistent
Non-serious22
Road traffic accident
Injury, poisoning and procedural complications
Non-serious · Serious22

On MedDRA’s fit for psychedelic effects

Some experiences central to psychedelic trials don’t map cleanly to MedDRA’s terms, so they can be filed under generic categories or go unrecorded. Work on a psychedelic-specific adverse-event vocabulary has been proposed to address this. This paragraph is our own observation. The terms in the table above are exactly as each trial reported and classified them; we add no mappings of our own.

A project by Tyler Hathaway

Not a regulatory or clinical tool, and no medical advice. Not affiliated with any sponsor, regulator, or any organization whose trials appear here.