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
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 |
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
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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
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