Adverse Event Glossary

A

Abdominal Discomfort: A general unease or mild pain in the belly area.
Abdominal Distension: A swelling or bloating of the belly.
Abdominal Pain: Pain in the belly or stomach area.
Abdominal Pain Upper: Pain in the upper part of the belly, above the navel.
Abnormal Behaviour: A report of behavior that is unusual for the person. The term records what was reported and does not establish that a medication was the cause. Also spelled behavior in American English.
Abortion Spontaneous: The medical term for a miscarriage, the unplanned loss of a pregnancy.
Accidental Exposure to Product: A report that someone was unintentionally exposed to a medication, for example a child or another person who was not the patient. This is a safety-tracking category.
Accidental Underdose: A report that less of a medication was taken than intended, by accident. This is a usage category.
Acne: A skin condition causing pimples, usually on the face, chest, or back.
Acute Graft Versus Host Disease: A form of graft versus host disease that occurs soon after a transplant, where donated cells attack the recipient's body.
Acute Kidney Injury: A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Adverse Drug Reaction: A general report of a harmful or unintended response to a medication, used when no more specific reaction is named.
Adverse Event: A general report of an unwanted medical occurrence during medication use, used when no more specific event is named.
Aggression: A report of hostile or aggressive behavior. The term records what was reported and does not establish that a medication was the cause.
Agitation: A state of restlessness, irritability, or feeling unable to settle.
Akathisia: A feeling of inner restlessness and an inability to stay still, sometimes associated with certain medications.
Alanine Aminotransferase Increased: A blood test result showing a higher than normal level of ALT, a liver enzyme. It can be a sign the liver is under stress.
Alopecia: Hair loss.
Anaemia: A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Anaphylactic Reaction: A severe, rapid allergic reaction that can be life-threatening and needs emergency care.
Angina Pectoris: Chest pain caused by reduced blood flow to the heart, usually felt as pressure or tightness.
Anhedonia: A reduced ability to feel pleasure or interest in activities once enjoyed.
Anti-Cyclic Citrullinated Peptide Antibody Positive: A blood test result that can support a diagnosis of rheumatoid arthritis. It often appears in reports because it relates to a condition being treated.
Anxiety: A feeling of worry, nervousness, or unease.
Application Site Erythema: Redness of the skin where a medication was applied, such as under a patch or cream. Erythema means skin redness.
Application Site Irritation: Irritation of the skin where a medication was applied, such as under a patch or cream.
Application Site Pain: Pain at the spot where a medication was applied, such as under a patch.
Application Site Pruritus: Itching of the skin where a medication was applied, such as under a patch or cream. Pruritus means itching.
Application Site Rash: A rash on the skin where a medication was applied, such as under a patch or cream.
Arthralgia: Joint pain.
Arthritis: Inflammation of one or more joints, causing pain and stiffness. It often appears in reports as a condition being treated.
Arthropathy: Any disease or disorder of a joint.
Ascites: A buildup of fluid in the belly, which can cause swelling and discomfort.
Aspartate Aminotransferase Increased: A blood test result showing a higher than normal level of AST, an enzyme found in the liver and other tissues. It can be a sign the liver is under stress.
Asthenia: Physical weakness or lack of strength.
Asthma: A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Atrial Fibrillation: An irregular, often rapid heart rhythm.

B

Back Pain: Pain anywhere along the back.
Balance Disorder: Difficulty staying steady, often with a feeling of unsteadiness or near-falling.
Blister: A small pocket of fluid that forms under the skin.
Blood Cholesterol Increased: A blood test result showing a higher than normal cholesterol level.
Blood Creatinine Increased: A blood test result showing a higher than normal level of creatinine, which can be a sign the kidneys are not filtering as well as usual.
Blood Glucose Abnormal: A blood test result showing a blood sugar level outside the normal range, either high or low.
Blood Glucose Decreased: A blood test result showing a lower than normal blood sugar level. The opposite of blood glucose increased.
Blood Glucose Fluctuation: Blood sugar levels that swing up and down rather than staying steady.
Blood Glucose Increased: A blood test result showing a higher than normal blood sugar level.
Blood Pressure Increased: A reading showing higher than normal blood pressure. Similar to hypertension, which describes the ongoing condition.
Bone Pain: Pain felt in or coming from the bones.
Bradycardia: A slower than normal heart rate.
Breast Cancer: A cancer that forms in the tissue of the breast. It may appear in reports as a condition being treated or monitored.
Breast Cancer Female: A report of breast cancer in a female patient. It may appear in reports as a condition being treated or monitored, not necessarily as a reaction.
Breast Cancer Metastatic: Breast cancer that has spread to other parts of the body. It may appear in reports as a condition being treated.
Bronchitis: Inflammation of the airways that carry air to the lungs, often causing a cough.

C

Cardiac Arrest: A sudden stop in the heart's pumping, a medical emergency.
Cardiac Disorder: A general report of a problem with the heart, used when no more specific condition is named.
Cardiac Failure: A condition where the heart cannot pump blood as well as it should, often called heart failure.
Cardiac Failure Congestive: A form of heart failure, often called congestive heart failure, where the heart cannot pump blood as well as it should, leading to fluid buildup.
Cardio-Respiratory Arrest: A sudden stop in both heartbeat and breathing. It is a medical emergency.
Cataract: A clouding of the lens of the eye that can blur vision.
Cerebrovascular Accident: The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Chest Discomfort: A feeling of unease, tightness, or mild pain in the chest. Related to chest pain, and like chest pain it is worth discussing with a doctor.
Chest Pain: Pain or discomfort in the chest. Chest pain has many causes, but it is always worth taking seriously and discussing with a doctor.
Chills: A feeling of coldness, often with shivering, which can accompany a fever.
Chronic Kidney Disease: A long-term, gradual loss of kidney function over months or years.
Chronic Obstructive Pulmonary Disease: A long-term lung condition, often called COPD, that makes breathing difficult. It often appears in reports as a condition being treated.
Cognitive Disorder: A problem affecting thinking abilities such as memory, attention, or reasoning.
Colitis Ulcerative: A long-term condition, usually called ulcerative colitis, that causes inflammation and sores in the lining of the large intestine. It often appears in reports as a condition being treated.
Coma: A prolonged state of deep unconsciousness.
Completed Suicide: A report that a person died by suicide. This is recorded in adverse event data when it occurs during medication use, and its presence does not establish that the drug was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Condition Aggravated: A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Confusional State: A state of being confused, disoriented, or unable to think clearly.
Constipation: Difficulty passing stool, or having fewer bowel movements than usual.
Contraindicated Product Administered: A report that a medication was given in a situation where it was not recommended, for example when another condition made it unsuitable. This is a reporting category describing what happened, not a measure of harm by itself.
Contusion: The medical term for a bruise.
Convulsion: Uncontrolled shaking of the body caused by sudden muscle contractions, often associated with a seizure.
Coronary Artery Disease: A narrowing of the arteries that supply blood to the heart. It often appears in reports as a condition being treated.
Cough: A reflex that clears the throat or airways.
COVID-19: The illness caused by the SARS-CoV-2 coronavirus.
Crohn's Disease: A long-term condition that causes inflammation of the digestive tract. It often appears in reports as a condition being treated.
Cytomegalovirus Infection: An infection with a common virus, often called CMV, that can be serious for people with weakened immune systems.

D

Death: A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Decreased Appetite: Reduced desire to eat.
Deep Vein Thrombosis: A blood clot that forms in a deep vein, usually in the leg. It can be serious if the clot travels to the lungs.
Dehydration: A condition where the body does not have enough water.
Dependence: A state in which the body or mind has come to rely on a substance, so that stopping it causes difficulty. Closely related to drug dependence.
Depressed Level of Consciousness: Reduced alertness or awareness, ranging from drowsiness to difficulty staying awake.
Depression: A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Device Adhesion Issue: A report that a device meant to stick to the skin did not adhere properly. This is a product-performance category.
Device Issue: A general report of a problem with a medical device, used when no more specific issue is named.
Device Malfunction: A report that a medical device did not work as intended.
Diabetes Mellitus: A condition where the body cannot properly regulate blood sugar, commonly called diabetes.
Diabetes Mellitus Inadequate Control: A report that a person's diabetes was not well managed, meaning blood sugar stayed outside the target range.
Diabetic Ketoacidosis: A serious complication of diabetes where the blood becomes too acidic, needing urgent medical care.
Diarrhoea: Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Discomfort: A general feeling of being physically uneasy or unwell, used when no more specific symptom is given.
Disease Progression: A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Disturbance in Attention: Difficulty concentrating or staying focused.
Dizziness: A feeling of being lightheaded, unsteady, or like the room is spinning.
Drug Abuse: A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Drug Administration Error: A report that a medication was given or taken incorrectly in some way. This is a usage category.
Drug Dependence: A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Drug Dose Omission: A report that a dose of medication was missed or skipped.
Drug Dose Omission by Device: A report that a dose was missed because a device, such as a pump or injector, did not deliver it. This is a usage and device category.
Drug Exposure During Pregnancy: A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Drug Hypersensitivity: An allergic-type reaction to a medication.
Drug Ineffective: A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Drug Ineffective for Unapproved Indication: A report that a medication did not work when used for a condition it is not officially approved to treat. This is a reporting category, not a sign the drug is defective.
Drug Interaction: A report that two or more medications may have affected each other when taken together.
Drug Intolerance: A report that the person could not tolerate a medication, often due to uncomfortable effects.
Drug Reaction with Eosinophilia and Systemic Symptoms: A rare but serious reaction to a medication, sometimes called DRESS, involving rash, fever, and effects on internal organs.
Drug Resistance: A situation where a medication becomes less effective against the condition it was meant to treat, such as an infection no longer responding to an antibiotic.
Drug Withdrawal Syndrome: The set of symptoms that can occur when a medication the body has gotten used to is stopped or reduced.
Drug Withdrawal Syndrome Neonatal: Withdrawal symptoms in a newborn whose mother took certain medications during pregnancy.
Dry Eye: A lack of enough tears to keep the eye comfortable, causing dryness or irritation.
Dry Mouth: A lack of saliva that makes the mouth feel dry.
Dry Skin: Skin that lacks moisture, which can feel rough, tight, or flaky.
Duodenal Ulcer Perforation: A serious complication where an ulcer in the upper part of the small intestine creates a hole through the wall. It needs urgent medical care.
Dysgeusia: A distorted or altered sense of taste, such as a persistent metallic taste.
Dyskinesia: Involuntary, uncontrolled movements of the body.
Dyspepsia: The medical term for indigestion, meaning discomfort or pain in the upper belly, often after eating.
Dysphagia: Difficulty swallowing.
Dysphonia: Difficulty speaking, such as hoarseness or a change in the voice.
Dyspnoea: Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Dyspnoea Exertional: Shortness of breath that happens during physical activity. A specific form of dyspnoea. Also spelled dyspnea in American English.
Dystonia: Involuntary muscle contractions that cause twisting movements or abnormal postures.

E

Economic Problem: A report noting a financial difficulty, such as trouble affording a medication. This is a non-medical category sometimes recorded in reports.
Electrocardiogram QT Prolonged: A heart test result showing a longer than normal pause in the heart's electrical cycle, which can affect heart rhythm.
Emotional Distress: A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
End Stage Renal Disease: The final stage of chronic kidney disease, where the kidneys can no longer function well enough to sustain the body without dialysis or a transplant. Renal means related to the kidneys.
Epilepsy: A condition of the brain that causes repeated seizures. It often appears in reports as a condition being treated.
Epistaxis: The medical term for a nosebleed.
Epstein-Barr Virus Infection: An infection with a common virus, often called EBV, that causes mononucleosis (mono).
Erectile Dysfunction: Difficulty getting or keeping an erection.
Eructation: The medical term for belching or burping.
Erythema: Redness of the skin.
Expired Product Administered: A report that a medication was used after its expiration date. This is a handling category, not a sign of a problem with the drug itself.
Exposure During Pregnancy: A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Extra Dose Administered: A report that more doses of a medication were taken than directed. This is a usage category.
Extrapyramidal Disorder: A group of movement problems, such as stiffness, tremor, or restlessness, that can be associated with certain medications.
Eye Irritation: Discomfort, redness, or itching of the eye.
Eye Pain: Pain in or around the eye.

F

Fall: A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Fatigue: Extreme tiredness or lack of energy that does not improve with rest.
Febrile Neutropenia: A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Feeling Abnormal: A general report that the person did not feel like themselves, without a more specific description.
Fibromyalgia: A condition causing widespread muscle pain, fatigue, and tenderness. It often appears in reports as a condition being treated.
Flatulence: Excess gas in the digestive system, commonly called passing gas.
Fluid Retention: A buildup of excess fluid in the body, which can cause swelling.
Flushing: A sudden reddening and warmth of the skin, usually of the face and neck.
Foetal Exposure During Pregnancy: A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full Blood Count Abnormal: A blood test result showing one or more values outside the normal range.

G

Gait Disturbance: Difficulty walking normally, such as an unsteady or altered way of walking.
Gastrointestinal Disorder: A general report of a problem affecting the digestive system, used when no more specific condition is named.
Gastrointestinal Haemorrhage: Bleeding somewhere in the digestive tract, such as the stomach or intestines. Also spelled hemorrhage in American English.
Gastrooesophageal Reflux Disease: A condition, often called acid reflux or GERD, where stomach acid flows back into the food pipe, causing heartburn. Also spelled gastroesophageal in American English.
General Physical Health Deterioration: A report that the person's overall physical health declined.
Generalised Tonic-Clonic Seizure: A type of seizure involving loss of consciousness and full-body muscle stiffening and jerking, once called a grand mal seizure. Also spelled generalized in American English.
Glossodynia: Pain or a burning sensation in the tongue.
Glycosylated Haemoglobin Increased: A higher than normal result on the HbA1c blood test, which reflects average blood sugar over the past few months. Also spelled hemoglobin in American English.
Graft Versus Host Disease: A complication that can occur after a transplant, where donated cells attack the recipient's body.

H

Haemoglobin Decreased: A blood test result showing a low level of haemoglobin, the protein in red blood cells that carries oxygen. This is closely related to anaemia. Also spelled hemoglobin in American English.
Haemorrhage: Bleeding, particularly heavy or uncontrolled bleeding. Also spelled hemorrhage in American English.
Hair Colour Changes: A change in hair color. Also spelled color in American English.
Hair Texture Abnormal: A change in the feel or quality of the hair, such as becoming brittle or coarse.
Hallucination: Seeing, hearing, or sensing things that are not actually there. The term records what was reported and does not establish that a medication was the cause.
Hallucination, Auditory: Hearing sounds or voices that are not actually there. The term records what was reported and does not establish that a medication was the cause.
Hand Deformity: A change in the normal shape or structure of the hand.
Headache: Pain in the head or upper neck.
Heart Rate Increased: A reading showing a faster than normal heartbeat. Similar to tachycardia, which is the clinical term for the condition.
Helicobacter Infection: An infection with Helicobacter pylori, a bacterium that can cause stomach ulcers.
Hepatic Enzyme Increased: A blood test result showing higher than normal liver enzymes, which can be a sign the liver is under stress. Hepatic means related to the liver.
Hospitalisation: A report that the person was admitted to a hospital. This records that a hospital stay occurred, which is one way the seriousness of an event is tracked. Also spelled hospitalization in American English.
Hot Flush: A sudden feeling of heat, often in the face and upper body, sometimes with sweating. Often called a hot flash in American English.
Hyperglycaemia: A high level of sugar in the blood. Also spelled hyperglycemia in American English.
Hyperhidrosis: Excessive sweating.
Hyperkalaemia: A high level of potassium in the blood. Also spelled hyperkalemia in American English.
Hypersensitivity: An exaggerated reaction by the immune system, similar to an allergic reaction.
Hypertension: High blood pressure.
Hypoaesthesia: Reduced sense of touch or numbness in part of the body. Also spelled hypoesthesia in American English.
Hypoglycaemia: A low level of sugar in the blood, which can cause shakiness, sweating, and confusion. Also spelled hypoglycemia in American English.
Hypokalaemia: A low level of potassium in the blood. Also spelled hypokalemia in American English.
Hyponatraemia: A low level of sodium in the blood. Also spelled hyponatremia in American English.
Hypotension: Low blood pressure.

I

Ill-Defined Disorder: A reported condition that could not be clearly identified or categorized. This is a record-keeping category.
Illness: A general report of being unwell, used when no more specific condition is given.
Impaired Healing: Wounds or injuries that heal more slowly than expected.
Inappropriate Schedule of Drug Administration: A report that a medication was taken on the wrong schedule, such as too often or at the wrong time. This is a usage category, the same idea as inappropriate schedule of product administration.
Inappropriate Schedule of Product Administration: A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Incorrect Dose Administered: A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Incorrect Drug Administration Duration: A report that a medication was taken for a longer or shorter time than directed. This is a usage category.
Infection: A general report of an infection, used when no more specific type is given.
Influenza: The flu, a viral infection of the respiratory system.
Influenza Like Illness: A set of symptoms resembling the flu, such as fever, aches, and tiredness, without a confirmed flu diagnosis.
Infusion Related Reaction: A reaction that happens during or shortly after a medication is given through an IV infusion.
Infusion Site Pain: Pain at the spot where a medication was given through an IV infusion.
Injection Site Bruising: Bruising at the spot where a medication was injected.
Injection Site Erythema: Redness of the skin at the spot where a medication was injected. Erythema means skin redness.
Injection Site Haemorrhage: Bleeding at the spot where a medication was injected. Also spelled hemorrhage in American English.
Injection Site Mass: A lump that forms at the spot where a medication was injected.
Injection Site Pain: Pain at the spot on the body where a medication was injected.
Injection Site Reaction: A general report of a reaction at the spot where a medication was injected, such as redness, swelling, or pain.
Injection Site Swelling: Swelling at the spot where a medication was injected.
Injury: A general report of physical harm to the body, used when no more specific type is given.
Insomnia: Difficulty falling asleep or staying asleep.
Insurance Issue: A report noting a problem related to insurance coverage, such as difficulty getting a medication covered. This is a non-medical category sometimes recorded in reports.
Intentional Drug Misuse: A report that a medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Intentional Overdose: A report that a person deliberately took more of a medication than prescribed. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Intentional Product Misuse: A report that a medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Intentional Product Use Issue: A report that the medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Interstitial Lung Disease: A group of conditions that cause scarring or inflammation of the lung tissue, which can make breathing harder.
Irritability: A tendency to become annoyed or frustrated more easily than usual.

J

Joint Swelling: Swelling in or around a joint.

L

Leukopenia: A low level of white blood cells, which help fight infection. Closely related to neutropenia, which is a low level of one specific type of white blood cell.
Loss of Consciousness: Fainting or passing out, a temporary loss of awareness.
Loss of Personal Independence in Daily Activities: A report that a person became less able to carry out everyday tasks on their own.
Lower Respiratory Tract Infection: An infection affecting the airways and lungs, below the throat, such as bronchitis or pneumonia.

M

Macular Degeneration: An eye condition that affects central vision, more common with age. It may appear in reports as a condition being treated.
Malaise: A general feeling of being unwell or uncomfortable, without a specific symptom.
Malignant Neoplasm Progression: A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Maternal Exposure During Pregnancy: A report noting that a pregnant person was exposed to a medication. This is a tracking category for monitoring use during pregnancy, not a description of harm by itself.
Memory Impairment: Difficulty remembering things.
Mental Disorder: A general report of a mental health condition, used when no more specific condition is named. The term records what was reported and does not establish that a medication was the cause.
Metastases to Bone: Cancer that has spread to the bones from another part of the body. It may appear in reports as part of a condition being treated.
Metastases to Liver: Cancer that has spread to the liver from another part of the body. It may appear in reports as part of a condition being treated.
Migraine: A severe, often throbbing headache, sometimes with nausea or sensitivity to light and sound.
Mobility Decreased: A reduced ability to move around.
Mucosal Inflammation: Inflammation of the moist linings of the body, such as inside the mouth, nose, or digestive tract.
Multiple Organ Dysfunction Syndrome: A serious condition where two or more organ systems begin to fail, often during severe illness. It needs urgent medical care.
Multiple Sclerosis: A condition where the immune system affects the protective covering of nerves, which can disrupt movement and other functions. It often appears in reports as a condition being treated.
Multiple Sclerosis Relapse: A return or worsening of multiple sclerosis symptoms. It often appears in reports as part of the condition being treated.
Muscle Spasms: Sudden, involuntary tightening of a muscle, often called cramps.
Muscular Weakness: A loss of muscle strength. Similar to asthenia, which is a more general sense of weakness.
Musculoskeletal Stiffness: Stiffness in the muscles, joints, or related tissues.
Myalgia: Muscle pain or aches.
Myelosuppression: A decrease in the bone marrow's production of blood cells, which can lower red cells, white cells, and platelets. Common with some cancer treatments.
Myocardial Infarction: The medical term for a heart attack.

N

Nasal Congestion: A stuffy or blocked nose.
Nasopharyngitis: The medical term for the common cold, an infection of the nose and throat.
Nausea: The feeling of sickness in your stomach that often comes before vomiting.
Neoplasm Malignant: The medical term for a cancerous growth. It may appear in reports as a condition being treated or monitored.
Neoplasm Progression: A report that a tumour grew or advanced. This describes the course of the illness, not necessarily an effect of the drug. Neoplasm is the medical term for a growth or tumour.
Neuroleptic Malignant Syndrome: A rare but serious reaction, usually to certain mental-health medications, involving high fever, muscle stiffness, and confusion. It needs urgent medical care.
Neuropathy Peripheral: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.
Neutropenia: A low level of neutrophils, a type of white blood cell that fights infection.
Neutrophil Count Decreased: A blood test result showing a low level of neutrophils, a type of infection-fighting white blood cell. This is the lab-measurement version of neutropenia.
No Adverse Event: A report that was filed but did not actually describe any adverse event. This is a record-keeping category.

O

Obesity: A condition of having excess body weight that can affect health. It may appear in reports as a condition being treated or monitored.
Oedema: Swelling caused by a buildup of fluid in the body's tissues. Also spelled edema in American English. Related to peripheral swelling.
Oedema Peripheral: Swelling in the arms, legs, hands, or feet caused by fluid buildup. Oedema is also spelled edema in American English.
Off Label Use: Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Oral Pain: Pain inside the mouth.
Oropharyngeal Pain: Pain in the mouth and throat, often felt as a sore throat.
Osteoporosis: A condition where bones become weak and more likely to break. It often appears in reports as a condition being treated.
Overdose: Taking more of a medication than intended or recommended. This can be accidental.
Oxygen Saturation Decreased: A reading showing a lower than normal level of oxygen in the blood.

P

Pain: A general report of physical discomfort, used when no more specific location is given.
Pain in Extremity: Pain in an arm or leg.
Pain in Jaw: Pain felt in the jaw.
Palmar-Plantar Erythrodysaesthesia Syndrome: A skin reaction on the palms and soles, sometimes called hand-foot syndrome, that can occur with some cancer treatments. It causes redness, swelling, and discomfort.
Palpitations: The feeling of a fast, pounding, or fluttering heartbeat.
Pancreatitis: Inflammation of the pancreas, which can cause severe belly pain.
Pancytopenia: A shortage of all three main types of blood cells (red cells, white cells, and platelets) at the same time.
Paraesthesia: An abnormal skin sensation such as tingling, prickling, or a pins and needles feeling. Also spelled paresthesia in American English.
Pemphigus: A rare autoimmune condition that causes blistering of the skin and the moist linings of the body such as the mouth.
Pericarditis: Inflammation of the thin sac surrounding the heart, which can cause chest pain.
Peripheral Swelling: Swelling in the arms, legs, hands, or feet, often from fluid buildup.
Pharmaceutical Product Complaint: A report of a possible problem with a medication's quality, packaging, or condition. This is a quality-tracking category.
Plasma Cell Myeloma: A cancer of certain white blood cells in the bone marrow, also called multiple myeloma. It often appears in reports as a condition being treated.
Platelet Count Decreased: A blood test result showing a low level of platelets, the cells that help blood clot. This is the lab-measurement version of thrombocytopenia.
Pleural Effusion: A buildup of fluid around the lungs, which can make breathing difficult.
Pneumonia: An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Product Adhesion Issue: A report that a medication meant to stick to the skin, such as a patch, did not adhere properly. This is a product-performance category.
Product Dose Omission: A report that a dose of a medication was missed or skipped. Similar to drug dose omission.
Product Dose Omission Issue: A report that a dose of the medication was missed or skipped.
Product Quality Issue: A report of a possible problem with the medication's quality, such as appearance, packaging, or condition. This is a quality-tracking category.
Product Storage Error: A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Product Use in Unapproved Indication: Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Product Use Issue: A general report that there was some problem in how the medication was used.
Productive Cough: A cough that brings up mucus or phlegm, sometimes called a wet cough. A more specific form of cough.
Pruritus: Itching of the skin.
Psoriasis: A condition where skin cells build up and form itchy, scaly patches. It often appears in reports because it is a condition being treated.
Psoriatic Arthropathy: A form of joint disease linked to psoriasis, often called psoriatic arthritis, causing joint pain and swelling. It often appears in reports as a condition being treated.
Psychotic Disorder: A mental health condition involving a loss of contact with reality, which can include hallucinations or delusions. The term records what was reported and does not establish that a medication was the cause.
Pulmonary Arterial Hypertension: High blood pressure in the arteries of the lungs, which makes the heart work harder. It often appears in reports as a condition being treated.
Pulmonary Embolism: A blockage in one of the arteries of the lungs, usually caused by a blood clot. This is a serious condition that needs urgent medical care.
Pulmonary Hypertension: High blood pressure in the blood vessels of the lungs.
Pyrexia: The medical term for fever, meaning a raised body temperature.

R

Rash: An area of irritated, red, or bumpy skin.
Renal Failure: A serious decline in kidney function, where the kidneys can no longer filter waste properly.
Renal Failure Acute: A sudden, serious decline in kidney function. Closely related to acute kidney injury. Renal means related to the kidneys.
Renal Impairment: Reduced kidney function. Renal means related to the kidneys. This is a broad term for kidneys not working as well as normal.
Renal Injury: Damage to the kidneys. Renal means related to the kidneys. Related to acute kidney injury and renal impairment.
Respiratory Failure: A serious condition where the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide.
Rhabdomyolysis: A serious condition where muscle tissue breaks down and releases substances that can harm the kidneys.
Rheumatoid Arthritis: An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.

S

Schizophrenia: A mental health condition that affects how a person thinks, feels, and perceives reality. It often appears in reports as a condition being treated.
Sedation: A state of calm, drowsiness, or reduced alertness.
Seizure: A sudden burst of electrical activity in the brain that can cause shaking, altered awareness, or other temporary changes.
Sepsis: A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Septic Shock: A life-threatening drop in blood pressure caused by a severe infection. It needs urgent medical care.
Serotonin Syndrome: A potentially serious reaction caused by too much serotonin activity, often from combining certain medications. Symptoms can include agitation, rapid heartbeat, and muscle twitching.
Sinusitis: Inflammation of the sinuses, the air-filled spaces around the nose, often causing congestion and pressure.
Skin Exfoliation: Peeling or shedding of the outer layer of skin.
Sleep Disorder Due to a General Medical Condition: Difficulty sleeping that is linked to an underlying health condition.
Somnolence: Drowsiness or strong sleepiness.
Status Epilepticus: A seizure that lasts a long time or repeated seizures without recovery in between. It is a medical emergency.
Stevens-Johnson Syndrome: A rare but serious reaction, often to a medication, that causes the skin to blister and peel. It needs urgent medical care.
Stomatitis: Inflammation or soreness inside the mouth, including the gums, tongue, and inner cheeks.
Stress: A feeling of mental or emotional strain.
Suicidal Ideation: Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Suicide Attempt: A report that a person attempted suicide. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Surgery: A report noting that a surgical procedure occurred. This may be recorded as part of a person's medical history or treatment.
Swelling: A general report of a body part becoming enlarged, often from fluid or inflammation.
Swelling Face: Swelling of the face, which can have many causes including allergic reactions.
Syncope: The medical term for fainting, a brief loss of consciousness usually caused by a temporary drop in blood flow to the brain.
Synovitis: Inflammation of the lining of a joint, causing swelling and pain.
Systemic Lupus Erythematosus: An autoimmune condition, often called lupus, where the immune system attacks the body's own tissues, affecting joints, skin, and organs. It often appears in reports because it is a condition being treated, not always a reaction.

T

Tachycardia: A faster than normal heart rate.
Therapeutic Product Effect Decreased: A report that the medication seemed to work less well than before. Similar to drug ineffective, it reflects a perceived drop in how well the treatment was working.
Therapeutic Product Effect Incomplete: A report that the medication only partly worked. Similar to drug ineffective, it reflects that someone felt the treatment did not fully help.
Therapeutic Response Decreased: A report that a treatment seemed to work less well than before. Similar to drug ineffective and therapeutic product effect decreased.
Therapeutic Response Unexpected: A report that a treatment produced an unexpected response, different from what was anticipated.
Therapy Non-Responder: A report that a person did not respond to a treatment. Similar to drug ineffective, it reflects that the treatment did not produce the expected result.
Throat Irritation: A scratchy or uncomfortable feeling in the throat.
Thrombocytopenia: A low level of platelets, the blood cells that help with clotting.
Thrombosis: The formation of a blood clot inside a blood vessel.
Toxicity to Various Agents: A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Treatment Failure: A report that the treatment did not produce the expected result. Similar to drug ineffective, it reflects that someone felt the treatment was not working.
Treatment Noncompliance: A report that a person did not take a treatment as prescribed. This is a reporting category describing what happened, not a judgment about the person.
Tremor: Involuntary shaking or trembling, often in the hands.
Type 2 Diabetes Mellitus: The most common form of diabetes, where the body does not use insulin properly. It often appears in reports as a condition being treated.

U

Underdose: A report that less of a medication was taken than prescribed. This is a usage category.
Unevaluable Event: A reported event that could not be assessed, usually because there was not enough information. This is a record-keeping category.
Upper Respiratory Tract Infection: An infection of the nose, throat, or sinuses, such as the common cold.
Urinary Tract Infection: An infection in the bladder, urethra, or kidneys, often called a UTI.
Urticaria: The medical term for hives, which are raised, itchy welts on the skin.

V

Vaginal Haemorrhage: Vaginal bleeding, particularly heavy or unexpected bleeding. Also spelled hemorrhage in American English.
Vision Blurred: A loss of sharpness in vision, making things look out of focus.
Visual Acuity Reduced: A decrease in the sharpness of vision.
Visual Impairment: Reduced ability to see.
Vomiting: Throwing up the contents of the stomach.

W

Weight Decreased: Losing body weight.
Weight Increased: Gaining body weight.
Wheezing: A whistling sound when breathing, usually a sign the airways are narrowed.
White Blood Cell Count Decreased: A blood test result showing a low level of white blood cells, which help fight infection.
Withdrawal Syndrome: The symptoms that can occur when a substance the body has gotten used to is reduced or stopped. Related to drug withdrawal syndrome.
Wound: A report of an injury that breaks the skin.
Wrong Technique in Device Usage Process: A report that a device was used with the wrong technique. This is a usage category, the same idea as wrong technique in product usage process.
Wrong Technique in Product Usage Process: A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.