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Midamor (Amiloride Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

MIDAMOR is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq per liter — see WARNINGS), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride are generally those known to be associated with diuresis, or with the underlying disease being treated.

The adverse reactions for MIDAMOR listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with MIDAMOR). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between MIDAMOR and these adverse reactions, some of which have been reported only rarely.

Incidence >1% Incidence ≤1%
Body as a Whole
  Headache 1
  Weakness
  Fatigability
  Back pain
  Chest pain
  Neck/shoulder ache
  Pain, extremities
Cardiovascular
  None  Angina pectoris
  Orthostatic hypotension
  Arrhythmia
  Palpitation
Digestive
  Nausea/anorexia
  Diarrhea
  Vomiting
  Abdominal pain
  Gas pain
  Appetite changes
  Constipation
  Jaundice
  GI bleeding
  Abdominal fullness
  GI disturbance
  Thirst
  Heartburn
  Flatulence
  Dyspepsia
Metabolic
  Elevated serum
  potassium levels
  (>5.5 mEq per liter)See WARNINGS.
  None
Skin
  None  Skin rash
  Itching
  Dryness of mouth
  Pruritus
  Alopecia
Musculoskeletal
  Muscle cramps  Joint pain
  Leg ache
Nervous
  Dizziness
  Encephalopathy
  Paresthesia
  Tremors
  Vertigo
Psychiatric
  None  Nervousness
  Mental confusion
  Insomnia
  Decreased libido
  Depression
  Somnolence
Respiratory
  Cough
  Dyspnea
  Shortness of breath
Special Senses
  None  Visual disturbances
  Nasal congestion
  Tinnitus
  Increased intraocular pressure
Urogenital
  Impotence  Polyuria
  Dysuria
  Urinary frequency
  Bladder spasms
  Gynecomastia

1 Reactions occurring in 3% to 8% of patients treated with MIDAMOR. (Those reactions occurring in less than 3% of the patients are unmarked.)

Causal Relationship Unknown

Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

  •  Activation of probable pre-existing peptic ulcer
  •  Aplastic anemia
  •  Neutropenia
  •  Abnormal liver function


REPORTS OF SUSPECTED MIDAMOR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Midamor. The information is not vetted and should not be considered as verified clinical evidence.

Possible Midamor side effects / adverse reactions in 72 year old female

Reported by a physician from Netherlands on 2011-11-14

Patient: 72 year old female

Reactions: Depressed Level of Consciousness, Hyponatraemia, Fall

Adverse event resulted in: hospitalization

Suspect drug(s):
Hydrochlorothiazide
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Midamor
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



See index of all Midamor side effect reports >>

Drug label data at the top of this Page last updated: 2008-10-16

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