Applies to finasteride / tadalafil: oral capsule.
Serious side effects
Along with its needed effects, finasteride/tadalafil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking finasteride / tadalafil:
More common
- Chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
Less common
- Arm, back, or jaw pain
- bloody urine
- blurred vision
- burning, dry, or itching eyes
- chest pain, discomfort, tightness, or heaviness
- continuing ringing or buzzing or other unexplained noise the in ears
- decreased amount of urine
- discharge, excessive tearing
- eye pain
- fainting
- fast, pounding, or irregular heartbeat or pulse
- hearing loss
- increased blood pressure
- increased thirst
- loss of appetite
- lower back or side pain
- nausea
- redness, pain, or swelling of the eye, eyelid, or inner lining the of eyelid
- sweating
- swelling of the face, hands, fingers, ankles, feet, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting
- weight gain
Incidence not known
- Blindness
- blistering, peeling, or loosening of the skin
- change in vision
- clear or bloody discharge from nipple
- cough
- decreased vision
- dimpling of the breast skin
- fever
- hives, itching, skin rash
- inverted nipple
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lump in the breast or under the arm
- painful or prolonged erection of the penis
- persistent crusting or scaling of the nipple
- red irritated eyes
- red skin lesions, often with a purple center
- redness of the skin
- redness or swelling of the breast
- sore on the skin of the breast that does not heal
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
Other side effects
Some side effects of finasteride / tadalafil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Change or problem with discharge of semen
- decreased interest in sexual intercourse
- inability to have or keep an erection
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
Less common
- Acid or sour stomach
- belching
- bleeding from the rectum or bloody stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning feeling in the chest or stomach
- difficulty in moving
- difficulty swallowing
- dry mouth
- feeling of constant movement of self or surroundings
- headache
- heartburn
- indigestion
- muscle aches, cramps, pains, or stiffness
- pain in the arms or legs
- pain or burning in the throat
- sensation of spinning
- sleepiness or unusual drowsiness
- sneezing
- stomach upset
- stuffy or runny nose
- swelling of the breasts or breast soreness in both females and males
- swollen joints
Rare
- Breast enlargement
Incidence not known
- Discouragement
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- tiredness
- trouble concentrating
For Healthcare Professionals
Applies to finasteride / tadalafil: oral capsule.
Cardiovascular
Common (1% to 10%):
-Finasteride: Hypotension, postural hypotension
Frequency not reported:
-Tadalafil: Angina pectoris, chest pain, hypotension, myocardial infarction, palpitations, postural hypotension, syncope, tachycardia
Postmarketing reports:
-Tadalafil: Stroke, sudden cardiac death[Ref]
Dermatologic
Uncommon (0.1% to 1%):
-Finasteride: Rash
-Tadalafil: Pruritus, rash, sweating
Postmarketing reports:
-Finasteride: Angioedema (including swelling of the lips, tongue, throat, and face), pruritus, urticaria
-Tadalafil: Exfoliative dermatitis, Stevens-Johnson syndrome, urticaria[Ref]
Gastrointestinal
Common (1% to 10%):
-Tadalafil: Dyspepsia, diarrhea
Frequency not reported:
-Tadalafil: Abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux disease, GGTP increased, hemorrhoidal hemorrhage, loose stools, nausea, rectal hemorrhage, upper abdominal pain, vomiting[Ref]
General
The most frequently reported adverse reactions in studies evaluating finasteride in monotherapy or in combination therapy were related to sexual function.[Ref]
Genitourinary
Common (1% to 10%):
-Finasteride: Abnormal ejaculation, decreased volume of ejaculate
Frequency not reported:
-Tadalafil: Erection increased, spontaneous penile erection
Postmarketing reports:
-Finasteride: Testicular pain
-Tadalafil: Priapism[Ref]
Musculoskeletal
Common (1% to 10%):
-Tadalafil: Back pain, myalgia, pain in extremity
Frequency not reported:
-Tadalafil: Arthralgia, muscle spasm, neck pain[Ref]
Ocular
Frequency not reported:
-Tadalafil: Blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, increased lacrimation, swelling of eyelids
Postmarketing reports:
-Tadalafil: Non-arteritic anterior ischemic optic neuropathy (NAION), retinal artery occlusion, retinal vein occlusion, visual field defect[Ref]
Other
Common (1% to 10%):
-Finasteride: Abnormal sexual function, asthenia, breast enlargement, decreased libido, gynecomastia, impotence, peripheral edema
Uncommon (0.1% to 1%):
-Finasteride: Breast tenderness
Frequency not reported:
-Tadalafil: Asthenia, face edema, fatigue, pain, peripheral edema, sudden decrease or loss of hearing, tinnitus
Postmarketing reports:
-Finasteride: Decreased libido and ejaculation disorders (e.g. reduced ejaculate volume),
hematospermia, male breast cancer, male infertility and/or poor seminal quality, sexual dysfunction that continued after discontinuation of treatment including erectile dysfunction
-Tadalafil: Sudden decrease or loss of hearing[Ref]
Renal
Frequency not reported:
-Tadalafil: Renal impairment[Ref]
Respiratory
Common (1% to 10%):
-Tadalafil: Nasopharyngitis
Uncommon (0.1% to 1%):
-Finasteride: Dyspnea, rhinitis
Frequency not reported:
-Tadalafil: Dyspnea, epistaxis, pharyngitis[Ref]
Nervous system
Common (1% to 10%):
-Finasteride: Dizziness, headache, somnolence
-Tadalafil: Dizziness, headache
Frequency not reported:
-Tadalafil: Hypesthesia, insomnia, paresthesia, somnolence, vertigo
Postmarketing reports:
-Finasteride: Depression
-Tadalafil: Migraine, seizure and seizure recurrence, transient global amnesia[Ref]
