MACITENTAN\TADALAFIL: 550 Adverse Event Reports & Safety Profile
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550
Total FAERS Reports
25 (4.5%)
Deaths Reported
136
Hospitalizations
550
As Primary/Secondary Suspect
3
Life-Threatening
First Report: 20030101 · Latest Report: 20250925
What Are the Most Common MACITENTAN\TADALAFIL Side Effects?
#1 Most Reported
Headache
75 reports (13.6%)
#2 Most Reported
Dyspnoea
56 reports (10.2%)
#3 Most Reported
Product dose omission issue
46 reports (8.4%)
All MACITENTAN\TADALAFIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 75 | 13.6% | 0 | 12 |
| Dyspnoea | 56 | 10.2% | 1 | 16 |
| Product dose omission issue | 46 | 8.4% | 0 | 3 |
| Hospitalisation | 42 | 7.6% | 3 | 40 |
| Dizziness | 32 | 5.8% | 0 | 10 |
| Death | 30 | 5.5% | 23 | 4 |
| Diarrhoea | 29 | 5.3% | 0 | 12 |
| Fatigue | 25 | 4.6% | 0 | 5 |
| Adverse drug reaction | 24 | 4.4% | 0 | 1 |
| Hypotension | 22 | 4.0% | 0 | 9 |
| Nausea | 21 | 3.8% | 0 | 9 |
| Fluid retention | 16 | 2.9% | 0 | 8 |
| Arthralgia | 15 | 2.7% | 0 | 6 |
| Swelling | 15 | 2.7% | 0 | 3 |
| Vomiting | 15 | 2.7% | 0 | 6 |
| Off label use | 14 | 2.6% | 0 | 1 |
| Pain in extremity | 14 | 2.6% | 0 | 6 |
| Peripheral swelling | 14 | 2.6% | 0 | 4 |
| Oedema | 13 | 2.4% | 0 | 2 |
| Drug intolerance | 12 | 2.2% | 0 | 0 |
Who Reports MACITENTAN\TADALAFIL Side Effects? Age & Gender Data
Gender: 76.1% female, 23.9% male. Average age: 56.8 years. Most reports from: US. View detailed demographics →
Is MACITENTAN\TADALAFIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2020 | 1 | 1 | 1 |
| 2022 | 2 | 0 | 2 |
| 2023 | 1 | 0 | 1 |
| 2024 | 69 | 4 | 32 |
| 2025 | 94 | 2 | 24 |
What Is MACITENTAN\TADALAFIL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 380 |
| Pulmonary arterial hypertension | 135 |
| Pulmonary hypertension | 7 |
MACITENTAN\TADALAFIL vs Alternatives: Which Is Safer?
MACITENTAN\TADALAFIL vs MAGNESIUM
MACITENTAN\TADALAFIL vs MAGNESIUM ASPARTATE
MACITENTAN\TADALAFIL vs MAGNESIUM ASPARTATE\POTASSIUM ASPARTATE
MACITENTAN\TADALAFIL vs MAGNESIUM HYDROXIDE
MACITENTAN\TADALAFIL vs MAGNESIUM OROTATE
MACITENTAN\TADALAFIL vs MAGNESIUM SALICYLATE
MACITENTAN\TADALAFIL vs MAGNESIUM\MAGNESIUM HEPTAHYDRATE
MACITENTAN\TADALAFIL vs MAGNESIUM\POTASSIUM\SODIUM
MACITENTAN\TADALAFIL vs MAGNESIUM\PYRIDOXINE
MACITENTAN\TADALAFIL vs MAGNEVIST
Official FDA Label for MACITENTAN\TADALAFIL
Official prescribing information from the FDA-approved drug label.