Table 1.
Most frequently reported MedDRA preferred terms
| Event preferred terms | Total cases |
|---|---|
| Gastrointestinal disorders | |
| Diarrhea | 19 |
| Vomiting | 15 |
| Nausea | 11 |
| Abdominal pain | 8 |
| Allergic reactions | |
| Urticaria | 14 |
| Hypersensitivity | 7 |
| Pruritus | 7 |
| Anaphylactic reaction | 6 |
| Dermatitis allergic | 4 |
| Cardiac, Vascular, Respiratory, and General disorders | |
| Dyspnea | 12 |
| Dizziness | 8 |
| Fatigue | 7 |
| Malaise | 7 |
| Hypotension | 6 |
| Respiratory failure | 5 |
| Pyrexia | 5 |
| Palpitations | 4 |
| Bone marrow toxicity | |
| Aplastic anemiaa | 5 |
| Platelet count decreased | 4 |
| White blood cell count decreased | 4 |
| Nervous system-related disorders | |
| Headache | 5 |
| Loss of consciousness | 5 |
| Others | |
| Maternal drugs affecting fetus | 7 |
| Hepatitis | 5 |
| Renal failure | 4 |
Preferred terms included in 146 FAERS reports; a report may contain more than one preferred term; PTs are grouped by the authors
PT preferred terms, MedDRA Medical Dictionary for Regulatory Activities, FAERS Food and Drug Administration Adverse Event Reporting System
aSubsequent review of the reports revealed that one case met criteria for aplastic anemia