A

Abdominal Discomfort

A general unease or mild pain in the belly area.

Abdominal Pain

Pain in the belly or stomach area.

Abdominal Pain Upper

Pain in the upper part of the belly, above the navel.

Acute Kidney Injury

A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.

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.

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.

Anxiety

A feeling of worry, nervousness, or unease.

Arthralgia

Joint pain.

Arthropathy

Any disease or disorder of a joint.

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.

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.

C

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.

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.

Chronic Kidney Disease

A long-term, gradual loss of kidney function over months or years.

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.

Cough

A reflex that clears the throat or airways.

COVID-19

The illness caused by the SARS-CoV-2 coronavirus.

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.

Dehydration

A condition where the body does not have enough water.

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.

Diarrhoea

Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.

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.

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 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 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 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.

Dyspepsia

The medical term for indigestion, meaning discomfort or pain in the upper belly, often after eating.

Dyspnoea

Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.

E

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.

Erythema

Redness of the skin.

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.

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.

G

Gait Disturbance

Difficulty walking normally, such as an unsteady or altered way of walking.

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.

Glossodynia

Pain or a burning sensation in the tongue.

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.

Headache

Pain in the head or upper neck.

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.

Hyperhidrosis

Excessive sweating.

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.

Hypotension

Low blood pressure.

I

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.

Infection

A general report of an infection, used when no more specific type is given.

Infusion Related Reaction

A reaction that happens during or shortly after a medication is given through an IV infusion.

Injection Site Pain

Pain at the spot on the body where a medication was injected.

Insomnia

Difficulty falling asleep or staying asleep.

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.

J

Joint Swelling

Swelling in or around a joint.

M

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.

Migraine

A severe, often throbbing headache, sometimes with nausea or sensitivity to light and sound.

Mobility Decreased

A reduced ability to move around.

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.

Myocardial Infarction

The medical term for a heart attack.

N

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.

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.

O

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.

Overdose

Taking more of a medication than intended or recommended. This can be accidental.

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.

Palpitations

The feeling of a fast, pounding, or fluttering heartbeat.

Paraesthesia

An abnormal skin sensation such as tingling, prickling, or a pins and needles feeling. Also spelled paresthesia in American English.

Peripheral Swelling

Swelling in the arms, legs, hands, or feet, often from fluid buildup.

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.

Pneumonia

An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.

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 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.

Pruritus

Itching of the skin.

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.

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.

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 Impairment

Reduced kidney function. Renal means related to the kidneys. This is a broad term for kidneys not working as well as normal.

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

Sepsis

A serious, body-wide response to an infection that can become life threatening and needs urgent care.

Sinusitis

Inflammation of the sinuses, the air-filled spaces around the nose, often causing congestion and pressure.

Somnolence

Drowsiness or strong sleepiness.

Stomatitis

Inflammation or soreness inside the mouth, including the gums, tongue, and inner cheeks.

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.

Swelling

A general report of a body part becoming enlarged, often from fluid or inflammation.

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

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.

Thrombocytopenia

A low level of platelets, the blood cells that help with clotting.

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.

Tremor

Involuntary shaking or trembling, often in the hands.

U

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

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.

Wound

A report of an injury that breaks the skin.

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.