Invokana Side Effects

Generic Name: canagliflozin

Note: This page contains information about the side effects of canagliflozin. Some of the dosage forms included on this document may not apply to the brand name Invokana.

Not all side effects for Invokana may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to canagliflozin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by canagliflozin (the active ingredient contained in Invokana). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking canagliflozin:

More common
  • Bladder pain
  • bloody or cloudy urine
  • decreased frequency or amount of urine
  • difficult, burning, or painful urination
  • discharge with a strong odor from the penis
  • frequent urge to urinate
  • increased blood pressure
  • increased thirst
  • itching of the vagina or outside of the genitals
  • loss of appetite
  • lower back or side pain
  • nausea
  • pain during sexual intercourse
  • pain in the skin around the penis
  • redness, itching, or swelling of the penis
  • swelling of the face, fingers, or lower legs
  • troubled breathing
  • unusual tiredness or weakness
  • vaginal discharge without odor or with mild odor
  • vomiting
  • weight gain
Less common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • dry mouth
  • fast or irregular heartbeat
  • headache
  • hives or welts
  • increased hunger
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nightmares
  • rash
  • redness of the skin
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • numbness or tingling in the hands, feet, or lips
  • sweating
  • weakness or heaviness of the legs

Some of the side effects that can occur with canagliflozin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Difficulty having a bowel movement (stool)
  • lack or loss of strength
  • pain or swelling in the arms or legs without an injury
Rare
  • Increased sensitivity of the skin to sunlight
  • redness or other discoloration of the skin
  • severe sunburn

For Healthcare Professionals

Applies to canagliflozin: oral tablet

General

The most commonly reported adverse reactions were hypoglycemia when used in combination with insulin or an insulin secretagogue, vulvovaginal candidiasis, urinary tract infection, and increased urinary frequency.

Genitourinary

Very common (10% or more): Female genital mycotic infections including vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal (up to 11.4%), recurrent male genital mycotic infections (22%)
Common (1% to 10%): Urinary tract infection, increased urination, male genital mycotic infections including balanitis, balanoposthitis, balanitis candida, and fungal genital infection
Uncommon (0.1% to 1%): Phimosis

Cardiovascular

Common (1% to 10%): Adverse reactions related to reduced intravascular volume (postural hypotension, orthostatic hypotension, hypotension, dehydration, and syncope)

Metabolic

Very common (10% or more): Hypoglycemia when combined with insulin or an insulin secretagogue (up to 49%), hyperkalemia (up to 27%)
Common (1% to 10%): Increased serum magnesium, increased serum phosphate, increased low-density lipoprotein (LDL-C)

Gastrointestinal

Common (1% to 10%): Constipation, thirst, nausea, abdominal pain, pancreatitis

Musculoskeletal

In a pooled analysis of 8 clinical trials with a mean duration drug exposure of 68 weeks, the rate of bone fracture was 18.7 and 17.6 per 1000 patient years of exposure to the 100 or 300 mg dose, respectively compared with 14.2 in those receiving comparator drug or placebo. Upper extremity fractures were more common in the canagliflozin (the active ingredient contained in Invokana) exposed group.

Uncommon (0.1% to 1%): Bone fracture, upper extremity fracture

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema
Frequency not reported: Serious hypersensitivity reaction

Renal

In a pooled analysis among patients with moderate renal impairment, the incidence of renal related adverse reactions such as increased serum creatinine, decreased eGFR, renal impairment, or acute renal failure, was 8.9% and 9.3% in patients receiving canagliflozin (the active ingredient contained in Invokana) 100 mg or 300 mg, compared with 3.7% in those receiving comparator drug or placebo.

Frequency not reported: Increases in serum creatinine, decreases in eGFR, renal impairment, acute renal failure

Dermatologic

Uncommon (0.1% to 1%): Photosensitivity reactions, rash, urticaria

Other

Common (1% to 10%): Fatigue, asthenia

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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