Rapiflux Side Effects
Generic name: fluoxetine
Medically reviewed by Drugs.com. Last updated on Feb 7, 2022.
Note: This document contains side effect information about fluoxetine. Some of the dosage forms listed on this page may not apply to the brand name Rapiflux.
For the Consumer
Applies to fluoxetine: oral capsules conventional and delayed-release, oral solution, oral tablets
- Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 470 471 Fluoxetine is not approved for use in pediatric patients except for patients with major depressive disorder or obsessive-compulsive disorder.1 (See Pediatric Use under Cautions.)
- In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.1 470 471
- Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.1 470 471
- Appropriately monitor and closely observe all patients who are started on fluoxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 470 471 476 (See Worsening of Depression and Suicidality Risk under Cautions.)
Side effects include:
Anxiety, nervousness, insomnia, somnolence, asthenia, tremor, anorexia, nausea, dyspepsia, diarrhea, vasodilation, dry mouth, decreased libido, abnormal ejaculation, impotence, rash, sweating, abnormal dreams, flu syndrome, pharyngitis, sinusitis, yawning.
For Healthcare Professionals
Applies to fluoxetine: compounding powder, oral capsule, oral delayed release capsule, oral solution, oral tablet
Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin.[Ref]
Very common (10% or more): Headache (up to 21%), somnolence (up to 17%), tremor (up to 13%), dizziness (up to 11%)
Common (1% to 10%): Amnesia, hyperkinesia, paresthesia/sensory disturbances, taste perversion/dysgeusia
Uncommon (0.1% to 1%): Abnormal gait, acute brain syndrome, ataxia, balance disorder, central nervous system (CNS) depression, CNS stimulation, dyskinesia, hyperkinesia, hypertonia, hyperesthesia, incoordination, memory impairment, migraine, myoclonus, neuralgia, neuropathy, syncope, vascular headache, vertigo
Rare (0.01% to 0.1%): Abnormal electroencephalogram, cerebral embolism, cerebral ischemia, circumoral paresthesia, convulsion/seizures, delusions, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, parosmia, reflexed decreased, serotonin syndrome (neuroleptic malignant syndrome-like effects), stupor, taste loss
Very rare (less than 0.01%): Mild intensity headache
Frequency not reported: Autonomic instability, coma, hyperreflexia, hypersomnia, neuromuscular aberrations, sedation
Very common (10% or more): Insomnia (up to 33%), anxiety (up to 15%), nervousness (up to 14%)
Common (1% to 10%): Abnormal dreams, agitation, disturbance in attention, emotional lability, hostility, hypomania, mania, personality disorder, restlessness, sleep disorder, tension, thinking abnormal
Uncommon (0.1% to 1%): Akathisia, apathy, bruxism, depersonalization, elevated mood, euphoria, intentional overdose, manic reaction, neurosis, paranoid reaction, psychomotor hyperactivity, psychosis, suicidal thoughts and behavior, suicide attempt
Rare (less than 0.1%): Aggression, antisocial reaction, delusions, dysphemia, hallucinations, panic attacks
Frequency not reported: Activation syndrome, anger, complete suicide, depression, depression suicidal, early morning awakening, initial insomnia, intense dreams, intentional self-injury, mental status changes, middle insomnia, morbid thoughts, nightmares, self-injurious ideation and behavior, sleep disturbances, suicidal ideation
Postmarketing reports: Confusion, discontinuation/withdrawal symptoms, irritability, violent behaviors[Ref]
Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.
Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.[Ref]
A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRIs relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed in 3.9 times more frequently in patients receiving this drug.[Ref]
Very common (10% or more): Nausea (up to 29%), diarrhea (up to 18%), dry mouth (up to 12%)
Uncommon (0.1% to 1%): Aphthous stomatitis, buccoglossal syndrome, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal (GI) hemorrhage, glossitis, gum hemorrhage, hyperchlorhydria, increased salivation, melena, mouth ulceration, stomach ulcer, stomatitis
Rare (less than 0.1%): Acute abdominal syndrome, bloody diarrhea, duodenal ulcer, enteritis, esophageal pain, esophageal ulcer, fecal incontinence, hematemesis, intestinal obstruction, pancreatitis, peptic ulcer, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema
Frequency not reported: Anal/esophageal/gastric/upper and lower GI/hemorrhoidal/peritoneal/rectal hemorrhage, bleeding esophageal varices, enterocolitis, esophageal/duodenal/gastric ulcer hemorrhage, GI bleeding, gingival/mouth bleeding, hematochezia, hemorrhagic diarrhea/diverticulitis/gastritis, intraabdominal hemorrhage[Ref]
Very common (10% or more): Rhinitis (up to 23%), pharyngitis (up to 11%), yawn/yawning (up to 11%)
Common (1% to 10%): Epistaxis, sinusitis
Rare (less than 0.1%): Apnea, atelectasis, decreased cough, emphysema, hemoptysis, hypoventilation, hypoxia, larynx edema, lung edema, pneumothorax, pulmonary events (inflammatory processes of varying histopathology and/or fibrosis), stridor
Frequency not reported: Increased cough, interstitial lung disease, pneumonitis
Very common (10% or more): Asthenia/fatigue (up to 21%),
Uncommon (0.1% to 1%): Abortion, face edema, feeling abnormal, feeling hot/cold, malaise
Rare (less than 0.1%): Deafness, hypothermia, mucosal hemorrhage
Frequency not reported: Growth delay, hyperthermia, pain
Decreased weight gain has been observed in association with use in children and adolescents.[Ref]
Very common (10% or more): Anorexia (up to 17%)
Common (1% to 10%): Decreased appetite, increased appetite, weight loss
Frequency not reported: Decreased alkaline phosphatase levels
Urinary retention and galactorrhea have been reported with other SSRIs.
The estimates of the incidence of untoward sexual experience and performance may underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue. In placebo-controlled clinical trials ejaculation disorder (primarily ejaculation delay) was reported as a treatment-emergent side effect at an incidence of 6% and at least twice the incidence in placebo-treated male patients.[Ref]
Very Common (10% or more): Decreased libido/loss of libido (up to 11%)
Uncommon (0.1% to 1%): Albuminuria, amenorrhea, anorgasmia, breast enlargement, breast pain, dysuria, female lactation, fibrocystic breast, hematuria, impaired urination, increased libido, leukorrhea, menorrhagia, metrorrhagia, nocturia, pelvic pain, polyuria, sexual dysfunction (occasionally persisting after treatment discontinuation), urinary incontinence, urinary retention, vaginal hemorrhage
Rare (less than 0.1%): Breast engorgement, glycosuria, hypomenorrhea, uterine hemorrhage, uterine fibroids enlarged
Frequency not reported: Delayed ejaculation, delayed sexual maturation, dysfunctional uterine bleeding, ejaculation dysfunction/failure, galactorrhea, genital hemorrhage, menometrorrhagia, orgasmic dysfunction, polymenorrhea, postmenopausal hemorrhage, premature ejaculation, retrograde ejaculation, uterine cervix hemorrhage, vaginal bleeding after drug withdrawal
Postmarketing reports: Enlarged clitoris, pollakiuria[Ref]
Very Common (10% or more): Flu syndrome (up to 12%)
Common (1% to 10%): Infection
Patients have developed QT prolongation of at least 450 msec.[Ref]
Common (1% to 10%): Chest pain, flushing/hot flush, hypertension, palpitation, QT-interval prolongation, vasodilatation
Rare (less than 0.1%): Bradycardia, extrasystoles, heart block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasculitis, vasospasm, ventricular arrhythmia, ventricular extrasystoles, ventricular fibrillation
Frequency not reported: Labile blood pressure, tachycardia
Rare (less than 0.1%): Epidermal necrolysis/toxic epidermal necrolysis, erythema multiforme, furunculosis, hirsutism, petechia, photosensitivity reaction, psoriasis, purpura, purpuric rash, seborrhea, Stevens Johnson syndrome/Lyell syndrome
Frequency not reported: Erythema, exfoliative rash, heat rash, erythematous rash, follicular rash, generalized rash, macular rash, morbilliform rash, papular rash, pruritic rash, vesicular rash, umbilical erythema rash
Postmarketing reports: Erythema nodosum, exfoliative dermatitis, thrombocytopenic purpura[Ref]
Alopecia was usually reversible.[Ref]
Common (1% to 10%): Abnormal vision, vision blurred
Uncommon (0.1% to 1%): Conjunctivitis, dry eyes, mydriasis, photophobia
Frequency not reported: Increased intraocular pressure
Common (1% to 10%): Arthralgia, muscle twitching/twitching
Uncommon (0.1% to 1%): Arthritis, bone pain, bursitis, leg cramps, tenosynovitis
Common (1% to 10%): Allergic reaction
Rare (less than 0.1%): Biliary pain, cholecystitis, hepatitis, idiosyncratic hepatitis, liver fatty deposits, transaminases increased, gamma glutamyltransferase increased
Uncommon (0.1% to 1%): Hypothyroidism
Rare (less than 0.1%): Inappropriate secretion of antidiuretic hormone
Frequency not reported: Gynecomastia, hyperprolactinemia[Ref]
Uncommon (0.1% to 1%): Albuminuria
Rare (less than 0.1%): Blood urea nitrogen (BUN) increased, kidney pain, oliguria
Frequently asked questions
- SSRI’s vs SNRI’s - What's the difference between them?
- Prozac vs Zoloft - What are the Differences & Similarities?
- What are some common side effects of antidepressants?
- If I'm on fluoxetine, what can I take for a bad cough associated with a cold or strep throat?
More about Rapiflux (fluoxetine)
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Drug class: selective serotonin reuptake inhibitors
Related treatment guides
1. "Product Information. Prozac (fluoxetine)." Dista Products Company (2001):
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.