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Spironolactone Side Effects

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Common Spironolactone Side Effects


The most commonly reported Spironolactone side effects (click to view or check a box to report):

Hyperkalaemia (208)
Renal Failure Acute (103)
Dyspnoea (81)
Dehydration (59)
Asthenia (56)
Gynaecomastia (55)
Diarrhoea (52)
Nausea (50)
Blood Potassium Increased (50)
Blood Creatinine Increased (48)
Fatigue (46)
Hypotension (43)
Renal Failure (41)
Dizziness (40)
Pain (37)
Bradycardia (36)
Vomiting (33)
Hyponatraemia (33)
Oedema Peripheral (31)
Renal Impairment (28)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Spironolactone Side Effects Reported to FDA



Spironolactone Side Effect Report#9999397
Hyperkalaemia, Dehydration
This is a report of a 69-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Spironolactone (dosage: NA, start time:
Nov 15, 2010), combined with: NA. and developed a serious reaction and side effect(s): Hyperkalaemia, Dehydration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone treatment in male patients, resulting in Hyperkalaemia side effect.
Spironolactone Side Effect Report#9994717
Gynaecomastia
This report suggests a potential Spironolactone Gynaecomastia side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypertension and used Spironolactone (dosage: NA) starting
May 23, 2013. After starting Spironolactone the patient began experiencing various side effects, including: GynaecomastiaAdditional drugs used concurrently: NA. Although Spironolactone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gynaecomastia, may still occur.
Spironolactone Side Effect Report#9935370
Gynaecomastia
This Gynaecomastia problem was reported by a physician from US. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Spironolactone (dosage: Unk). The following drugs were being taken at the same time: NA. When using Spironolactone, the patient experienced the following unwanted symptoms/side effects: GynaecomastiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gynaecomastia, may become evident only after a product is in use by the general population.
Spironolactone Side Effect Report#9927737
Anxiety, Palpitations
This Anxiety side effect was reported by a physician from GB. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Spironolactone (drug dosage: 100 Mg, Qd), which was initiated on 201305. Concurrently used drugs: NA..After starting to take Spironolactone the consumer reported adverse symptoms, such as: Anxiety, PalpitationsThese side effects may potentially be related to Spironolactone.
Spironolactone Side Effect Report#9921747
Idiopathic Angioedema, Deformity, Mass, Loss Of Consciousness, Dehydration, Rhinitis Allergic, Flushing, Idiopathic Urticaria, Skin Discolouration
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: alopecia,off label use, who was treated with Spironolactone Tablets, Usp (dosage: NA, start time: 201307), combined with: NA. and developed a serious reaction and side effect(s): Idiopathic Angioedema, Deformity, Mass, Loss Of Consciousness, Dehydration, Rhinitis Allergic, Flushing, Idiopathic Urticaria, Skin Discolouration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone Tablets, Usp treatment in female patients, resulting in Idiopathic Angioedema side effect.
Spironolactone Side Effect Report#9910377
Anxiety, Palpitations, Off Label Use
This report suggests a potential Spironolactone Anxiety side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: acne and used Spironolactone (dosage: 100 Milligram Daily;) starting 201305. After starting Spironolactone the patient began experiencing various side effects, including: Anxiety, Palpitations, Off Label UseAdditional drugs used concurrently: NA. Although Spironolactone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Spironolactone Side Effect Report#9902314
Anxiety, Palpitations
This Anxiety problem was reported by a health professional from GB. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On 201305 this consumer started treatment with Spironolactone (dosage: 100 Mg, Once Daily). The following drugs were being taken at the same time: NA. When using Spironolactone, the patient experienced the following unwanted symptoms/side effects: Anxiety, PalpitationsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anxiety, may become evident only after a product is in use by the general population.
Spironolactone Side Effect Report#9888445
Deafness
This Deafness side effect was reported by a pharmacist from JP. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Spironolactone (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Spironolactone the consumer reported adverse symptoms, such as: DeafnessThese side effects may potentially be related to Spironolactone.
Spironolactone Side Effect Report#9887853
Hypotension, Bradycardia, Blood Potassium Increased
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Spironolactone (dosage: NA, start time:
Apr 15, 2008), combined with: NA. and developed a serious reaction and side effect(s): Hypotension, Bradycardia, Blood Potassium Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone treatment in male patients, resulting in Hypotension side effect. The patient was hospitalized.
Spironolactone Side Effect Report#9887497
Pain, Fatigue, Chills, Rhinorrhoea, Productive Cough, Vision Blurred, Renal Impairment, Dyspnoea Exertional
This report suggests a potential Spironolactone Pain side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cardiac failure congestive,hypertension,diabetes mellitus and used Spironolactone (dosage: NA) starting
Nov 30, 2003. After starting Spironolactone the patient began experiencing various side effects, including: Pain, Fatigue, Chills, Rhinorrhoea, Productive Cough, Vision Blurred, Renal Impairment, Dyspnoea ExertionalAdditional drugs used concurrently:
  • Lisinopril
  • Lisinopril
The patient was hospitalized. Although Spironolactone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Spironolactone Side Effect Report#9881124
Rash, Dyspnoea, Nervousness, Chest Discomfort, Nausea, Somnolence, Gastric Disorder, Malaise
This Rash problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: local swelling. On 201401 this consumer started treatment with Spironolactone (dosage: 0.5 Df, 1x/day). The following drugs were being taken at the same time: NA. When using Spironolactone, the patient experienced the following unwanted symptoms/side effects: Rash, Dyspnoea, Nervousness, Chest Discomfort, Nausea, Somnolence, Gastric Disorder, MalaiseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash, may become evident only after a product is in use by the general population.
Spironolactone Side Effect Report#9866868
Gout
This Gout side effect was reported by a consumer or non-health professional from US. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Spironolactone (drug dosage: Taken By Mouth), which was initiated on
Mar 10, 2009. Concurrently used drugs: NA..After starting to take Spironolactone the consumer reported adverse symptoms, such as: GoutThese side effects may potentially be related to Spironolactone.
Spironolactone Side Effect Report#9853540
Renal Failure Acute, Hypothyroidism
This is a report of a 45-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Spironolactone (dosage: 50 Mg, 1x/day, start time:
Jun 06, 2013), combined with:
  • Furosemide Biogaran (40 Mg, 1x/day)
  • Olanzapine (10 Mg, 1x/day)
  • Pantoprazole Biogaran (20 Mg, Daily)
  • Pantoprazole Biogaran (40 Mg, Daily)
  • Venlafaxine (37.5 Mg, 1x/day)
  • Levemir Flexpen (Twice Daily According To Blood Glucose Level)
  • Diamicron (60 Mg, 2x/day)
  • Lysanxia (10 Mg, As Needed)
and developed a serious reaction and side effect(s): Renal Failure Acute, Hypothyroidism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone treatment in female patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.
Spironolactone Side Effect Report#9849006
Renal Failure Acute, Malaise, Weight Increased, Urine Output Decreased, Musculoskeletal Pain, Dyspnoea, Vomiting, Acute Pulmonary Oedema
This report suggests a potential Spironolactone Renal Failure Acute side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: cardiac failure,fluid retention,myocardial infarction,myocardial ischaemia and used Spironolactone (dosage: 25 Milligram Daily; 25mg 1x/day) starting NS. After starting Spironolactone the patient began experiencing various side effects, including: Renal Failure Acute, Malaise, Weight Increased, Urine Output Decreased, Musculoskeletal Pain, Dyspnoea, Vomiting, Acute Pulmonary OedemaAdditional drugs used concurrently:
  • Furosemide (160 Milligram Daily; 80mg 2x/day)
  • Inspra (25 Milligram Daily; 25mg 1x/day)
  • Bisoprolol (7.5 Milligram Daily; 7.5mg 1x/day)
  • Bisoprolol
  • Losartan (25 Milligram Daily; 25mg 1x/day)
  • Losartan
  • Ivabradine (10 Milligram Daily; 5mg 2x/day)
  • Ivabradine
The patient was hospitalized. Although Spironolactone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Spironolactone Side Effect Report#9846520
Thrombocytopenia, White Blood Cell Count Decreased
This Thrombocytopenia problem was reported by a consumer or non-health professional from FR. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 10, 2012 this consumer started treatment with Spironolactone-altizide (dosage: 1 Df, Daily). The following drugs were being taken at the same time: NA. When using Spironolactone-altizide, the patient experienced the following unwanted symptoms/side effects: Thrombocytopenia, White Blood Cell Count DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombocytopenia, may become evident only after a product is in use by the general population.
Spironolactone Side Effect Report#9845553
Fatigue
This Fatigue side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Spironolactone (drug dosage: Unk), which was initiated on 201309. Concurrently used drugs:
  • Tirosint (50 Ug, Unk)
.After starting to take Spironolactone the consumer reported adverse symptoms, such as: FatigueThese side effects may potentially be related to Spironolactone.
Spironolactone Side Effect Report#9842716
Diabetes Mellitus, Gynaecomastia, Hormone Level Abnormal, Cardiac Discomfort, Abdominal Pain Upper, Nipple Pain
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cardiac disorder, who was treated with Spironolactone (dosage: Unk, 1x/day, start time: 2004), combined with:
  • Trazodone (Unk)
  • Paxil (Unk)
  • Novolog (Unk)
  • Levemir (Unk)
  • Vitamin D (Unk)
  • Magnesium (Unk)
  • Aspirin (Unk)
  • Micardis Hct (Unk)
and developed a serious reaction and side effect(s): Diabetes Mellitus, Gynaecomastia, Hormone Level Abnormal, Cardiac Discomfort, Abdominal Pain Upper, Nipple Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone treatment in male patients, resulting in Diabetes Mellitus side effect.
Spironolactone Side Effect Report#9818278
Hyponatraemia, Delirium
This report suggests a potential Spironolactone Hyponatraemia side effect(s) that can have serious consequences. A 89-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: cardiac failure chronic and used Spironolactone (dosage: Unk) starting NS. After starting Spironolactone the patient began experiencing various side effects, including: Hyponatraemia, DeliriumAdditional drugs used concurrently:
  • Furosemide
The patient was hospitalized. Although Spironolactone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.
Spironolactone Side Effect Report#9803048
Malaise, Fatigue, Asthenia, Heart Rate Irregular, Abdominal Pain, Gingival Bleeding, Oropharyngeal Pain, Pharyngeal Oedema, Swelling Face
This Malaise problem was reported by a consumer or non-health professional from US. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cardiac failure congestive. On
Dec 04, 2013 this consumer started treatment with Spironolactone (dosage: 1 Pill, Daily, Mouth). The following drugs were being taken at the same time:
  • Alprazolam
  • Amitriptyline
  • Atorvastatin
  • Benicar
  • B12
  • Diphenoxylate
  • Folic Acid
  • Omeprazole
When using Spironolactone, the patient experienced the following unwanted symptoms/side effects: Malaise, Fatigue, Asthenia, Heart Rate Irregular, Abdominal Pain, Gingival Bleeding, Oropharyngeal Pain, Pharyngeal Oedema, Swelling FaceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malaise, may become evident only after a product is in use by the general population.
Spironolactone Side Effect Report#9793099
Renal Failure Acute, Dehydration, Muscle Spasms, Abdominal Pain
This Renal Failure Acute side effect was reported by a pharmacist from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Spironolactone (drug dosage: NA), which was initiated on
Oct 16, 2013. Concurrently used drugs:
  • Lisinopril
.After starting to take Spironolactone the consumer reported adverse symptoms, such as: Renal Failure Acute, Dehydration, Muscle Spasms, Abdominal PainThese side effects may potentially be related to Spironolactone. The patient was hospitalized.
Spironolactone Side Effect Report#9778583
Blood Potassium Increased, Electrocardiogram T Wave Peaked, Chest Pain, Hyperhidrosis, Tachycardia, Dyspnoea
This is a report of a 89-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cardiac failure congestive, who was treated with Spironolactone (dosage: NA, start time:
Mar 05, 2013), combined with: NA. and developed a serious reaction and side effect(s): Blood Potassium Increased, Electrocardiogram T Wave Peaked, Chest Pain, Hyperhidrosis, Tachycardia, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone treatment in male patients, resulting in Blood Potassium Increased side effect. The patient was hospitalized.
Spironolactone Side Effect Report#9772759
Hyperkalaemia
This report suggests a potential Spironolactone Hyperkalaemia side effect(s) that can have serious consequences. A 85-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cardiac failure congestive,hypertension and used Spironolactone (dosage: NA) starting
Jun 26, 2007. After starting Spironolactone the patient began experiencing various side effects, including: HyperkalaemiaAdditional drugs used concurrently:
  • Lisinopril
The patient was hospitalized. Although Spironolactone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperkalaemia, may still occur.
Spironolactone Side Effect Report#9742337
Hypersensitivity
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2010 this consumer started treatment with Spironolactone Tablets 50mg (dosage: 50 Mg). The following drugs were being taken at the same time: NA. When using Spironolactone Tablets 50mg, the patient experienced the following unwanted symptoms/side effects: HypersensitivityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Spironolactone Side Effect Report#9742330
Breast Swelling, Breast Pain
This Breast Swelling side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood pressure increased.The patient was prescribed Spironolactone (drug dosage: 12.5 Mg), which was initiated on NS. Concurrently used drugs: NA..After starting to take Spironolactone the consumer reported adverse symptoms, such as: Breast Swelling, Breast PainThese side effects may potentially be related to Spironolactone.
Spironolactone Side Effect Report#9742329
Back Pain, Limb Discomfort, Pain, Feeling Cold, Fatigue
This is a report of a 76-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: oedema peripheral,blood pressure increased, who was treated with Spironolactone (dosage: NA, start time:
Jan 22, 2012), combined with: NA. and developed a serious reaction and side effect(s): Back Pain, Limb Discomfort, Pain, Feeling Cold, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spironolactone treatment in female patients, resulting in Back Pain side effect.


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The appearance of Spironolactone on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Spironolactone Side Effects for Women?

Women Side EffectsReports
Hyperkalaemia 49
Dyspnoea 39
Nausea 37
Renal Failure Acute 37
Dehydration 35
Diarrhoea 30
Pain 28
Asthenia 25
Fatigue 23
Blood Potassium Increased 22

What are common Spironolactone Side Effects for Men?

Men Side EffectsReports
Hyperkalaemia 152
Renal Failure Acute 65
Gynaecomastia 53
Dyspnoea 42
Blood Creatinine Increased 31
Hypotension 31
Asthenia 28
Blood Potassium Increased 27
Bradycardia 26
Dizziness 24

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Spironolactone reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Spironolactone Safety Alerts, Active Ingredients, Usage Information

    NDC0228-2672
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSpironolactone
    NameSpironolactone
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20070103
    LabelerActavis Elizabeth LLC
    Active Ingredient(s)SPIRONOLACTONE
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]

    Spironolactone Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1189

    Spironolactone safety alerts: No

    Reported deaths: 98

    Reported hospitalizations: 639

    Latest Spironolactone clinical trials