Macitentan

Common brands: Opsumit, Adcirca, Remodulin, Sildenafil, Sildenafil Citrate

Top reporter: Actelion Pharmaceuticals Us, Inc.

Endothelin Receptor Antagonist [EPC]Prostacycline Vasodilator [EPC]Phosphodiesterase 5 Inhibitor [EPC]Loop Diuretic [EPC]Prostacyclin Receptor Agonist [EPC]
67,845
Total Reports
36,437
Serious Reports
12,469
Death Reports
30
Reported Reactions
Death Report Ratio: High (18.38%)

Patient Demographics

Male
16,207
Female
49,366

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Macitentan.

# Reaction Reports % of Total
1 DYSPNOEA 11,817
10.3%
2 HEADACHE 8,182
7.2%
3 DEATH 7,329
6.4%
4 DIARRHOEA 6,487
5.7%
5 NAUSEA 5,889
5.1%
6 FATIGUE 4,963
4.3%
7 PNEUMONIA 4,510
3.9%
8 DIZZINESS 4,457
3.9%
9 HOSPITALISATION 4,079
3.6%
10 COUGH 3,862
3.4%
11 FLUID RETENTION 3,808
3.3%
12 MALAISE 3,571
3.1%
13 HYPOTENSION 3,562
3.1%
14 PULMONARY ARTERIAL HYPERTENSION 3,274
2.9%
15 VOMITING 3,154
2.8%
16 PAIN 2,727
2.4%
17 PAIN IN EXTREMITY 2,643
2.3%
18 CONDITION AGGRAVATED 2,614
2.3%
19 PERIPHERAL SWELLING 2,598
2.3%
20 OEDEMA PERIPHERAL 2,586
2.3%
21 DYSPNOEA EXERTIONAL 2,516
2.2%
22 OXYGEN SATURATION DECREASED 2,482
2.2%
23 CHEST PAIN 2,454
2.1%
24 ASTHENIA 2,443
2.1%
25 FALL 2,215
1.9%
26 PAIN IN JAW 2,179
1.9%
27 ANAEMIA 2,049
1.8%
28 PULMONARY HYPERTENSION 2,022
1.8%
29 NASAL CONGESTION 1,982
1.7%
30 DECREASED APPETITE 1,969
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.