Reported Reactions

Adverse event reports that FDA received

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Reaction terms

A reaction term is a MedDRA preferred term. The person who codes a report selects the term that agrees best with the description of the reporter. A term has a page when 5,000 or more reports record it. Search engines may index the pages of the terms with 20,000 reports or more. A term is not a finding about a product.

1,436 reaction terms in order of name, with the plain meaning that this site gives
Reaction term (MedDRA)Plain meaning
Abasia
Abdominal discomfortstomach discomfort
Abdominal distensiona bloated abdomen
Abdominal painstomach or belly pain
Abdominal pain lower
Abdominal pain upperupper stomach pain
Abnormal behaviourunusual behaviour
Abnormal dreamsunusual dreams
Abnormal faeces
Abnormal loss of weight
Abnormal weight gain
Abortion induced
Abortion spontaneousmiscarriage
Abscessa collection of pus
Accident
Accidental exposure to product
Accidental exposure to product by child
Accidental overdosean accidental overdose
Accidental underdose
Acidosis
Acneacne
Activities of daily living impaired
Acute coronary syndrome
Acute generalised exanthematous pustulosis
Acute hepatic failure
Acute kidney injurysudden loss of kidney function
Acute myeloid leukaemia
Acute myocardial infarction
Acute pulmonary oedema
Acute respiratory distress syndrome
Acute respiratory failure
Adrenal insufficiencythe adrenal glands produce too little hormone
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)
Adverse eventan unwanted medical event, type not specified
Adverse reaction
Affect lability
Affective disorder
Ageusialoss of taste
Aggressionaggressive behaviour
Agitationrestlessness
Agranulocytosis
Akathisiainner restlessness and an urge to move
Alanine aminotransferase increasedraised liver enzyme (ALT)
Alopeciahair loss
Altered state of consciousness
Amenorrhoeaperiods stopped
Amnesiamemory loss
Anaemialow red blood cells
Anal abscess
Anal fissure
Anal fistula
Anal incontinence
Anaphylactic reactiona severe, sudden allergic reaction
Anaphylactic shocka severe allergic reaction with collapse
Anger
Angina pectoris
Angina unstable
Angioedemadeep swelling of skin or mucous membranes
Angiopathy
Anhedonia
Ankle fracture
Ankylosing spondylitis
Anorectal discomfort
Anorexia
Anosmialoss of smell
Anti-cyclic citrullinated peptide antibody positive
Anuria
Anxietyanxiety
Aortic aneurysma bulge in the main artery
Apathy
Aphasiadifficulty with language
Aphonia
Aphthous ulcer
Aplastic anaemia
Apnoeapauses in breathing
Appendicitis
Appetite disorder
Application site erythemaredness where the product was applied
Application site irritation
Application site pain
Application site pruritusitching where the product was applied
Application site rash
Application site reactiona reaction where the product was applied
Application site vesicles
Arrhythmia
Arterial occlusive disease
Arteriosclerosis
Arteriosclerosis coronary artery
Arthralgiajoint pain
Arthritis
Arthropathy
Arthropod bite
Ascitesfluid in the abdomen
Aspartate aminotransferase increasedraised liver enzyme (AST)
Aspergillus infection
Asphyxia
Aspirationbreathing material into the lungs
Astheniaweakness or lack of energy
Asthenopia
Asthmaasthma
Ataxia
Atelectasis
Atrial fibrillationan irregular heart rhythm
Atrial flutter
Atrial septal defect
Atrioventricular block
Atrioventricular block complete
Autism spectrum disorder
Autoimmune disorder
Autoimmune hepatitis
Back disorder
Back injury
Back painback pain
Bacteraemia
Bacterial infectiona bacterial infection
Balance disorderproblems with balance
Basal cell carcinoma
Bedridden
Behaviour disorder
Benign prostatic hyperplasia
Bipolar disorderbipolar disorder
Bladder cancer
Bladder disorder
Blepharospasm
Blindnessloss of sight
Blindness transient
Blindness unilateral
Blistera blister
Blood albumin decreased
Blood alkaline phosphatase increased
Blood bilirubin increased
Blood calcium decreased
Blood calcium increased
Blood cholesterol increasedraised cholesterol
Blood count abnormal
Blood creatine phosphokinase increased
Blood creatinine increasedraised creatinine, a kidney test
Blood disorder
Blood glucose abnormal
Blood glucose decreasedlow blood sugar reading
Blood glucose fluctuation
Blood glucose increasedraised blood sugar reading
Blood iron decreased
Blood lactate dehydrogenase increased
Blood lactic acid increased
Blood magnesium decreased
Blood potassium decreased
Blood potassium increased
Blood pressure abnormal
Blood pressure decreaseda low blood pressure reading
Blood pressure diastolic decreased
Blood pressure fluctuation
Blood pressure inadequately controlled
Blood pressure increaseda raised blood pressure reading
Blood pressure systolic increased
Blood sodium decreased
Blood test abnormal
Blood testosterone decreased
Blood thyroid stimulating hormone increased
Blood triglycerides increased
Blood urea increased
Blood uric acid increasedraised uric acid
Blood urine present
Body height decreased
Body temperature decreased
Body temperature increasedraised temperature
Bone density decreased
Bone disorder
Bone loss
Bone marrow failure
Bone painbone pain
Bowel movement irregularity
Bradycardiaslow heart rate
Bradykinesia
Bradyphrenia
Brain fog
Brain injury
Brain neoplasm
Brain oedema
Breast cancerbreast cancer
Breast cancer female
Breast cancer metastatic
Breast cancer stage I
Breast cancer stage II
Breast cancer stage III
Breast mass
Breast painbreast pain
Breast tenderness
Bronchiectasis
Bronchitischest infection
Bronchopulmonary aspergillosis
Bronchospasmtightening of the airways
Bruxism
Burning sensationa burning feeling
Bursitis
C-reactive protein abnormal
C-reactive protein increased
Cachexia
Caesarean section
Candida infectionthrush, a yeast infection
Cardiac arrestthe heart stopped
Cardiac disorder
Cardiac failureheart failure
Cardiac failure acute
Cardiac failure congestivecongestive heart failure
Cardiac flutter
Cardiac murmur
Cardiac operation
Cardiac pacemaker insertion
Cardiac valve disease
Cardio-respiratory arrestthe heart and breathing stopped
Cardiogenic shockshock from the heart failing to pump
Cardiomegaly
Cardiomyopathydisease of the heart muscle
Cardiotoxicity
Cardiovascular disorder
Carpal tunnel syndrome
Cataractclouding of the eye lens
Cataract operation
Catatonia
Cellulitisa skin infection
Central nervous system lesion
Cerebral disorder
Cerebral haemorrhage
Cerebral infarction
Cerebral ischaemia
Cerebrovascular accidentstroke
Cheilitis
Chest discomfortchest discomfort
Chest painchest pain
Chillschills or shivering
Chokingchoking
Choking sensation
Cholangitis
Cholecystectomy
Cholecystitisinflamed gallbladder
Cholecystitis acute
Cholecystitis chronic
Cholelithiasisgallstones
Cholestasis
Chromaturia
Chronic kidney diseaselong-term kidney disease
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease
Circulatory collapsecollapse of the circulation
Circumstance or information capable of leading to medication errora situation that could lead to a medication error
Clostridium difficile colitisa bowel infection with C. difficile
Clostridium difficile infection
Coagulopathy
Coeliac disease
Cognitive disorderproblems with thinking or memory
Cold sweat
Colectomy
Colitisinflamed bowel
Colitis ischaemic
Colitis ulcerative
Colon cancer
Colorectal cancer
Colorectal cancer stage III
Coma
Completed suicidedeath by suicide
Complication associated with device
Complication of device insertion
Complication of device removal
Compression fracture
Concomitant disease aggravated
Concussionconcussion
Condition aggravatedthe condition being treated got worse
Confusional stateconfusion
Congenital anomalya condition present at birth
Conjunctivitispink eye
Constipationconstipation
Contraindicated product administered
Contusiona bruise
Convulsion
Coordination abnormal
Coronary artery bypass
Coronary artery disease
Coronary artery occlusion
Coronavirus infection
Coughcough
Covid-19COVID-19 infection
COVID-19 pneumonia
Crohn's disease
Crohn's diseaseCrohn's disease, an inflammatory bowel disease
Cryingcrying
Cyanosis
Cyst
Cystic fibrosis
Cystitis
Cytokine release syndrome
Cytomegalovirus infection
Cytopenia
Deafnesshearing loss
Deafness unilateral
Deaththe patient died; cause not stated by this term
Decreased activityless active than usual
Decreased appetitereduced appetite
Decreased immune responsiveness
Decreased interest
Decubitus ulcera pressure sore
Deep vein thrombosisa blood clot in a deep vein
Defaecation urgency
Deformity
Dehydrationdehydration
Deliriumsudden confusion
Delusiona fixed false belief
Dementiadementia
Dementia Alzheimer's type
Dental caries
Dependence
Depressed level of consciousness
Depressed moodlow mood
Depressionlow mood
Dermatitisinflamed skin
Dermatitis acneiform
Dermatitis allergic
Dermatitis atopic
Dermatitis bullous
Dermatitis contact
Developmental delayslower development in a child
Device adhesion issue
Device breakagethe device broke
Device defective
Device delivery system issuea problem with the delivery system
Device deployment issuethe device did not deploy properly
Device difficult to usethe device was hard to use
Device dislocationthe device moved out of position
Device expulsionthe device came out
Device failurethe device failed
Device information output issue
Device issuea problem with the device
Device leakagethe device leaked
Device malfunctionthe device did not work properly
Device mechanical issue
Device occlusionthe device blocked
Device physical property issuea physical problem with the device
Device related infectionan infection related to the device
Device use errora mistake in using the device
Device use issue
Diabetes mellitusdiabetes
Diabetes mellitus inadequate controldiabetes not well controlled
Diabetic ketoacidosisa serious complication of diabetes with acid build-up
Dialysisdialysis
Diarrhoealoose or frequent stools
Diarrhoea haemorrhagic
Diffuse large B-cell lymphoma
Diplopiadouble vision
Disability
Discomfortdiscomfort
Disease progressionthe disease advanced
Disease recurrencethe disease came back
Disorientation
Disseminated intravascular coagulation
Dissociation
Disturbance in attentiondifficulty concentrating
Diverticulitis
Diverticulum
Dizzinesslight-headedness or unsteadiness
Dizziness postural
Drooling
Drug abusemisuse of a medicine
Drug abuser
Drug administered at inappropriate site
Drug administered to patient of inappropriate age
Drug administration errora mistake in giving the medicine
Drug dependencedependence on a medicine
Drug dispensing errora dispensing mistake
Drug diversion
Drug dose omissiona dose was missed
Drug dose omission by device
Drug effect decreasedthe medicine had less effect
Drug effect incomplete
Drug effect less than expected
Drug effective for unapproved indication
Drug eruption
Drug exposure during pregnancythe medicine was taken during pregnancy
Drug hypersensitivityan allergic-type reaction (the term names a medicine)
Drug ineffectivethe medicine did not work as expected
Drug ineffective for unapproved indication
Drug interactionan interaction between medicines
Drug intolerancethe medicine was not tolerated
Drug level below therapeutic
Drug level decreaseda low blood level of the medicine
Drug level increaseda raised blood level of the medicine
Drug prescribing errora prescribing mistake
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement
Drug resistance
Drug screen positive
Drug specific antibody present
Drug toxicity
Drug use disorder
Drug withdrawal syndromesymptoms on stopping a medicine
Drug withdrawal syndrome neonatal
Drug-induced liver injury
Dry eyedry eye
Dry mouthdry mouth
Dry skindry skin
Dry throat
Duodenal ulcer
Duodenal ulcer perforation
Dysarthria
Dysgeusiaaltered taste
Dysgraphia
Dyskinesiainvoluntary movements
Dyslipidaemia
Dysmenorrhoea
Dyspepsiaindigestion
Dysphagiadifficulty swallowing
Dysphoniaa hoarse voice
Dysphoria
Dyspnoeashortness of breath
Dyspnoea exertional
Dysstasia
Dystoniainvoluntary muscle contractions
Dysuriapain on passing urine
Ear discomfort
Ear infectionan ear infection
Ear painearache
Eating disorder
Ecchymosis
Economic problema financial problem
Eczemaeczema
Ejection fraction decreased
Electrocardiogram abnormal
Electrocardiogram QRS complex prolonged
Electrocardiogram QT prolongeda QT prolongation on the ECG
Electrolyte imbalance
Embedded device
Embolism
Emotional disorder
Emotional distressemotional distress
Emphysema
Encephalitis
Encephalopathy
End stage renal diseasekidney failure needing dialysis or transplant
Endocarditis
Endophthalmitisinfection inside the eye
Energy increased
Enteritis
Enterocolitis
Eosinophil count increased
Eosinophilia
Epilepsy
Epistaxisnosebleed
Epstein-Barr virus infection
Erectile dysfunctiondifficulty getting or keeping an erection
Eructation
Erythemaskin redness
Erythema multiformea skin reaction with target-shaped patches
Erythema of eyelid
Escherichia infection
Euphoric mood
Exercise tolerance decreased
Exostosis
Expired product administeredthe product was used past its expiry date
Exposure during pregnancythe medicine was taken during pregnancy
Exposure via skin contact
Extra dose administered
Extrapyramidal disordermovement problems such as stiffness or tremor
Extrasystoles
Eye discharge
Eye disorder
Eye haemorrhage
Eye infection
Eye inflammation
Eye irritationeye irritation
Eye movement disorder
Eye paineye pain
Eye pruritus
Eye swellinga swollen eye
Eyelid oedemaa swollen eyelid
Eyelid ptosis
Face oedemaswelling of the face
Facial pain
Facial paralysis
Faecaloma
Faeces discoloured
Faeces soft
Failure to thrivepoor growth in a child
Falla fall
Fatiguetiredness
Fear
Fear of injection
Febrile neutropeniafever with low white blood cells
Feeding disordera feeding problem
Feeling abnormalfeeling odd or not right
Feeling coldfeeling cold
Feeling drunk
Feeling hotfeeling hot
Feeling jittery
Feeling of body temperature change
Femoral neck fracture
Femur fracture
Fibromyalgia
Fistula
Flank pain
Flatulencewind
Fluid overload
Fluid retentionthe body holding extra fluid
Flushingsudden reddening or warmth of the skin
Foetal death
Foetal exposure during pregnancythe unborn baby was exposed to the medicine
Foetal growth restriction
Folliculitis
Food allergy
Food poisoning
Foot deformity
Foot fracture
Foreign body in reproductive tract
Foreign body sensation in eyes
Formication
Fracturea broken bone
Frequent bowel movements
Frustration tolerance decreased
Full blood count abnormal
Full blood count decreased
Fungal infectiona fungal infection
Furuncle
Gait disturbancedifficulty walking
Gait inability
Galactorrhoea
Gallbladder disorder
Gamma-glutamyltransferase increased
Gangrenedeath of tissue
Gastric cancer
Gastric disorder
Gastric haemorrhage
Gastric ulcera stomach ulcer
Gastric ulcer haemorrhage
Gastritisinflamed stomach lining
Gastroenteritisstomach bug
Gastroenteritis viral
Gastrointestinal carcinoma
Gastrointestinal disorder
Gastrointestinal haemorrhagebleeding in the stomach or bowel
Gastrointestinal infection
Gastrointestinal inflammation
Gastrointestinal motility disorder
Gastrointestinal pain
Gastrooesophageal reflux diseaseacid reflux
General physical condition abnormal
General physical health deteriorationgeneral decline in health
General symptom
Generalised erythema
Generalised oedema
Generalised tonic-clonic seizure
Genital haemorrhage
Gingival bleedingbleeding gums
Gingival pain
Gingivitis
Glaucomaraised pressure in the eye
Glomerular filtration rate decreasedreduced kidney filtering
Glossodynia
Glucose tolerance impaired
Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure
Goutgout
Graft versus host disease
Grand mal convulsion
Granulocytopenia
Grip strength decreased
Groin pain
Gynaecomastiabreast enlargement in men
Haemarthrosis
Haematemesis
Haematocheziablood in the stool
Haematocrit decreased
Haematomaa collection of blood under the skin or in tissue
Haematotoxicity
Haematuriablood in the urine
Haemodialysis
Haemodynamic instability
Haemoglobin abnormal
Haemoglobin decreasedlow haemoglobin
Haemolysis
Haemolytic anaemia
Haemophagocytic lymphohistiocytosis
Haemoptysiscoughing up blood
Haemorrhagebleeding
Haemorrhage intracranial
Haemorrhagic stroke
Haemorrhoids
Hair colour changes
Hair disorder
Hair growth abnormal
Hair texture abnormal
Hallucinationseeing or hearing things that are not there
Hallucination, auditory
Hallucination, visual
Hand deformity
Hand fracture
Head discomfortdiscomfort in the head
Head injurya head injury
Headachehead pain
Hearing impairedreduced hearing
Heart rate abnormal
Heart rate decreased
Heart rate increaseda fast heart rate reading
Heart rate irregular
Heavy menstrual bleeding
Helicobacter infection
Hemiparesis
Hemiplegia
Hepatic cancer
Hepatic cirrhosis
Hepatic cytolysis
Hepatic encephalopathy
Hepatic enzyme increasedraised liver enzymes
Hepatic failureliver failure
Hepatic function abnormal
Hepatic steatosisfatty liver
Hepatitis
Hepatitis acute
Hepatitis Bhepatitis B infection
Hepatitis Chepatitis C infection
Hepatitis cholestatic
Hepatocellular carcinoma
Hepatocellular injury
Hepatomegaly
Hepatotoxicityliver injury
Hereditary angioedema
Hernia
Herpes simplexa cold sore or genital herpes
Herpes virus infection
Herpes zostershingles
Hiatus hernia
Hiccups
Hidradenitis
Hip arthroplasty
Hip fracturea broken hip
Hip surgery
Hospice care
Hospitalisationadmission to hospital
Hot flusha hot flush
Hunger
Hydrocephalus
Hydronephrosis
Hyperaesthesia
Hyperbilirubinaemia
Hypercalcaemiahigh blood calcium
Hyperchlorhydria
Hypercholesterolaemia
Hyperglycaemiahigh blood sugar
Hyperhidrosisexcessive sweating
Hyperkalaemiahigh blood potassium
Hyperkeratosis
Hyperlipidaemiaraised blood fats
Hyperprolactinaemia
Hypersensitivityan allergic-type reaction
Hypersomniasleeping too much
Hypertensionhigh blood pressure
Hypertensive crisis
Hyperthermia
Hyperthyroidismoveractive thyroid
Hypertonia
Hypertransaminasaemia
Hypertriglyceridaemia
Hyperventilation
Hypoacusisreduced hearing
Hypoaesthesianumbness
Hypoaesthesia oral
Hypoalbuminaemia
Hypocalcaemialow blood calcium
Hypogammaglobulinaemia
Hypoglycaemialow blood sugar
Hypokalaemialow blood potassium
Hypokinesia
Hypomagnesaemialow blood magnesium
Hyponatraemialow blood sodium
Hypophagia
Hypophosphataemia
Hypotensionlow blood pressure
Hypothermia
Hypothyroidismunderactive thyroid
Hypotonia
Hypovolaemia
Hypoxialow oxygen
Hysterectomy
Ileusthe bowel stopped moving
Ill-defined disordera condition that was not clearly described
Illness
Immune effector cell-associated neurotoxicity syndrome
Immune system disorder
Immunodeficiency
Immunosuppressionreduced immune defences
Impaired driving ability
Impaired gastric emptying
Impaired healingslow healing
Impaired quality of life
Impaired work abilityreduced ability to work
Inability to afford medication
Inadequate analgesia
Inappropriate antidiuretic hormone secretion
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times
Inappropriate schedule of product administrationthe product was taken at the wrong times
Incoherent
Incontinence
Incorrect dose administeredthe wrong dose was given
Incorrect dose administered by devicethe device gave the wrong dose
Incorrect drug administration duration
Incorrect product administration duration
Incorrect product storagethe product was stored wrongly
Incorrect route of drug administrationthe medicine was given by the wrong route
Incorrect route of product administrationthe product was given by the wrong route
Increased appetite
Increased tendency to bruise
Increased upper airway secretion
Infarction
Infectionan infection, type not specified
Infective pulmonary exacerbation of cystic fibrosis
Inflammationinflammation
Inflammatory bowel disease
Influenzaflu
Influenza like illnessflu-like symptoms
Infusion related reactiona reaction during or soon after an infusion
Infusion site erythema
Infusion site extravasationinfusion fluid leaked into surrounding tissue
Infusion site pain
Infusion site swelling
Inguinal hernia
Initial insomnia
Injection site bruisingbruising where the injection was given
Injection site discharge
Injection site discolouration
Injection site discomfort
Injection site erythemaredness where the injection was given
Injection site extravasation
Injection site haematoma
Injection site haemorrhagebleeding where the injection was given
Injection site induration
Injection site injury
Injection site irritation
Injection site mass
Injection site nodule
Injection site painpain where the injection was given
Injection site pruritusitching where the injection was given
Injection site rash
Injection site reactiona reaction where the injection was given
Injection site swellingswelling where the injection was given
Injection site urticaria
Injection site vesicles
Injection site warmth
Injurya physical injury
Injury associated with device
Insomniadifficulty sleeping
Insurance issue
Intentional dose omission
Intentional drug misuse
Intentional overdosea deliberate overdose
Intentional product misusedeliberate use not as intended
Intentional product use issuedeliberate use not as intended
Intentional self-injury
Intentional underdose
Intercepted product administration error
Intercepted product preparation error
Intermenstrual bleeding
Internal haemorrhage
International normalised ratio increasedblood clotting slower than intended (raised INR)
Interstitial lung diseasescarring or inflammation of lung tissue
Intervertebral disc degeneration
Intervertebral disc protrusiona bulging spinal disc
Intestinal haemorrhage
Intestinal ischaemia
Intestinal obstructiona blocked bowel
Intestinal perforation
Intestinal resection
Intra-uterine contraceptive device expelled
Intracranial pressure increased
Intraocular pressure increasedraised pressure in the eye
Iron deficiency anaemiaanaemia from low iron
Irritabilityirritability
Irritable bowel syndrome
Ischaemic stroke
Jaundiceyellowing of the skin or eyes
Jaw disorder
Joint dislocationa dislocated joint
Joint effusion
Joint injury
Joint range of motion decreasedreduced movement of a joint
Joint stiffnessa stiff joint
Joint swellinga swollen joint
Ketoacidosis
Kidney infection
Knee arthroplasty
Knee operation
Labelled drug-drug interaction medication error
Laboratory test abnormal
Lacerationa cut
Lacrimation increasedwatery eyes
Lactic acidosisa build-up of lactic acid in the blood
Large intestine perforation
Large intestine polyp
Laryngeal oedemaswelling of the voice box
Laryngitis
Learning disability
Left ventricular dysfunction
Lethargysluggishness
Leukaemia
Leukocytosis
Leukopenialow white blood cells
Libido decreasedreduced sex drive
Ligament sprain
Limb discomfortdiscomfort in an arm or leg
Limb injury
Lip dry
Lip swellingswollen lips
Lipase increased
Liquid product physical issue
Live birth
Liver disorder
Liver function test abnormal
Liver function test increased
Liver injury
Local swelling
Localised infection
Loss of consciousnesspassing out
Loss of libido
Loss of personal independence in daily activities
Low birth weight baby
Low density lipoprotein increased
Lower gastrointestinal haemorrhage
Lower limb fracture
Lower respiratory tract infectiona chest infection
Lung disordera lung problem, type not specified
Lung infection
Lung infiltration
Lung neoplasm malignantlung cancer
Lupus-like syndromelupus-like symptoms
Lymphadenopathyswollen lymph nodes
Lymphocyte count decreased
Lymphoedema
Lymphomaa cancer of the lymphatic system
Lymphopenia
Macular degenerationa disease of the central retina
Macular oedema
Madarosis
Major depressionmajor depression
Malabsorption
Malaisegeneral feeling of being unwell
Malignant melanomamelanoma, a skin cancer
Malignant neoplasm progression
Malnutrition
Mania
Mass
Maternal drugs affecting foetus
Maternal exposure before pregnancy
Maternal exposure during pregnancythe mother took the medicine during pregnancy
Medical device complicationa complication with the device
Medication errora mistake in prescribing, dispensing or taking a medicine
Melaenablack tarry stools
Memory impairmentmemory problems
Meningioma
Meningitis
Meniscus injury
Menorrhagiaheavy periods
Menstrual disorder
Menstruation delayed
Menstruation irregularirregular periods
Mental disorder
Mental impairmentreduced thinking ability
Mental status changes
Metabolic acidosistoo much acid in the body fluids
Metabolic disorder
Metastases to bone
Metastases to central nervous system
Metastases to liver
Metastases to lung
Metastases to lymph nodes
Metastasis
Metrorrhagia
Micturition urgency
Middle insomnia
Migrainemigraine
Miosis
Mitral valve incompetence
Mobility decreasedreduced ability to move about
Mood altereda change in mood
Mood swingsmood swings
Motor dysfunction
Mouth haemorrhage
Mouth swelling
Mouth ulcerationmouth ulcers
Movement disorder
Mucosal inflammation
Multi-organ failure
Multiple allergies
Multiple fractures
Multiple injuries
Multiple organ dysfunction syndromeseveral organs failing
Multiple sclerosis
Multiple sclerosis relapsea flare of multiple sclerosis
Multiple use of single-use product
Muscle atrophy
Muscle disorder
Muscle injury
Muscle rigidity
Muscle spasmsmuscle cramps
Muscle spasticity
Muscle strain
Muscle tightness
Muscle twitching
Muscular weaknessmuscle weakness
Musculoskeletal chest pain
Musculoskeletal discomfort
Musculoskeletal disorder
Musculoskeletal painpain in muscles or bones
Musculoskeletal stiffnessstiffness in muscles or joints
Myalgiamuscle pain
Myasthenia gravis
Mydriasis
Myelodysplastic syndrome
Myelosuppression
Myocardial infarctionheart attack
Myocardial ischaemia
Myocarditisinflammation of the heart muscle
Myoclonus
Myopathy
Myositis
Nail disorder
Nasal congestiona blocked nose
Nasal discomfort
Nasal dryness
Nasopharyngitisa cold
Nauseafeeling sick
Neck painneck pain
Necrosisdeath of tissue
Needle issuea problem with the needle
Neoplasm
Neoplasm malignanta cancer, type not specified
Neoplasm progression
Nephrolithiasiskidney stones
Nephropathy
Nephropathy toxic
Nephrotic syndrome
Nerve compression
Nerve injury
Nervous system disorder
Nervousnessnervousness
Neuralgia
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity
Neurological symptom
Neuropathy peripheralnerve damage in hands or feet
Neurotoxicity
Neutropenialow neutrophils, a type of white blood cell
Neutropenic sepsis
Neutrophil count decreased
Neutrophil count increased
Neutrophilia
Nicotine dependence
Night sweatssweating at night
Nightmarenightmares
No adverse eventno adverse event was reported
No therapeutic response
Nocturia
Nodule
Nonspecific reaction
Normal newborn
Nystagmus
Obesity
Obsessive-compulsive disorder
Obstructive airways disorder
Occupational exposure to product
Ocular discomfort
Ocular hyperaemiaa red eye
Odynophagia
Oedemaswelling from fluid
Oedema peripheralswelling of the legs, ankles or hands
Oesophageal carcinoma
Oesophagitis
Off label useused for a purpose or in a way not on the label
Oliguria
On and off phenomenon
Onychoclasis
Optic neuritis
Oral candidiasisoral thrush
Oral discomfort
Oral disorder
Oral herpesa cold sore
Oral mucosal blistering
Oral pain
Oropharyngeal discomfort
Oropharyngeal painsore throat
Orthostatic hypotension
Osteoarthritis
Osteomyelitis
Osteonecrosis
Osteonecrosis of jawdeath of jaw bone tissue
Osteopenia
Osteoporosisthinning of the bones
Ovarian cancer
Ovarian cysta cyst on an ovary
Overdosea dose above the recommended amount
Overweight
Oxygen saturation decreased
Painpain, site not specified
Pain in extremitypain in an arm or leg
Pain in jaw
Pain of skin
Pallor
Palmar-plantar erythrodysaesthesia syndrome
Palpitationsawareness of the heartbeat
Pancreatic carcinoma
Pancreatitisinflammation of the pancreas
Pancreatitis acute
Pancytopenialow counts of all blood cells
Panic attacka panic attack
Panic reaction
Papule
Paraesthesiatingling or pins and needles
Paraesthesia oral
Paralysis
Paranoiaparanoia
Parkinson's disease
Parkinsonism
Parosmia
Partial seizures
Pathogen resistance
Pelvic fracture
Pelvic pain
Pemphigoid
Pemphigus
Pericardial effusionfluid around the heart
Pericarditisinflammation of the sac around the heart
Periorbital oedema
Periorbital swelling
Peripheral coldness
Peripheral sensory neuropathy
Peripheral swellingswelling of the arms or legs
Peripheral vascular disorder
Peritoneal dialysis complication
Peritonitis
Peritonitis bacterial
Peroneal nerve palsy
Personality change
Petechiaetiny bleeding spots in the skin
Petit mal epilepsy
Pharmaceutical product complaint
Pharyngeal oedemaswelling of the throat
Pharyngeal swelling
Pharyngitisa sore throat infection
Pharyngitis streptococcal
Pharyngolaryngeal pain
Phlebitis
Photophobiasensitivity to light
Photopsia
Photosensitivity reactionskin reaction to sunlight
Pigmentation disorder
Plasma cell myeloma
Platelet count abnormal
Platelet count decreasedlow platelet count
Platelet count increased
Pleural effusionfluid around the lung
Pleurisy
Pneumocystis jirovecii pneumonia
Pneumonialung infection
Pneumonia aspirationlung infection from breathing in material
Pneumonia bacterial
Pneumonitis
Pneumothoraxa collapsed lung
Poisoning
Poisoning deliberate
Pollakiuriapassing urine more often
Polyarthritis
Polyneuropathy
Polyp
Polyuria
Poor quality device used
Poor quality drug administered
Poor quality product administered
Poor quality sleep
Poor venous access
Post procedural complicationa complication after a procedure
Post procedural haemorrhage
Post procedural infection
Post-traumatic stress disorder
Posterior reversible encephalopathy syndrome
Postoperative wound infection
Pre-existing condition improved
Pregnancypregnancy
Pregnancy with contraceptive device
Premature babya baby born early
Premature delivery
Premature labour
Prescribed overdose
Prescribed underdose
Prescription drug used without a prescription
Presyncope
Procedural complication
Procedural painpain from a procedure
Proctalgia
Product adhesion issue
Product administered at inappropriate site
Product administered to patient of inappropriate age
Product administration errora mistake in giving the product
Product administration interrupted
Product availability issuethe product was not available
Product colour issuethe product was an odd colour
Product communication issue
Product complaint
Product container issuea problem with the container
Product dispensing error
Product distribution issue
Product dose omissiona dose was missed
Product dose omission in error
Product dose omission issuea dose was missed
Product formulation issue
Product label confusion
Product label issuea problem with the label
Product leakage
Product odour abnormalthe product smelt odd
Product packaging issuea problem with the packaging
Product packaging quantity issue
Product physical consistency issue
Product physical issuea physical defect in the product
Product preparation error
Product preparation issuea problem preparing the product
Product prescribing error
Product prescribing issue
Product quality issuea problem with the product itself
Product residue present
Product size issue
Product storage errorthe product was stored wrongly
Product substitution issuea problem after switching products
Product supply issue
Product taste abnormalthe product tasted odd
Product use complaint
Product use in unapproved indicationused for a purpose not on the label
Product use issuea problem in how the product was used
Productive cougha cough with phlegm
Progressive multifocal leukoencephalopathyPML, a rare brain infection
Prostate cancer
Prostatic disorder
Prostatic specific antigen increased
Proteinuriaprotein in the urine
Prothrombin time prolonged
Pruritusitching
Pruritus generalised
Pseudomonas infection
Psoriasispsoriasis, a skin condition
Psoriatic arthropathy
Psychiatric symptom
Psychological trauma
Psychomotor hyperactivity
Psychotic disordera loss of contact with reality
Pulmonary alveolar haemorrhage
Pulmonary arterial hypertension
Pulmonary congestion
Pulmonary embolisma blood clot in the lung
Pulmonary fibrosis
Pulmonary haemorrhage
Pulmonary hypertensionhigh pressure in the lung arteries
Pulmonary mass
Pulmonary oedemafluid in the lungs
Pulmonary thrombosis
Pulmonary toxicity
Purpura
Pyelonephritis
Pyrexiafever
Quality of life decreasedreduced quality of life
Rales
Rashskin rash
Rash erythematousa red rash
Rash generalised
Rash macular
Rash maculo-papulara rash of flat and raised spots
Rash papular
Rash pruritican itchy rash
Rash pustular
Rebound effect
Recalled product administered
Rectal haemorrhage
Red blood cell count decreased
Red blood cell sedimentation rate increased
Refusal of treatment by patient
Renal cancer
Renal cyst
Renal disorder
Renal failurekidney failure
Renal failure acute
Renal failure chronic
Renal impairmentreduced kidney function
Renal injury
Renal pain
Renal tubular necrosis
Respiration abnormal
Respiratory arrestbreathing stopped
Respiratory depressionslow or shallow breathing
Respiratory disorder
Respiratory distressdifficulty breathing
Respiratory failurethe lungs could not supply enough oxygen
Respiratory rate increased
Respiratory syncytial virus infection
Respiratory tract congestion
Respiratory tract infectiona respiratory infection
Restless legs syndrome
Restlessnessrestlessness
Retching
Retinal detachmentthe retina separated from the back of the eye
Retinal haemorrhage
Rhabdomyolysismuscle breakdown
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease
Rheumatoid factor positive
Rhinitis
Rhinorrhoeaa runny nose
Rib fracture
Right ventricular failure
Road traffic accidenta road accident
Rotator cuff syndrome
Salivary hypersecretion
SARS-CoV-2 test positive
Scab
Scara scar
Schizophreniaschizophrenia
Sciatica
Scoliosis
Scratch
Screaming
Seasonal allergy
Second primary malignancy
Secretion discharge
Sedationdrowsiness
Seizurea fit or convulsion
Sensation of foreign body
Sensitive skin
Sensitivity to weather change
Sensory disturbancea change in sensation
Sensory loss
Sepsisa severe body-wide response to infection
Septic shockshock arising from infection
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor
Serum ferritin increased
Sexual dysfunctiona sexual problem
Shockshock, a collapse of the circulation
Shock haemorrhagic
Sickle cell anaemia with crisis
Sinus bradycardia
Sinus congestion
Sinus disorder
Sinus headache
Sinus tachycardia
Sinusitissinus infection
Skeletal injury
Skin atrophy
Skin burning sensationburning skin
Skin cancerskin cancer
Skin discolourationa change in skin colour
Skin disorder
Skin exfoliationpeeling skin
Skin fissures
Skin haemorrhage
Skin hyperpigmentation
Skin infection
Skin irritationirritated skin
Skin lacerationa cut in the skin
Skin lesion
Skin mass
Skin necrosisdeath of skin tissue
Skin plaque
Skin reaction
Skin swelling
Skin toxicity
Skin ulceran open sore on the skin
Skin warm
Sleep apnoea syndromepauses in breathing during sleep
Sleep disordera sleep problem
Sleep disorder due to a general medical condition
Sleep disorder due to general medical condition, insomnia type
Sluggishness
Small intestinal obstruction
Sneezing
Social avoidant behaviour
Somnambulism
Somnolencedrowsiness
Sopor
Speech disordera speech problem
Spinal compression fracture
Spinal disorder
Spinal fracturea broken bone in the spine
Spinal operation
Spinal osteoarthritis
Spinal painspinal pain
Splenomegaly
Sputum discoloured
Squamous cell carcinoma
Squamous cell carcinoma of skin
Staphylococcal infection
Status epilepticus
Stent placement
Stevens-Johnson syndromea severe skin and mucous-membrane reaction
Stomach discomfort
Stomatitissore mouth
Streptococcal infection
Stressstress
Stress cardiomyopathy
Stress fracture
Subarachnoid haemorrhage
Subdural haematoma
Substance abuse
Sudden deatha sudden death
Suicidal ideationthoughts of suicide
Suicide attempta suicide attempt
Sunburnsunburn
Supraventricular tachycardia
Surgeryan operation
Swellingswelling
Swelling facea swollen face
Swelling of eyelid
Swollen tongue
Symptom recurrence
Syncopefainting
Synovitis
Syringe issue
Systemic lupus erythematosuslupus, an autoimmune disease
Tachycardiafast heart rate
Tachypnoea
Tardive dyskinesiainvoluntary repetitive movements
Taste disorder
Temperature intolerance
Tenderness
Tendon disorder
Tendon pain
Tendon rupturea torn tendon
Tendonitisinflammation of a tendon
Tension
Terminal state
Therapeutic product effect decreased
Therapeutic product effect incomplete
Therapeutic response changed
Therapeutic response decreasedthe medicine worked less well
Therapeutic response shortened
Therapeutic response unexpected
Therapy cessation
Therapy change
Therapy interrupted
Therapy non-responderthe treatment did not work
Therapy partial responder
Thermal burna burn from heat
Thinking abnormal
Thirst
Throat irritationan irritated throat
Throat tightnessa tight throat
Thrombocytopenialow platelets
Thrombosis
Thrombotic microangiopathy
Thyroid cancer
Thyroid disorder
Tic
Tinnitusringing in the ears
Toe amputation
Tongue disorder
Tonsillitis
Tooth abscess
Tooth disordera dental problem
Tooth extraction
Tooth fracture
Tooth infection
Tooth loss
Toothachetooth pain
Torsade de pointesa serious irregular heart rhythm
Toxic epidermal necrolysisa severe skin reaction with peeling
Toxic skin eruption
Toxicity to various agentspoisoning or toxic effect of one or more substances
Transaminases increased
Transfusion
Transient ischaemic attack
Transplant rejection
Treatment failurethe treatment did not work
Treatment noncompliancethe treatment was not taken as directed
Tremorshaking
Tricuspid valve incompetence
Trismus
Troponin increased
Tuberculosistuberculosis
Tubulointerstitial nephritis
Tumour lysis syndrome
Type 1 diabetes mellitustype 1 diabetes
Type 2 diabetes mellitustype 2 diabetes
Ulcer
Ulcer haemorrhage
Underdoseless than the intended dose
Unevaluable eventthe event could not be assessed
Unintended pregnancy
Unintentional medical device removal
Unresponsive to stimuli
Upper gastrointestinal haemorrhage
Upper limb fracture
Upper respiratory tract infectiona cold or similar infection
Upper-airway cough syndrome
Urinary incontinenceleaking urine
Urinary retentionbeing unable to empty the bladder
Urinary tract infectionbladder or urinary infection
Urine odour abnormal
Urine output decreased
Urosepsis
Urticariahives
Uterine cancer
Uterine leiomyoma
Uterine perforationa hole in the wall of the womb
Uveitis
Vaginal discharge
Vaginal haemorrhagevaginal bleeding
Varicose vein
Vasculitisinflammation of blood vessels
Ventricular extrasystoles
Ventricular fibrillationa chaotic rhythm from the lower heart chambers
Ventricular septal defect
Ventricular tachycardiaa fast rhythm from the lower heart chambers
Vertigoa spinning sensation
Viral infectiona viral infection
Virologic failure
Vision blurredblurred vision
Visual acuity reducedreduced sharpness of vision
Visual disturbance
Visual field defect
Visual impairmentreduced vision
Vitamin D decreased
Vitamin D deficiencylow vitamin D
Vitreous floatersfloaters in vision
Vomitingbeing sick
Vulvovaginal burning sensation
Walking aid user
Weight decreasedweight loss
Weight fluctuation
Weight increasedweight gain
Wheezingwheezing
White blood cell count abnormal
White blood cell count decreasedlow white cell count
White blood cell count increased
Withdrawal syndrome
Wound
Wound infectionan infected wound
Wrist fracturea broken wrist
Wrong drug administeredthe wrong medicine was given
Wrong product administered
Wrong technique in device usage process
Wrong technique in drug usage processthe medicine was used in the wrong way
Wrong technique in product usage processthe product was used in the wrong way