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Soleton Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Fall, Dizziness (8027991-4)
on Jan 05, 2012 Male from KOREA, REPUBLIC OF , weighting 143.7 lb, was diagnosed with
  • pain
  • peptic ulcer
and was treated with Soleton. Directly after, patient experienced the unwanted or unexpected Soleton side effects: fall, dizziness. Soleton dosage: One Tablet Once A Day.
Associated medications used:
  • Mucosta (2 Tablets)
  • Paramacet (One Tablet Twice A Day)
  • Lidocaine (1 Vial)
  • Lyrica (1 Capsule Once A Day)
  • Ultracet (Decreased Dose To Half)
  • Ultracet (Two Tablets Twice A Day.)
  • Afloqualone (2 Tablets)
  • Triamcinolone Diacetate (1 Vial)
Patient was hospitalized.

Pneumonia, Pneumothorax, Hepatic Failure (7754625-6)
Patient was taking Soleton. Patient felt the following Soleton side effects: pneumonia, pneumothorax, hepatic failure on Aug 31, 2011 from JAPAN Additional patient health information: Male , 74 years of age, weighting 83.78 lb, . Soleton dosage: As Needed.
Multiple prescriptions taken:
  • Neurotropin (Unk)
  • Local Anesthetics
  • Calcichew D3 (Unk)
  • Digestives, Incl Enzymes (As Needed)
  • Tranexamic Acid
  • Montelukast Sodium
  • Contrast Media (Unk)
  • Dextromethorphan Hydrobromide (Unk)
Patient was hospitalized.

Pharyngeal Ulceration (7213756-X)
Adverse event was reported on Dec 28, 2010 by a Male taking Soleton (Dosage: Unk) . Location: JAPAN , 73 years of age, After Soleton was administered, patient encountered several Soleton side effects: pharyngeal ulceration.
Multiple concurrent drugs taken:
  • Mucosta (Unk)
  • Lyrica (150 Mg Daily)
  • Neurotropin (Unk)
Patient was hospitalized.

Haematocrit Decreased, Haemoglobin Decreased, Inflammation, Melaena, Platelet Count Decreased, Rectal Ulcer, Red Blood Cell Count Decreased (5156072-2)
on Oct 11, 2006 Female from JAPAN , 76 years of age, was diagnosed with
  • pain
  • postoperative infection
and was treated with Soleton. Directly after, patient experienced the unwanted or unexpected Soleton side effects: haematocrit decreased, haemoglobin decreased, inflammation, melaena, platelet count decreased, rectal ulcer, red blood cell count decreased. Soleton dosage: 240 Mg/day.
Associated medications used:
  • Cefzon (300 Mg/day)
  • Levofloxacin (300 Mg/day)
  • Kamag G (1.5 G/day)
  • Voltaren (25 Mg/day)
  • Cefazolin Sodium (1 G/day)
  • Cefazolin Sodium (2 G/day)
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Soleton Information

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Side Effects reported to FDA: 4. View Soleton Adverse Reports

Soleton safety alerts: No

Reported deaths: 1

Reported hospitalizations: 4

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