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FDA labels and FAERS

Side effects: labels and reports

FAERS reports for 2,014 medicines through July 30, 2026, beside each label's own adverse-reactions text. A FAERS report records that someone took the medicine and something happened. It does not show that the medicine caused it, and counts follow how widely a medicine is used and watched; they are not a measure of how risky it is.

Which medicines list a given side effect?

Each side effect below has the medicines whose FDA labels name it, with their FAERS reports of it.

Abdominal discomfort
200 labels; 164,952 FAERS reports
Abdominal distension
118 labels; 102,599 FAERS reports
Alanine aminotransferase increased
157 labels; 60,625 FAERS reports
Anaphylactic reaction
275 labels; 54,210 FAERS reports
Anxiety
519 labels; 281,524 FAERS reports
Blood glucose increased
25 labels; 186,668 FAERS reports
Blurred vision
473 labels; 134,803 FAERS reports
Bradycardia
310 labels; 52,435 FAERS reports
Burning sensation
95 labels; 69,201 FAERS reports
Chest discomfort
109 labels; 100,642 FAERS reports
Chills
469 labels; 115,869 FAERS reports
Common cold symptoms (nasopharyngitis)
322 labels; 182,291 FAERS reports
Confusional state
109 labels; 159,767 FAERS reports
Constipation
808 labels; 213,553 FAERS reports
Cough
677 labels; 276,102 FAERS reports
Dehydration
219 labels; 131,638 FAERS reports
Diarrhea
1,304 labels; 634,725 FAERS reports
Dizziness
1,279 labels; 491,274 FAERS reports
Drowsiness (somnolence)
657 labels; 198,392 FAERS reports
Dry mouth
485 labels; 79,920 FAERS reports
Dry skin
199 labels; 129,815 FAERS reports
Excessive sweating (hyperhidrosis)
147 labels; 127,260 FAERS reports
Eye irritation
72 labels; 55,016 FAERS reports
Fall
115 labels; 328,092 FAERS reports
Fatigue
920 labels; 766,581 FAERS reports
Febrile neutropenia
121 labels; 65,352 FAERS reports
Fever
1,120 labels; 341,662 FAERS reports
Flushing
418 labels; 100,772 FAERS reports
Gait disturbance
55 labels; 189,412 FAERS reports
Hair loss (alopecia)
451 labels; 194,177 FAERS reports
Headache
1,427 labels; 617,851 FAERS reports
Hemoglobin decreased
187 labels; 101,548 FAERS reports
High blood pressure (hypertension)
684 labels; 209,230 FAERS reports
Hives (urticaria)
1,021 labels; 164,226 FAERS reports
Hypersensitivity
1,005 labels; 182,913 FAERS reports
Insomnia
652 labels; 263,244 FAERS reports
Itching (pruritus)
1,205 labels; 372,958 FAERS reports
Joint pain (arthralgia)
715 labels; 408,880 FAERS reports
Joint swelling
35 labels; 118,886 FAERS reports
Loss of appetite
774 labels; 228,555 FAERS reports
Low blood pressure (hypotension)
760 labels; 197,651 FAERS reports
Muscle pain (myalgia)
624 labels; 167,738 FAERS reports
Muscle spasms
182 labels; 181,134 FAERS reports
Nausea
1,566 labels; 778,547 FAERS reports
Neuropathy peripheral
203 labels; 93,295 FAERS reports
Neutropenia
450 labels; 133,704 FAERS reports
Numbness (hypoesthesia)
419 labels; 147,886 FAERS reports
Ocular hyperemia
31 labels; 46,105 FAERS reports
Pancytopenia
182 labels; 54,990 FAERS reports
Rash
1,495 labels; 427,877 FAERS reports
Shortness of breath (dyspnea)
940 labels; 558,127 FAERS reports
Skin redness (erythema)
576 labels; 202,580 FAERS reports
Swelling of the legs (peripheral edema)
437 labels; 120,715 FAERS reports
Tachycardia
584 labels; 87,678 FAERS reports
Thrombocytopenia
650 labels; 110,037 FAERS reports
Tingling (paresthesia)
663 labels; 155,624 FAERS reports
Tinnitus (ringing in the ears)
294 labels; 45,411 FAERS reports
Tremor
405 labels; 164,064 FAERS reports
Upper abdominal pain
264 labels; 202,727 FAERS reports
Visual impairment
78 labels; 121,401 FAERS reports
Vomiting
1,444 labels; 462,663 FAERS reports
Weakness (asthenia)
1,006 labels; 371,078 FAERS reports
Weight gain
376 labels; 219,853 FAERS reports
Weight loss
365 labels; 275,352 FAERS reports
Wheezing
261 labels; 58,383 FAERS reports

Which medicines have the most reports?

MedicineFAERS reportsPage
Adalimumab712,308Side effects
Etanercept595,129Side effects
Aspirin534,208
Prednisone499,950Side effects
Methotrexate489,791Side effects
Dupilumab478,975Side effects
Omeprazole446,179Side effects
Acetaminophen445,075
Lenalidomide420,082Side effects
Metformin410,076Side effects
Amlodipine409,186Side effects
Furosemide398,354Side effects
Ergocalciferol382,573Side effects
Gabapentin362,654Side effects
Metoprolol353,609Side effects
Omeprazole and sodium bicarbonate342,964
Pantoprazole330,183Side effects
Oxycodone311,625Side effects
Lisinopril304,309Side effects
Dexamethasone304,163Side effects
Levothyroxine300,456Side effects
Albuterol292,136Side effects
Pregabalin270,624Side effects
Ibuprofen270,516
Simvastatin248,728Side effects
Folic acid247,883Side effects
Atorvastatin245,894Side effects
Insulin glargine245,619Side effects
Infliximab243,740Side effects
Esomeprazole235,202
Ranitidine230,803Side effects
Rituximab219,890Side effects
Sertraline218,311Side effects
Clopidogrel211,001Side effects
Rivaroxaban206,938Side effects
Alprazolam204,916Side effects
Denosumab201,378Side effects
Losartan200,566Side effects
Levonorgestrel200,218
Interferon beta 1a192,061Side effects
Quetiapine191,480Side effects
Prednisolone191,407Side effects
Tofacitinib186,746Side effects
Adapalene181,062Side effects
Natalizumab180,844Side effects
Lorazepam178,731Side effects
Lansoprazole177,061
Cyclophosphamide176,005Side effects
Montelukast174,997Side effects
Cetirizine171,713
Methylprednisolone170,232Side effects
Diphenhydramine164,832Side effects
Evolocumab161,222Side effects
Tirzepatide160,663Side effects
Secukinumab160,421Side effects
Clonazepam159,283Side effects
Diclofenac158,675
Tacrolimus156,020Side effects
Allopurinol155,998Side effects
Hydroxychloroquine151,392Side effects

Source: FDA Adverse Event Reporting System via openFDA, through July 30, 2026

What next?

Most reported medicines
the analysis and its data