Table 2.
MedDRA Preferred Terms | Subcategory Prevalence |
---|---|
Anxiety | 16.4% (95% CI: 12.8–20.6) |
Cough | 15.5% (95% CI: 11.6–19.4) |
Paranoia | 9.3% (95% CI: 6.3–12.2) |
Accidental overdose | 8.7% (95% CI: 5.7–11.9) |
Heart rate increased | 6.9% (95% CI: 4.5–9.9) |
Panic attack | 6.9% (95% CI: 4.2–9.6) |
Dyspnoea | 5.7% (95% CI: 3.3–8.4) |
Headache | 5.4% (95% CI: 3.0–7.8) |
Nausea | 5.4% (95% CI: 3.0–7.8) |
Vomiting | 5.4% (95% CI: 3.0–7.8) |
Dizziness | 5.1% (95% CI: 3.0–7.5) |
Feeling abnormal | 4.8% (95% CI: 2.7–7.2) |
Throat irritationa | 4.2% (95% CI: 2.1–6.6) |
Pulmonary paina | 3.9% (95% CI: 2.1–6.0) |
Chest pain | 3.6% (95% CI: 1.8–5.7) |
Amnesia | 3.3% (95% CI: 1.5–5.4) |
Chest discomfort | 3.0% (95% CI: 1.5–5.1) |
Fatigue | 3.0% (95% CI: 1.2–4.8) |
Tremor | 3.0% (95% CI: 1.2–4.8) |
Depression | 2.7% (95% CI: 0.9–4.5) |
Panic reaction | 2.7% (95% CI: 1.2–4.5) |
Withdrawal syndrome | 2.7% (95% CI: 1.2–4.5) |
Disturbance in attention | 2.4% (95% CI: 0.9–4.2) |
Unevaluable event | 2.4% (95% CI: 0.9–4.2) |
Abnormal dreams | 2.1% (95% CI: 0.6–3.6) |
Insomnia | 2.1% (95% CI: 0.6–3.9) |
Decreased appetite | 1.8% (95% CI: 0.6–3.3) |
Hypoaesthesia | 1.8% (95% CI: 0.6–3.3) |
Chills | 1.8% (95% CI: 0.6–3.3) |
Depersonalisation/derealisation disorder | 1.8% (95% CI: 0.6–3.3) |
Somnolence | 1.8% (95% CI: 0.6–3.3) |
Dry mouth | 1.8% (95% CI: 0.6–3.3) |
Metamorphopsiaa | 1.8% (95% CI: 0.6–3.6) |
Dependencea | 1.5% (95% CI: 0.3–3.0) |
Increased appetitea | 1.5% (95% CI: 0.3–3.0) |
Diarrhoea | 1.5% (95% CI: 0.3–3.0) |
Head discomforta | 1.5% (95% CI: 0.3–3.0) |
Respiratory tract irritation | 1.5% (95% CI: 0.3–3.0) |
Productive cougha | 1.5% (95% CI: 0.3–3.0) |
Oropharyngeal pain | 1.5% (95% CI: 0.3–2.7) |
Abdominal pain upper | 1.5% (95% CI: 0.3–2.7) |
Abdominal discomfort | 1.5% (95% CI: 0.3–3.0) |
Hyperhidrosis | 1.5% (95% CI: 0.3–3.0) |
Muscle twitching | 1.5% (95% CI: 0.3–3.0) |
Time perception altered | 1.5% (95% CI: 0.3–3.0) |
Vision blurred | 1.2% (95% CI: 0.3–2.4) |
Drug withdrawal syndrome | 1.2% (95% CI: 0.3–2.7) |
Dysarthria | 1.2% (95% CI: 0.3–2.4) |
Hallucination, visual | 1.2% (95% CI: 0.3–2.4) |
Autoscopya | 1.2% (95% CI: 0.3–2.7) |
Abdominal pain | 0.9% (95% CI: 0.0–2.1) |
Hallucinations, mixed | 0.9% (95% CI: 0.0–2.1) |
Loss of consciousness | 0.9% (95% CI: 0.0–1.8) |
Hypertension | 0.9% (95% CI: 0.0–2.1) |
Ocular hyperaemia | 0.9% (95% CI: 0.0–2.1) |
Seizure | 0.9% (95% CI: 0.0–2.1) |
Disorientation | 0.9% (95% CI: 0.0–1.8) |
Dissociation | 0.9% (95% CI: 0.0–1.8) |
Irritability | 0.9% (95% CI: 0.0–2.1) |
Muscle spasms | 0.9% (95% CI: 0.0–2.1) |
Paraesthesia | 0.9% (95% CI: 0.0–2.1) |
Tinnitus | 0.9% (95% CI: 0.0–2.1) |
Sedation | 0.9% (95% CI: 0.0–2.1) |
Sneezinga | 0.9% (95% CI: 0.0–2.1) |
Vertigo | 0.9% (95% CI: 0.0–2.1) |
Pain | 0.6% (95% CI: 0.0–1.5) |
Agitation | 0.6% (95% CI: 0.0–1.5) |
Choking sensation | 0.6% (95% CI: 0.0–1.5) |
Delusion | 0.6% (95% CI: 0.0–1.5) |
Depressed mooda | 0.6% (95% CI: 0.0–1.5) |
Blood pressure increased | 0.6% (95% CI: 0.0–1.5) |
Thirst | 0.6% (95% CI: 0.0–1.5) |
Flatulencea | 0.6% (95% CI: 0.0–1.5) |
Hunger | 0.6% (95% CI: 0.0–1.5) |
Nervousness | 0.6% (95% CI: 0.0–1.5) |
Palpitations | 0.6% (95% CI: 0.0–1.5) |
Dysphemiaa | 0.6% (95% CI: 0.0–1.5) |
Bruxisma | 0.6% (95% CI: 0.0–1.5) |
Ill-defined disordera | 0.6% (95% CI: 0.0–1.5) |
Blepharospasma | 0.6% (95% CI: 0.0–1.5) |
Food cravinga | 0.6% (95% CI: 0.0–1.5) |
Presyncope | 0.6% (95% CI: 0.0–1.5) |
Tachyphrenia | 0.6% (95% CI: 0.0–1.5) |
Abnormal loss of weighta | 0.6% (95% CI: 0.0–1.5) |
Emotional povertya | 0.6% (95% CI: 0.0–1.5) |
Balance disorder | 0.6% (95% CI: 0.0–1.5) |
Sensory disturbance | 0.3% (95% CI: 0.0–0.9) |
Acnea | 0.3% (95% CI: 0.0–0.9) |
Hypersensitivity | 0.3% (95% CI: 0.0–0.9) |
Altered state of consciousness | 0.3% (95% CI: 0.0–0.9) |
Ammonia increaseda | 0.3% (95% CI: 0.0–0.9) |
Abdominal distensiona | 0.3% (95% CI: 0.0–1.2) |
Eye irritation | 0.3% (95% CI: 0.0–0.9) |
Tongue discomforta | 0.3% (95% CI: 0.0–0.9) |
Cold sweat | 0.3% (95% CI: 0.0–0.9) |
Constipation | 0.3% (95% CI: 0.0–0.9) |
Haemoptysisa | 0.3% (95% CI: 0.0–0.9) |
Formication | 0.3% (95% CI: 0.0–0.9) |
Dehydration | 0.3% (95% CI: 0.0–0.9) |
Non-24-h sleep–wake disordera | 0.3% (95% CI: 0.0–0.9) |
Dry eyea | 0.3% (95% CI: 0.0–0.9) |
Dry throata | 0.3% (95% CI: 0.0–0.9) |
Asthmaa | 0.3% (95% CI: 0.0–0.9) |
Burning sensation | 0.3% (95% CI: 0.0–0.9) |
Eye paina | 0.3% (95% CI: 0.0–0.9) |
Asthenopiaa | 0.3% (95% CI: 0.0–0.9) |
Fear | 0.3% (95% CI: 0.0–0.9) |
Feeling jittery | 0.3% (95% CI: 0.0–0.9) |
Feeling hot | 0.3% (95% CI: 0.0–0.9) |
Pyrexia | 0.3% (95% CI: 0.0–0.9) |
Photopsiaa | 0.3% (95% CI: 0.0–1.2) |
Hallucination | 0.3% (95% CI: 0.0–0.9) |
Hangovera | 0.3% (95% CI: 0.0–0.9) |
Hepatic encephalopathya | 0.3% (95% CI: 0.0–0.9) |
Urticaria | 0.3% (95% CI: 0.0–0.9) |
Psychomotor hyperactivity | 0.3% (95% CI: 0.0–0.9) |
Salivary hypersecretiona | 0.3% (95% CI: 0.0–0.9) |
Apathy | 0.3% (95% CI: 0.0–0.9) |
Hepatomegalya | 0.3% (95% CI: 0.0–0.9) |
Ageusiaa | 0.3% (95% CI: 0.0–0.9) |
Mood swings | 0.3% (95% CI: 0.0–0.9) |
Nasal discomforta | 0.3% (95% CI: 0.0–0.9) |
Rhinalgiaa | 0.3% (95% CI: 0.0–0.9) |
Neuralgiaa | 0.3% (95% CI: 0.0–1.2) |
Night sweats | 0.3% (95% CI: 0.0–0.9) |
Nightmarea | 0.3% (95% CI: 0.0–0.9) |
Epistaxis | 0.3% (95% CI: 0.0–0.9) |
Pain in extremitya | 0.3% (95% CI: 0.0–0.9) |
Painful respirationa | 0.3% (95% CI: 0.0–0.9) |
Illusion | 0.3% (95% CI: 0.0–0.9) |
Post-traumatic stress disorder | 0.3% (95% CI: 0.0–0.9) |
Eyelid ptosisa | 0.3% (95% CI: 0.0–1.2) |
Rhinorrhoeaa | 0.3% (95% CI: 0.0–0.9) |
Libido increaseda | 0.3% (95% CI: 0.0–0.9) |
Shock | 0.3% (95% CI: 0.0–0.9) |
Sinusitis | 0.3% (95% CI: 0.0–0.9) |
Sinus paina | 0.3% (95% CI: 0.0–0.9) |
Sleep attacksa | 0.3% (95% CI: 0.0–0.9) |
Poor quality sleep | 0.3% (95% CI: 0.0–0.9) |
Odynophagiaa | 0.3% (95% CI: 0.0–0.9) |
Swollen tongue | 0.3% (95% CI: 0.0–0.9) |
Pharyngeal swellinga | 0.3% (95% CI: 0.0–0.9) |
Throat tightness | 0.3% (95% CI: 0.0–0.9) |
Vascular paina | 0.3% (95% CI: 0.0–0.9) |
Visual impairment | 0.3% (95% CI: 0.0–0.9) |
Weight increaseda | 0.3% (95% CI: 0.0–0.9) |
Piloerectiona | 0.3% (95% CI: 0.0–0.9) |
Energy increaseda | 0.3% (95% CI: 0.0–0.9) |
Thirst decreaseda | 0.3% (95% CI: 0.0–0.9) |
Lazinessa | 0.3% (95% CI: 0.0–0.9) |
Perihepatic discomforta | 0.3% (95% CI: 0.0–0.9) |
Derealisationa | 0.3% (95% CI: 0.0–0.9) |
Negative thoughts | 0.3% (95% CI: 0.0–0.9) |
Rash | 0.3% (95% CI: 0.0–1.2) |
Tooth deposita | 0.3% (95% CI: 0.0–0.9) |
Neurological symptoma | 0.3% (95% CI: 0.0–0.9) |
Photophobiaa | 0.3% (95% CI: 0.0–0.9) |
Intra-abdominal fluid collectiona | 0.3% (95% CI: 0.0–0.9) |
Gastrooesophageal reflux disease | 0.3% (95% CI: 0.0–1.2) |
Paralysis | 0.3% (95% CI: 0.0–0.9) |
Hyperacusisa | 0.3% (95% CI: 0.0–1.2) |
Secretion dischargea | 0.3% (95% CI: 0.0–0.9) |
Appetite disordera | 0.3% (95% CI: 0.0–0.9) |
Sputum discoloureda | 0.3% (95% CI: 0.0–0.9) |
Urinary retentiona | 0.3% (95% CI: 0.0–0.9) |
Pneumonitisa | 0.3% (95% CI: 0.0–0.9) |
Oropharyngeal discomforta | 0.3% (95% CI: 0.0–0.9) |
Rash erythematousa | 0.3% (95% CI: 0.0–1.2) |
Axillary paina | 0.3% (95% CI: 0.0–0.9) |
aIndicates a MedDRA preferred term that was not listed in a FAERS case
Abbreviations: FAERS Food and Drug Administration Adverse Event Reporting System, MedDRA Medical Dictionary for Regulatory Activities